protocol_id stringclasses 263
values | section_number stringlengths 1 12 | title stringlengths 1 1.88k | content stringlengths 0 866k | merged_titles listlengths 0 491 |
|---|---|---|---|---|
NCT03569631 | 8.13.1.3.2 | Clinical Global Impression Improvement: Investigator –Rated (CGI-I) | 8.13.1.3.2 Clinical Global Impression Improvement: Investigator –Rated (CGI-I) The Clinical Global Impression – Improvement (CGI-I) assessment is a 7-point scale that requires the clinician to assess how much the subject's illness has improved or worsened relative to a baseline state at the beginning of the interventio... | [] |
NCT03569631 | 8.13.1.4 | VAS Rating Scale | 8.13.1.4 VAS Rating Scale In an attempt to measure the level of behavioral difficulty experienced by the parent/caregiver with respect to the child with FXS, the VAS will allow parents to mark on a visual line measuring 10 cm with one side marked "worst behavior" and the other side marked "best behavior." The caregiver... | [] |
NCT03569631 | 8.13.1.5 | Aberrant Behavior Checklist (ABC) | 8.13.1.5 Aberrant Behavior Checklist (ABC) The Aberrant Behavior Checklist- Community Edition (ABC) is a 58-item parent/caregiver rating scale used to assess behaviors across five dimensions or subscales: irritability, hyperactivity, lethargy/withdrawal, stereotypy, and inappropriate speech.18 Items are evaluated on a ... | [] |
NCT03569631 | 8.13.1.6 | Anxiety Depression and Mood Scale (ADAMS) | 8.13.1.6 Anxiety Depression and Mood Scale (ADAMS) The ADAMS (Anxiety, Depression, and Mood Scale) is a 28-item behavior-based informant instrument rated by the parent/caregiver and designed to assess anxiety, depression and mood disorders in individuals with intellectual disability.19 Items are rated on a scale of 0 (... | [] |
NCT03569631 | 8.13.1.7 | Vineland-3 Rating Scale | 8.13.1.7 Vineland-3 Rating Scale The Vineland Adaptive Behavior Scales, Third Edition (Vineland-3)20 assesses adaptive behavior in five domains, each with subdomains. The following three domains will be assessed in this study, as most applicable to the FXS population: - 1. Communication - o Subdomains: Receptive, Expre... | [] |
NCT03569631 | 8.13.1.8 | Event-Related Potentials (ERP) | 8.13.1.8 Event-Related Potentials (ERP) Event-Related Potentials (ERPs) enable extraction of neural responses associated with specific sensory, cognitive, or motor events from an overall EEG. 21,22Auditory stimuli are presented and EEG events assessed in relation to timing of the stimuli. For this study, an ERP protoco... | [] |
NCT03569631 | 8.13.1.9 | Eye Tracking | 8.13.1.9 Eye Tracking Eye tracking has been successfully used to assess social gaze in FXS.24 Testing will be conducted in a quiet room with the lights turned off. The eye tracker (Tobii) will be calibrated for each subject at the beginning of each session. Following calibration, subjects will view pictures shown on th... | [] |
NCT03569631 | 8.13.2 | Timing of Efficacy Assessments | 8.13.2 Timing of Efficacy Assessments | [] |
NCT03569631 | 8.13.2.1 | Baseline (Period 1/Day 1) | 8.13.2.1 Baseline (Period 1/Day 1) The following exploratory efficacy assessments will be performed at Baseline (Period 1/ Day 1, prior to randomization): - x NIH Toolbox Cognitive Battery for Intellectual Disabilities (NIH-TCB) - x Test of Attentional Performance (KiTAP) - x Clinical Global Impression Severity Investi... | [] |
NCT03569631 | 8.13.2.2 | Week 6 (Periods 1 and 2) | 8.13.2.2 Week 6 (Periods 1 and 2) The following cognitive tests will be assessed at Week 6 during each Period: - x NIH Toolbox Cognitive Battery for Intellectual Disabilities (NIH-TCB) - x Test of Attentional Performance (KiTAP) - x Clinical Global Impression Severity Investigator rated (CGI-S) - x Clinical Global Impr... | [] |
NCT03569631 | 8.13.2.3 | Week 12 (Periods 1 and 2) | 8.13.2.3 Week 12 (Periods 1 and 2) The full battery of cognitive tests will be performed at Week 12 during each Period: - x NIH Toolbox Cognitive Battery for Intellectual Disabilities (NIH-TCB) - x Test of Attentional Performance (KiTAP) - x Clinical Global Impression Severity Investigator rated (CGI-S) Protocol: BPN14... | [] |
NCT03569631 | 8.14 | Pharmacokinetic Assessment | 8.14 Pharmacokinetic Assessment | [] |
NCT03569631 | 8.14.1 | Plasma Pharmacokinetic Samples | 8.14.1 Plasma Pharmacokinetic Samples Blood samples for BPN14770 concentrations will be drawn at screening and during the clinic visit at Week12 during each Period. Samples will be drawn at the time of the clinic visit, with documentation of time of day testing was performed, and time of day of most recent dose of stud... | [] |
NCT03569631 | 8.14.2 | Processing and Shipment of Pharmacokinetic Samples | 8.14.2 Processing and Shipment of Pharmacokinetic Samples Blood samples will be kept on wet ice from the time of collection and throughout processing until frozen. Blood samples will be centrifuged at 1500 x g (gravity) for 10 minutes at 4°C. The resulting plasma samples will be harvested and transferred into appropria... | [] |
NCT03569631 | 8.14.3 | Analytical Method | 8.14.3 Analytical Method Plasma samples will be analyzed for BPN14770 using a validated assay.25 Samples will only be analyzed for subjects whose treatment included administration of BPN14770. Samples will not be analyzed when matching placebo for BPN14770 was administered. | [] |
NCT03569631 | 8.14.4 | Plasma Pharmacokinetic Parameters | 8.14.4 Plasma Pharmacokinetic Parameters BPN14770 plasma levels will be presented in tabular form by Period at Week 12, and a listing of all subjects' data will be provided. | [] |
NCT03569631 | 8.15 | Biomarker Assessments | 8.15 Biomarker Assessments Biomarker samples will be collected concurrently with the pharmacokinetic samples at screening and at the Week 12 visits at the end of each Period. Samples will be processed in the same manner as the pharmacokinetic samples (see Section 8.14.2). Biomarker samples will be shipped to the sponso... | [] |
NCT03569631 | 9 | EVALUATION AND REPORTING OF ADVERSE EVENTS | 9 EVALUATION AND REPORTING OF ADVERSE EVENTS | [] |
NCT03569631 | 9.1 | Adverse Events | 9.1 Adverse Events An adverse event is defined as any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An adverse event can therefore be any unfavorable and/or unintended sign (including an a... | [] |
NCT03569631 | 9.2 | Definitions | 9.2 Definitions | [] |
NCT03569631 | 9.2.1 | Adverse Drug Reaction | 9.2.1 Adverse Drug Reaction For adverse events with a causal relationship to study drug, follow-up by the Investigator will be required until the event or its sequelae resolve or stabilize to a level acceptable to the Investigator. | [] |
NCT03569631 | 9.2.2 | Unexpected Adverse Event/ Unexpected Adverse Drug Reaction | 9.2.2 Unexpected Adverse Event/ Unexpected Adverse Drug Reaction An unexpected AE/unexpected suspected adverse reaction is an AE or suspected adverse reaction that is not listed in the Investigator Brochure or is not listed at the specificity or severity that has been observed; or, if an Investigator Brochure is not re... | [] |
NCT03569631 | 9.2.3 | Serious Adverse Events | 9.2.3 Serious Adverse Events An adverse event or adverse reaction is considered serious if, in the view of either the Investigator or Sponsor, it results in any of the following outcomes: - x Death; - x A life-threatening adverse event; - x NOTE: An adverse event or adverse reaction is considered "life-threatening" if,... | [] |
NCT03569631 | 9.3 | Assessment of Adverse Events by the Investigator | 9.3 Assessment of Adverse Events by the Investigator | [] |
NCT03569631 | 9.3.1 | Causality/Relatedness | 9.3.1 Causality/Relatedness The relationship of an adverse event to the administration of the study drug is to be assessed by the Investigator according to the following definitions: Not Related (unlikely related, unrelated, not related, no relation) – The time course between the administration of study drug and the oc... | [] |
NCT03569631 | 9.3.2 | Severity | 9.3.2 Severity The Investigator is responsible for assessing the severity (intensity) of each adverse event as mild, moderate, or severe according to the following definitions: Mild – An event that is easily tolerated and generally not interfering with normal daily activities. Moderate – An event that is sufficiently d... | [] |
NCT03569631 | 9.3.3 | Adverse Event Monitoring and Follow-up | 9.3.3 Adverse Event Monitoring and Follow-up Subjects who experience AEs will be monitored with relevant clinical assessments and laboratory tests, as determined by the Investigator. In accordance with good medical practice, all AEs must be followed to satisfactory resolution or stabilization of the event(s), or, if a ... | [] |
NCT03569631 | 9.3.4 | Reporting Serious Adverse Events | 9.3.4 Reporting Serious Adverse Events From the time of informed consent until 30 days following the last administration of study drug the Investigator or designee will notify the sponsor contact within 24 hours after the SAE detection, observation, or report of occurrence (regardless of the relationship to study treat... | [] |
NCT03569631 | 10 | STUDY PROCEDURES AND ASSESSMENTS BY VISIT | 10 STUDY PROCEDURES AND ASSESSMENTS BY VISIT | [] |
NCT03569631 | 10.1 | Schedule of Assessments | 10.1 Schedule of Assessments The study timetable in Section 16.1 shows the schedule of planned study procedures. Every effort should be made to adhere to this procedure schedule. | [] |
NCT03569631 | 10.2 | Screening (Day -28 to Day -1) | 10.2 Screening (Day -28 to Day -1) The study will consist of a Screening period of 28 days or less. Screening and Baseline visits may be combined. Each potential study participant will have the following assessments completed by the Investigator or designee up to 28 days prior to the first dose of study medication: - x... | [] |
NCT03569631 | 10.3 | Baseline (Period 1/Day 1) | 10.3 Baseline (Period 1/Day 1) Subjects will return to the clinic for the Period 1/Day 1 Visit (Baseline) following successful screening. If clinic processes allow, the Screening and Baseline visits may be combined; in this case, it is not necessary to repeat vital signs nor to conduct the abbreviated physical exam. Pr... | [] |
NCT03569631 | 10.3.1 | Prior to Randomization | 10.3.1 Prior to Randomization The following assessments will be completed: - x Conduct abbreviated physical exam (not to be repeated if the Screening and Baseline visits occur on the same day); - x Obtain vital signs (not to be repeated if the Screening and Baseline visits occur on the same day); - x Record any updates... | [] |
NCT03569631 | 10.3.2 | Week 1 (Periods 1 and 2) | 10.3.2 Week 1 (Periods 1 and 2) The following assessments will be completed at the Week 1 Visit during each Period: - x Telephone call to: - o Assess suicidality; - o Record any updates to concomitant medication use , and - o Assess and record any adverse events. | [] |
NCT03569631 | 10.3.3 | Week 2 (Periods 1 and 2) | 10.3.3 Week 2 (Periods 1 and 2) The following assessments will be completed at the Week 2 Visit during each Period: - x Collect vital signs; - x Conduct ECG (single); - x Draw fasting blood samples for Chemistry and Hematology (following a minimum 8 hour fast); \\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\ Protoco... | [] |
NCT03569631 | 10.3.4 | Week 6 (Periods 1 and 2) | 10.3.4 Week 6 (Periods 1 and 2) The following assessments will be completed at the Week 4 Visit during Periods 1 and 2: - x Collect vital signs; - x Assess suicidality; - x Conduct the following cognitive tests: - o NIH Toolbox Cognitive Battery for Intellectual Disabilities (NIH-TCB) - o Test of Attentional Performanc... | [] |
NCT03569631 | 10.3.5 | Week 12 (Periods 1 and 2) | 10.3.5 Week 12 (Periods 1 and 2) The following assessments will be completed at the Week 12 Visit during Periods 1 and 2: - x Collect weight; - x Collect vital signs; - x Conduct ECG (single); - x Draw fasting blood samples for Chemistry and Hematology (following a minimum 8 hour fast); - x Collect urine for safety uri... | [] |
NCT03569631 | 10.3.6 | Week 13 (Period 2, Final Contact at End of Study) | 10.3.6 Week 13 (Period 2, Final Contact at End of Study) - x Telephone call to: - o Record any updates to concomitant medication use , - o Assess and record any adverse events, and - o Record final subject disposition. | [] |
NCT03569631 | 10.3.7 | Early Termination | 10.3.7 Early Termination It is hoped that all subjects can be followed through to the conclusion of the study at Period 2/Week 13. However, if an early termination occurs, the Week 12 procedures should be completed at the time of the subject's withdrawal (if possible) and an explanation provided as to why the subject i... | [] |
NCT03569631 | 11 | PLANNED STATISTICAL METHODS | 11 PLANNED STATISTICAL METHODS | [] |
NCT03569631 | 11.1 | Sample Size | 11.1 Sample Size Given the exploratory nature of this study, a definitive sample size calculation is not possible. However, for the sake of providing an evaluation of the potential power to detect a meaningful difference between treatments, a crossover study having no carryover effects with 80% power, a 5% alpha level,... | [] |
NCT03569631 | 11.2 | Demographics | 11.2 Demographics Summary statistics [number (n), mean, standard deviation (SD), minimum, median, and maximum] will be tabulated for the observed values for all continuous demographic parameters. Frequencies and percentages will be tabulated for categorical data. | [] |
NCT03569631 | 11.3 | Analysis Populations | 11.3 Analysis Populations The primary efficacy population will be the intent to treat (ITT) efficacy population, which will include all randomized subjects who received at least one dose of treatment and returned for at least one follow-up visit. The completers population (CP), defined as all randomized subjects who co... | [] |
NCT03569631 | 11.4 | Efficacy: Cognitive Testing Analysis | 11.4 Efficacy: Cognitive Testing Analysis All cognitive parameters will be summarized at each time point collected and standard descriptive statistics provided. Baseline measurements are defined as those obtained on Day 1/Period 1 prior to receipt of any study medication. For cognitive parameters measured at baseline, ... | [] |
NCT03569631 | 11.5 | Safety Analysis | 11.5 Safety Analysis Safety analysis will be based on all subjects receiving at least one dose of study medication. Treatment emergent AEs will be summarized based on the frequency of AEs and their severity for all dosed subjects. Adverse Events (AEs), including clinically meaningful laboratory abnormalities and signif... | [] |
NCT03569631 | 11.6 | Pharmacokinetic Analysis | 11.6 Pharmacokinetic Analysis BPN14770 plasma levels will be presented in listing form by Period, Treatment and subject. | [] |
NCT03569631 | 11.7 | Biomarker Analysis | 11.7 Biomarker Analysis Biomarker analysis will be exploratory and will follow reporting of the clinical study, as the biomarker analyses to be conducted may be partially determined by clinical results observed in the study. | [] |
NCT03569631 | 12 | DATA MANAGEMENT | 12 DATA MANAGEMENT | [] |
NCT03569631 | 12.1 | Data Handling | 12.1 Data Handling Data will be recorded at the site on CRFs and reviewed by the CRA during monitoring visits. The CRA will verify data recorded in the EDC system with source documents. All corrections or changes made to any study data must be appropriately tracked in an audit trail in the EDC system. A CRF will be con... | [] |
NCT03569631 | 12.2 | Computer Systems | 12.2 Computer Systems Data will be collected and processed using a validated EDC system. The system and procedures are designed in compliance with Title 21 of the Code of Federal Regulations (21 CFR Part 11). | [] |
NCT03569631 | 12.3 | Data Entry | 12.3 Data Entry Data must be recorded using the EDC system as the study is in progress. All site personnel must log into the system using their secure user name and password in order to enter, review, or \\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\ Protocol: BPN14770-CNS-203 Tetra Discovery Partners, Inc. Date: 2... | [] |
NCT03569631 | 12.4 | Data Validation | 12.4 Data Validation Validation checks programmed within the EDC system, as well as supplemental validation performed via review of the downloaded data, will be applied to the data in order to ensure accurate, consistent, and reliable data. Data identified as erroneous, or data that are missing, will be referred to the... | [] |
NCT03569631 | 13 | INVESTIGATOR REQUIREMENTS AND QUALITY CONTROL | 13 INVESTIGATOR REQUIREMENTS AND QUALITY CONTROL | [] |
NCT03569631 | 13.1 | Ethical Conduct of the Study | 13.1 Ethical Conduct of the Study The Investigator agrees, when signing the protocol, to adhere to the instructions and procedures that are described in the protocol and to conduct the study in accordance with the CFRs (21 CFR § 11, 50, 54, 56, and 312 Subpart D), which originate from the ethical principles laid down i... | [] |
NCT03569631 | 13.2 | Institutional Review Board (IRB) | 13.2 Institutional Review Board (IRB) Before initiation of the study, the Investigator must obtain approval or favorable opinion of the research protocol, informed consent form, and any advertisement for subject recruitment from an IRB complying with the provisions specified in 21 CFR §56 and applicable pertinent state... | [] |
NCT03569631 | 13.3 | Informed Consent | 13.3 Informed Consent The informed consent form (ICF) and any changes to the ICF made during the course of the study must be agreed to by the Sponsor or designee and the IRB prior to its use and must be in compliance with all ICH GCP, provisions specified in 21 CFR §50, and applicable pertinent state and federal requir... | [] |
NCT03569631 | 13.4 | Study Monitoring | 13.4 Study Monitoring The role of the study monitor is to verify the rights and well-being of the subjects are protected, the data is accurate, complete, and verifiable from source documents, and the conduct of the study is in compliance with the protocol, Declaration of Helsinki, ICH GCP, and applicable regulatory req... | [] |
NCT03569631 | 13.5 | Disclosure of Information | 13.5 Disclosure of Information It is understood by the Investigator that the information and data included in this protocol is confidential and proprietary to the Sponsor, Tetra Discovery Partners, Inc. This information may be disclosed to study personnel under the Investigator's supervision and the Institutional Revie... | [] |
NCT03569631 | 13.6 | Record Storage and Retention | 13.6 Record Storage and Retention Records of subjects, source documents, monitoring visit logs, CRFs, inventory of study product, regulatory documents, and other Sponsor correspondence pertaining to the study must be kept in the appropriate study files at the site. Source data is defined as all information in original ... | [] |
NCT03569631 | 13.7 | Protocol Amendments and Deviations | 13.7 Protocol Amendments and Deviations Any amendments to the study protocol will be communicated to the Investigator by the Sponsor or authorized representative. All protocol amendments will undergo the same review and approval process as the original protocol. A protocol amendment may be implemented only after it has... | [] |
NCT03569631 | 13.8 | Access to Source Documentation | 13.8 Access to Source Documentation The Sponsor (or the Sponsor's authorized representative) must have access to inspect all documents and records that are to be maintained by the Investigator, including, but not limited to, medical records (office, clinic, or hospital) for the subjects in this trial. These regulations... | [] |
NCT03569631 | 13.9 | Financial Disclosure | 13.9 Financial Disclosure Clinical Investigators are required to provide financial disclosure information to the Sponsor to permit the Sponsor to fulfill its obligations under 21 CFR §54. In addition, investigators must commit to promptly updating this information if any relevant changes occur during the study and for ... | [] |
NCT03569631 | 13.10 | Publication Policy | 13.10 Publication Policy Manuscript(s) and abstract(s) may only be prepared through cooperation between the Sponsor (or designee) and the study Investigator(s). The Investigator agrees not to publish or publicly present any results of the study without prior written consent of the Sponsor. Protocol: BPN14770-CNS-203 Te... | [] |
NCT03569631 | 14 | ADMINISTRATIVE INFORMATION | 14 ADMINISTRATIVE INFORMATION | [] |
NCT03569631 | 14.1 | Sponsor | 14.1 Sponsor Tetra Discovery Partners, Inc. 38 Fulton Street West, Suite 303 Grand Rapids, MI 4953-2684 Phone: 616.635.0937 | [] |
NCT03569631 | 14.2 | Biological Specimens | 14.2 Biological Specimens CMIC, Inc. 2860 Forbs Avenue Hoffman Estates, Illinois 60192-3702 Phone: 847.645.0407 Phone: 224.293.6800 Email: www.cmic-inc.com Protocol: BPN14770-CNS-203 Tetra Discovery Partners, Inc. Date: 25 June 2018 Confidential | [] |
NCT03569631 | 15 | REFERENCES | 15 REFERENCES - 1. Declaration of Helsinki (Fortaleza, October 2013) Seventh revision, 64th World Medical Association General Assembly Meeting. - 2. International Conference on Harmonisation (ICH) E6 (R1) Good Clinical Practice Guideline. - 3. Burgin AB, Magnusson OT, Singh J, et al. Design of Phosphodiesterase Type 4D... | [] |
NCT03569631 | 16 | Appendices | 16 Appendices | [] |
NCT03569631 | 16.1 | Schedule of Assessments | 16.1 Schedule of Assessments | | Screening | CrossPERIOD 1over | | | | | | | FollowUp/ | | | | | |-------------------------------------|--------------------|---------------------------|---------------|-----|-----------|---------------------|--|----|---------------|------|------|-----------------------------------------... | [] |
NCT03569631 | 16.2 | Clinical Laboratory Analytes | 16.2 Clinical Laboratory Analytes
Standard Chemistry Alanine aminotransferase (ALT) Albumin Alkaline phosphatase Aspartate aminotransferase (AST) Bicarbonate Blood urea nitrogen (BUN) Calcium Chloride Creatinine Glucose Potassium Sodium Total bilirubin Total protein Hematology Hematocrit Hemoglobin Platelet count Red ... | [
"Standard Chemistry"
] |
NCT03582215 | 1 | Protocol Synopsis | 1. Protocol Synopsis | Protocol Number: | SCR-005 | |-------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------... | [
"Summary and Objectives:",
"Study Design: Part 1 Part 1 is an open-label, randomized, 4-arm pilot study to evaluate the effects of multiple applications of 4 different topical sunscreen formulations in healthy adult subjects. Each arm will include 6 subjects (3 male and 3 female) with 1 formulation. A total of 24... |
NCT03582215 | 2 | List of Abbreviations | 2. List of Abbreviations | Abbreviation | Definition | |--------------|-------------------------------------------------------------------------------------------------------------------------------------| | AE | adverse event | | AUC | area under the concentration-time curve | | AUC0-24 | area under the concentration-... | [] |
NCT03582215 | 3 | Introduction | 3. Introduction Sunscreens prevent skin damage by reflecting or absorbing ultraviolet (UV) radiation and they are regulated as drug products in the United States (U.S.). Most active ingredients in sunscreens are organic chemicals and some have been shown to be absorbed through human skin with detectable levels in the b... | [] |
NCT03582215 | 4 | Study Objectives | 4. Study Objectives | [] |
NCT03582215 | 4.1 | Primary Objectives | 4.1. Primary Objectives | [] |
NCT03582215 | 4.1.1 | Part 1 | 4.1.1 Part 1 Part 1 is an open-label, randomized, 4-arm study in 24 healthy adult subjects with the primary objective: To explore whether the active components (avobenzone, oxybenzone, ecamsule and octocrylene) of 4 sunscreen products (1 sunscreen product in each arm) are absorbed into the systemic circulation when sun... | [] |
NCT03582215 | 4.1.2 | Part 2 | 4.1.2 Part 2 Part 2 is an open-label, 4-arm study in 48 healthy adult subjects with the following primary objective: To assess, where applicable, the pharmacokinetics and systemic absorption of the active components (avobenzone, oxybenzone, octocrylene, ecamsule, homosalate, octisalate and octinoxate) of 4 sunscreen pr... | [] |
NCT03582215 | 5 | Investigational Plan | 5. Investigational Plan | [] |
NCT03582215 | 5.1 | Study Design | 5.1. Study Design This will be a single clinical study conducted in 2 parts. The duration of study participation will be approximately 37 days for part 1, including a 30-day screening period, a 4-day treatment period (Days 1-4) and subjects leaving the clinic on the morning of Day 7 following completion of scheduled En... | [] |
NCT03582215 | 5.1.1 | Part 1 | 5.1.1 Part 1 Part 1 is an open-label, randomized, 4-arm pilot study to evaluate the effects of multiple applications of 4 different topical sunscreen formulations in healthy adult subjects. Each arm will include 6 subjects (3 male and 3 female) with 1 formulation. A total of 24 subjects (12 male and 12 female) from all... | [] |
NCT03582215 | 5.1.2 | Part 2 | 5.1.2 Part 2 Part 2 is an open-label, 4-arm-study to evaluate the pharmacokinetics of avobenzone, oxybenzone, octocrylene, homosalate, octisalate and octinoxate (Part 2 products will not contain ecamsule) after multiple applications of a topical sunscreen formulation in healthy adult subjects. Part 2 will include 48 su... | [] |
NCT03582215 | 5.1.3 | Tape Stripping | 5.1.3 Tape Stripping For Part 2 only, skin tape stripping (6 consecutive strippings) of the lower back (area: around 3.8 cm2 ) will be conducted once on Days 7 and 14 to determine residual sunscreen active ingredients in the superficial layers of the skin. The intention of the stripping is to determine the concentratio... | [] |
NCT03582215 | 5.1.4 | Common Procedures | 5.1.4 Common Procedures Details of study visits and study procedures are described in Section 5.6 and Section 5.7, respectively, and the overall Schedule of Events for both parts of the study is presented in Section 10.1. In both parts of the study, approximately 2 mg of sunscreen per 1 cm2 of body surface (calculation... | [] |
NCT03582215 | 5.1.5 | Risk/Benefit | 5.1.5 Risk/Benefit Subjects will be informed that participation in a human PK study like the present one cannot be of benefit to healthy volunteers. Nevertheless, the information from the physical examination, vital sign measurements, and ECG results may be shared with the subject's personal physician if this is the su... | [] |
NCT03582215 | 5.2 | Selection of Study Population | 5.2. Selection of Study Population Subjects will be screened and the data collected will be reviewed by the principal investigator. Only those subjects who meet all of the eligibility criteria will be enrolled. | [] |
NCT03582215 | 5.2.1 | Inclusion Criteria | 5.2.1 Inclusion Criteria Subjects who meet all of the following inclusion criteria will be eligible to participate in the study: - 1. Subject signs an institutional review board (IRB)-approved written informed consent and privacy language as per national regulations (e.g., Health Insurance Portability and Accountabilit... | [] |
NCT03582215 | 5.2.2 | Exclusion Criteria | 5.2.2 Exclusion Criteria Subjects who meet any of the following exclusion criteria will not be eligible to participate in the study: - 1. Subject has broken, irritated, or unhealed skin. - 2. Subject has an active sunburn. - 3. Subject has used a tanning bed in the previous 4 weeks. - 4. Subject has known skin or autoi... | [] |
NCT03582215 | 5.3 | Screening Failures | 5.3. Screening Failures Subjects who sign and date the informed consent form but who fail to meet the inclusion and exclusion criteria are defined as screening failures. A screening log, which documents the subject initials and reason(s) for screening failure, will be maintained by the investigator for all screening fa... | [] |
NCT03582215 | 5.4 | Termination of Study or Investigational Site | 5.4. Termination of Study or Investigational Site | [] |
NCT03582215 | 5.4.1 | Criteria for Termination of the Study | 5.4.1 Criteria for Termination of the Study The study will be completed as planned unless one of the following criteria is satisfied that requires early termination of the study: - New information regarding the safety or efficacy of the study product(s) that indicates a change in the known risk profile for the study dr... | [] |
NCT03582215 | 5.4.2 | Criteria for Termination of Investigational Site | 5.4.2 Criteria for Termination of Investigational Site The study site may be terminated if the site (including the investigator) is found in significant violation of GCP, the protocol, the contractual agreement, or is unable to ensure adequate performance of the study. In the event that the sponsor elects to terminate ... | [] |
NCT03582215 | 5.5 | Criteria for Subject Withdrawal | 5.5. Criteria for Subject Withdrawal Subjects may withdraw from the study at any time at their own request, or they may be withdrawn by the investigator without the approval of the subject based on the investigator's clinical judgment. A subject is not required to provide a written request to withdraw from the study; h... | [] |
NCT03582215 | 5.5.1 | Handling of Withdrawals | 5.5.1 Handling of Withdrawals The investigator may terminate a subject's study participation at any time during the study when the subject meets the criteria described in Section 5.5. In addition, a subject may discontinue his or her participation without giving a reason at any time during the study. Subjects will be i... | [] |
NCT03582215 | 5.5.2 | Replacement Subjects | 5.5.2 Replacement Subjects Approximately 72 healthy subjects are planned for enrollment, of which 24 subjects will be enrolled and randomized in Part 1 and 48 subjects will be enrolled and randomized in Part 2. Up to 18 subjects may be qualified as replacements. Thus, a maximum of 90 subjects may be exposed to study dr... | [] |
NCT03582215 | 5.6 | Study Visits | 5.6. Study Visits | [] |
NCT03582215 | 5.6.1 | Recruitment | 5.6.1 Recruitment Recruitment materials (e.g., internet, radio, and print advertisements, social media posts) will be approved by the local IRB before telephone screening. The sponsor is responsible for registration of the study on clinicaltrials.gov; however, this may not occur until the IRB has approved the final stu... | [] |
NCT03582215 | 5.6.1.1 | Compensation | 5.6.1.1 Compensation Subjects will be offered payment for Screening; however, if the results of their alcohol and drug screening tests are positive, they will not be compensated. Subjects who complete the entire study (Day 0 to Day 7 in Part 1 or Day 0 to Day 21 in Part 2) will receive payment according to the schedule... | [] |
NCT03582215 | 5.6.2 | Screening | 5.6.2 Screening The following procedures and assessments will be performed at Screening (Day –30 to Day –1): Obtain informed consent/HIPAA authorization (The informed consent process will be performed by a clinical research nurse in a private room. The subject will be given unlimited time to ask questions regarding stu... | [] |
NCT03582215 | 5.6.3 | Study Periods | 5.6.3 Study Periods Part 1 and Part 2 of this study are open-label, randomized, 4-arm designs. Part 1 of the study has 1 treatment period and 3 follow-up days; subjects stay in the clinic for the full treatment and follow-up period. Part 2 of the study has 1 treatment period and 6 followup days; subjects stay in the cl... | [] |
NCT03582215 | 5.6.3.1 | Check-in | 5.6.3.1 Check-in The following procedures and assessments will be performed at Check-in (Day 0) as outlined in Appendix A: Schedule of Events: - Review inclusion/exclusion criteria to confirm subject eligibility - Perform drug and alcohol screening (amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, al... | [] |
Subsets and Splits
No community queries yet
The top public SQL queries from the community will appear here once available.