protocol_id stringclasses 263
values | section_number stringlengths 1 12 | title stringlengths 1 1.88k | content stringlengths 0 866k | merged_titles listlengths 0 491 |
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NCT02903914 | 16.1.1 | Definitions | 16.1.1 Definitions For the purposes of this Protocol, an adverse event (AE) is defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related, that occurs after a subject provides informed consent. Abnormal laboratory values or test results occurring after... | [] |
NCT02903914 | 16.1.2 | Reporting | 16.1.2 Reporting Adverse events that begin or worsen after informed consent should be recorded on the Adverse Events form of the eCRF. Conditions that were already present at the time of informed consent should be recorded on the Medical History form in the eCRF. Monitoring for the occurrence of new AEs should be conti... | [] |
NCT02903914 | 16.2 | Laboratory Test Abnormalities | 16.2 Laboratory Test Abnormalities Laboratory abnormalities that constitute an AE in their own right (considered clinically meaningful, induce clinical signs or symptoms, require concomitant therapy, or require changes in study drug) should be recorded on the Adverse Event form in the eCRF. Whenever possible, a diagnos... | [] |
NCT02903914 | 16.3 | Serious Adverse Events | 16.3 Serious Adverse Events | [] |
NCT02903914 | 16.3.1 | Definitions | 16.3.1 Definitions An SAE is defined as an event that meets at least 1 of the following criteria: - Is fatal or life-threatening. - Requires inpatient hospitalization or prolongation of existing hospitalization, unless hospitalization is a result of: - β A routine treatment or monitoring of the studied indication not a... | [] |
NCT02903914 | 16.3.2 | Reporting | 16.3.2 Reporting For Parts 1a and 2, every SAE, regardless of suspected causality (eg, relationship to study drug(s) or study procedure or disease progression), occurring after the subject has signed the ICF through 30 days after the last dose of study treatment, or until the subject receives a new anticancer therapy (... | [] |
NCT02903914 | 16.4 | Pregnancy | 16.4 Pregnancy Pregnancy, in and of itself, is not regarded as an AE unless there is suspicion that the study treatment(s) may have interfered with the effectiveness of a contraceptive medication or method. When a pregnancy has been confirmed in a patient during maternal or paternal exposure to study treatment(s), the ... | [] |
NCT02903914 | 16.5 | Definition of an Overdose for This Protocol and Reporting of Overdose to the Sponsor | 16.5 Definition of an Overdose for This Protocol and Reporting of Overdose to the Sponsor For this study, an overdose of each study treatment is defined as follows: - INCB001158: A dose that is higher than the dose that patient has been intended to receive, which could be either the originally assigned dose (if not sub... | [] |
NCT02903914 | 16.6 | Warnings and Precautions | 16.6 Warnings and Precautions Special warnings or precautions for the INCB001158 study drug and for pembrolizumab, derived from safety information collected by the sponsor or its designee, are presented in the Investigator's Brochures (iIB, pIB). Additional safety information collected between IB updates will be commun... | [] |
NCT02903914 | 16.7 | Product Complaints | 16.7 Product Complaints The sponsor collects product complaints on study drugs and drug delivery systems used in clinical studies in order to ensure the safety of study participants, monitor quality, and facilitate process and product improvements. All product complaints associated with material packaged, labeled, and ... | [] |
NCT02903914 | 17.0 | STUDY SUSPENSION, TERMINATION, AND COMPLETION | 17.0 STUDY SUSPENSION, TERMINATION, AND COMPLETION The Sponsor may suspend or terminate the study or any part of the study at any time for any reason. If the Investigator suspends or terminates the study, the Investigator will promptly inform the Sponsor and the IRB/IEC and provide a detailed written explanation. The I... | [] |
NCT02903914 | 18.0 | INFORMED CONSENT | 18.0 INFORMED CONSENT The Investigator will provide for the protection of the patients by following all applicable regulations. These regulations are available upon request from the Sponsor. The Informed Consent Form used during the informed consent process must be reviewed by the Sponsor and approved by the IRB/IEC. A... | [] |
NCT02903914 | 19.0 | PROTOCOL AMENDMENTS | 19.0 PROTOCOL AMENDMENTS Any significant change in the study requires a protocol amendment. An Investigator must not make any changes to the study without IRB/IEC and Sponsor approval. All protocol amendments must be reviewed and approved following the same process as the original protocol. | [] |
NCT02903914 | 20.0 | QUALITY CONTROL AND ASSURANCE | 20.0 QUALITY CONTROL AND ASSURANCE The Sponsor or designee performs quality control and assurance checks on all clinical studies that it sponsors. Before enrolling any patients in this study, Sponsor personnel and the Investigator review the protocol, the Investigator's Brochure, the eCRFs and instructions for their co... | [] |
NCT02903914 | 21.0 | ETHICAL CONSIDERATIONS AND ADMINISTRATIVE PROCEDURES | 21.0 ETHICAL CONSIDERATIONS AND ADMINISTRATIVE PROCEDURES | [] |
NCT02903914 | 21.1 | Investigator Responsibilities | 21.1 Investigator Responsibilities This study will be performed in accordance with ethical principles that originate in the Declaration of Helsinki and conducted in adherence to the study Protocol; GCPs as defined in Title 21 of the US CFR Parts 11, 50, 54, 56, and 312; ICH E6 GCP consolidated guidelines; and local reg... | [] |
NCT02903914 | 21.2 | Accountability, Handling, and Disposal of Study Drug | 21.2 Accountability, Handling, and Disposal of Study Drug The investigator is responsible for drug accountability at the study site; however, some of the drug accountability duties may be assigned to an appropriate pharmacist or other designee. Inventory and accountability records must be maintained and readily availab... | [] |
NCT02903914 | 21.3 | Data Management | 21.3 Data Management Data management will be performed in a validated database via an Electronic Data Capture (EDC) system. All data entry, verification, and validation will be performed in accordance with the current standard operating procedures of the Data Management Department at the sponsor or its designee. The da... | [] |
NCT02903914 | 21.4 | Data Privacy and Confidentiality of Study Records | 21.4 Data Privacy and Confidentiality of Study Records The investigator and the sponsor or its designee must adhere to applicable data protection laws and regulations. The investigator and the sponsor or its designee are responsible for ensuring that sensitive personal information is handled in accordance with local da... | [] |
NCT02903914 | 21.5 | Financial Disclosure | 21.5 Financial Disclosure Before study initiation, all clinical investigators participating in clinical studies subject to FDA Regulation Title 21 Code of Federal Regulations (CFR) Part 54 β Financial Disclosure by Clinical Investigators (ie, "covered studies") are required to submit a completed Clinical Investigator F... | [] |
NCT02903914 | 21.6 | Publication Policy | 21.6 Publication Policy By signing the study Protocol, the investigator and his or her institution agree that the results of the study may be used by the sponsor, Incyte Corporation (Incyte), for the purposes of national and international registration, publication, and information for medical and pharmaceutical profess... | [] |
NCT02903914 | 22.0 | REFERENCES | 22.0 REFERENCES Bode-BΓΆger, SM., BΓΆger RH, Galland A, Tsikas D, and FrΓΆlich JC. Arginine-induced vasodilation in healthy humans: Pharmacokinetic-pharmacodynamic relationship. Br J Clin Pharmacology 1998;46(5): 489-97. Borghaei H, Paz-Ares L, Spigel DR, Steins M, Ready, NE, Chow LQ, et al. Nivolumab versus docetaxel in ... | [
"ATTACHMENT 1A: SCHEDULE OF STUDY ASSESSMENTS FOR PART 1A AND PART 2 (INCB001158 MONOTHERAPY)",
"Explanation of Superscripts",
"ATTACHMENT 1B: SCHEDULE OF STUDY ASSESSMENTS FOR PARTS 1B, 1C, AND 3 (INCB001158 + PEMBROLIZUMAB)",
"10 NOV 2020 Amendment 2-US 3",
"Explanation of Superscripts",
"ATTACHMENT 2A:... |
NCT02959138 | 1 | INTRODUCTION | 1. INTRODUCTION | [] |
NCT02959138 | 1.1 | Background | 1.1. Background GS-9876 is a potent and selective inhibitor of SYK and is being developed by Gilead Sciences, Inc. (Gilead) as an oral agent for the treatment of inflammatory diseases. Spleen tyrosine kinase is a nonreceptor cytoplasmic tyrosine kinase primarily expressed in cells of hematopoietic lineage, where it fun... | [] |
NCT02959138 | 1.2 | GS-9876 | 1.2. GS-9876 | [] |
NCT02959138 | 1.2.1 | General Information | 1.2.1. General Information For further information on GS-9876 refer to the current investigator's brochure (IB). | [] |
NCT02959138 | 1.2.2 | Preclinical Pharmacology, Pharmacokinetics and Toxicology | 1.2.2. Preclinical Pharmacology, Pharmacokinetics and Toxicology | [] |
NCT02959138 | 1.2.2.1 | Nonclinical Pharmacology and Safety Pharmacology | 1.2.2.1. Nonclinical Pharmacology and Safety Pharmacology GS-9876 is a selective and potent adenosine triphosphate (ATP)-competitive inhibitor of SYK with an IC50value of 9.5 nM. Overall, GS-9876 is at least 7-fold more selective biochemically for SYK relative to all other protein kinases assayed. Functionally, GS-9876... | [] |
NCT02959138 | 1.2.2.2 | Nonclinical Toxicology | 1.2.2.2. Nonclinical Toxicology In the repeat-dose studies, the toxicity profile of GS-9876 was assessed in rats and monkeys administered GS-9876 orally for up to 26 weeks. Dose-dependent effects on lymphocytes in both rats and monkeys were consistent with the expected pharmacology of SYK inhibition. Effects on hemosta... | [] |
NCT02959138 | 1.2.2.3 | Nonclinical Drug Metabolism and Pharmacokinetics | 1.2.2.3. Nonclinical Drug Metabolism and Pharmacokinetics GS-9876 exhibits high absorption in rats, dogs and monkeys. Plasma protein binding is moderate in all species with the mean free fraction in humans being of 20.4%. After oral dosing to albino and pigmented rats, [14C]GS-9876-derived radioactivity was rapidly dis... | [] |
NCT02959138 | 1.2.3 | Additional Clinical Studies of GS-9876 | 1.2.3. Additional Clinical Studies of GS-9876 As of 12 February 2016, 62 healthy volunteers have been dosed with GS-9876 in two clinical studies. | [] |
NCT02959138 | 1.2.3.1 | Completed Clinical Trial | 1.2.3.1. Completed Clinical Trial GS-US-379-1372: This was a first-in-human, Phase 1, single-dose ranging study of GS-9876 in healthy adult volunteers to evaluate the safety, tolerability, PK, PD, food effect, and drug-drug b Margins of exposure were calculated using predicted 20 mg single dose exposure in humans of 28... | [] |
NCT02959138 | 1.2.3.2 | Ongoing Clinical Trials | 1.2.3.2. Ongoing Clinical Trials GS-US-379-1582: This is a 12 week proof of concept trial of GS-9876 in patients with RA to evaluate efficacy, safety, tolerability and PK of GS-9876. GS-US-379-1900: This is a single- and multiple-dose Phase 1 study of GS-9876 in healthy volunteers to evaluate the safety, tolerability, ... | [] |
NCT02959138 | 1.3 | Rationale for This Study | 1.3. Rationale for This Study Renal dysfunction may alter the elimination of drugs resulting in PK and subsequently pharmacodynamic changes. Available data indicate the disposition of GS-9876 is primarily via hepatic metabolism and elimination with minimal excretion expected in urine. In a nonclinical ADME study in rat... | [] |
NCT02959138 | 1.4 | Rationale for the Dose Selection | 1.4. Rationale for the Dose Selection The dose of GS-9876 to be used in this study is a 20 mg single dose in the fasted state. Results from study GS-US-379-1372 indicated that GS-9876 was safe and well tolerated when administered as a single dose of 2 mg to 50 mg. Similarly, preliminary results from study GS-US-379-190... | [] |
NCT02959138 | 1.5 | Risk/Benefit Assessment for the Study | 1.5. Risk/Benefit Assessment for the Study While there is no direct benefit for the subject participating in the renal impairment study of GS-9876, the risks are considered to be minimal for the following reasons: GS-9876 has been in a battery of nonclinical animal studies, and no renal toxicity was identified. GS-9876... | [] |
NCT02959138 | 1.6 | Compliance | 1.6. Compliance This study will be conducted in compliance with this protocol, Good Clinical Practice (GCP), and all applicable regulatory requirements. | [] |
NCT02959138 | 2 | OBJECTIVES | 2. OBJECTIVES The primary objective of this study is as follows: To evaluate the pharmacokinetics (PK) of GS-9876 in subjects with impaired renal function relative to matched healthy controls. The secondary objective of this study is as follows: To evaluate the safety and tolerability of GS-9876 in subjects with normal... | [] |
NCT02959138 | 3 | STUDY DESIGN | 3. STUDY DESIGN | [] |
NCT02959138 | 3.1 | Study Design | 3.1. Study Design This protocol describes a Phase 1, open-label, parallel-group, adaptive, single-dose, multi-center, pharmacokinetic study in subjects with renal impairment and matched healthy controls. A maximum of 60 subjects using an adaptive design that includes up to 3 enrolled cohorts. - Cohort 1 (Moderate Renal... | [] |
NCT02959138 | 3.2 | Study Drug Administration | 3.2. Study Drug Administration Following an overnight fast of at least 8 hours (no food or drink except water), study drug will be administered in the morning with 240 mL of water. Subjects will continue to fast until after collection of the 4-hour PK sample, relative to study drug dosing. Additionally, subjects will b... | [] |
NCT02959138 | 3.3 | Clinic Confinement | 3.3. Clinic Confinement Following screening and Day -1 procedures, eligible subjects will be confined to the study center beginning Day -1 until completion of assessments on Day 6. Subjects will return 14 (Β± 1) days after last dose for an in-clinic follow up visit (ie. Day 15). | [] |
NCT02959138 | 3.4 | Pharmacokinetic Assessments | 3.4. Pharmacokinetic Assessments Pharmacokinetic assessments will occur on assigned study days as outlined in Table 6-1 and Section 6.7. | [] |
NCT02959138 | 3.4.1 | Plasma Pharmacokinetic Collection | 3.4.1. Plasma Pharmacokinetic Collection Plasma concentrations of GS-9876 will be measured and PK parameters determined. Plasma concentrations of GS-9876 metabolites may be determined and pharmacokinetics explored, as applicable. | [] |
NCT02959138 | 3.4.2 | Urine Pharmacokinetic Collection | 3.4.2. Urine Pharmacokinetic Collection All urine voided will be collected and pooled for the determination of PK parameters as outlined in Section 6.8.2. Urine concentrations of GS-9876, as well as its metabolites, may be analyzed. | [] |
NCT02959138 | 3.5 | Safety Assessments | 3.5. Safety Assessments Safety assessments will be performed through the study as outlined in Table 6-1 and in Section 6.9. | [] |
NCT02959138 | 3.6 | End of Study | 3.6. End of Study The end of this study will be the last subject's last observation (or visit). | [] |
NCT02959138 | 4 | SUBJECT POPULATION | 4. SUBJECT POPULATION | [] |
NCT02959138 | 4.1 | Number of Subjects and Subject Selection | 4.1. Number of Subjects and Subject Selection A total of up to 60 subjects will be enrolled in the study (up to 20 subjects per cohort), consisting of healthy male and nonpregnant, nonlactating female subjects of 18 through 75 years of age, inclusive. If necessary, replacement subjects may be enrolled if subjects do no... | [] |
NCT02959138 | 4.2 | Inclusion Criteria | 4.2. Inclusion Criteria Subjects must meet all of the following inclusion criteria to be eligible for participation in this study: | [] |
NCT02959138 | 4.2.1 | All Subjects | 4.2.1. All Subjects - 1) Have the ability to understand and sign a written informed consent form (ICF), which must be obtained prior to initiation of study procedures - 2) Be between 18 through 75 years of age, inclusive at screening - 3) Must be able to comply with the smoking restrictions at the study site. - 4) Have... | [] |
NCT02959138 | 4.2.2 | For Subjects with Renal Impairment | 4.2.2. For Subjects with Renal Impairment Subjects with mild, moderate, or severe renal impairment must also meet the following additional inclusion criteria to be eligible for participation in this study: 1) Must have diagnosis of chronic (> 6 months), stable renal impairment with no clinically significant change in r... | [] |
NCT02959138 | 4.2.3 | For Healthy Matched Controlled Subjects (Subjects with Normal Renal Function) | 4.2.3. For Healthy Matched Controlled Subjects (Subjects with Normal Renal Function) Healthy matched control subject must also meet the following additional inclusion criteria to be eligible for participation in this study: - 1) Must, in the opinion of the investigator, be in good health based upon medical history and ... | [] |
NCT02959138 | 4.3 | Exclusion Criteria | 4.3. Exclusion Criteria | [] |
NCT02959138 | 4.3.1 | All Subjects | 4.3.1. All Subjects Subjects who meet any of the following exclusion criteria will not be enrolled in this study: 1) Be a lactating female - 2) Have received any investigational compound within 30 days prior to study dosing - 3) Have current alcohol or substance abuse judged by the investigator to potentially interfere... | [] |
NCT02959138 | 4.3.2 | For Subjects with Renal Impairment | 4.3.2. For Subjects with Renal Impairment - 1) Require or are anticipated to require dialysis within 90 days of study dosing - 2) Require during the study or have received moderate or strong inhibitors or inducers of CYP3A within 2 weeks prior to study drug administration. All concomitant medications including over-the... | [] |
NCT02959138 | 4.3.3 | For Healthy Matched Controlled Subjects (Subjects with Normal Renal Function) | 4.3.3. For Healthy Matched Controlled Subjects (Subjects with Normal Renal Function) 1) Have taken any prescription medications or over-the-counter medications, including herbal products and antacids, within 28 days prior to start of study drug dosing, with the exception of vitamins and/or acetaminophen and/or ibuprofe... | [] |
NCT02959138 | 5 | STUDY DRUGS | 5. STUDY DRUGS | [] |
NCT02959138 | 5.1 | Enrollment and Treatment Code | 5.1. Enrollment and Treatment Code This is a non-randomized, open-label study. It is the responsibility of the Investigator to ensure that the subject is eligible for the study prior to enrollment. Subjects will be assigned a Screening number at the time of consent. Once eligibility has been confirmed following complet... | [] |
NCT02959138 | 5.2 | Description and Handling of GS-9876 | 5.2. Description and Handling of GS-9876 | [] |
NCT02959138 | 5.2.1 | Formulation | 5.2.1. Formulation GS-9876 will be supplied as 10 mg tablets that are round, plain-faced and film-coated blue. Each tablet contains 10 mg of GS-9876 free base as the succinate form (GS-9876-02). The GS-9876 tablets contain commonly used excipients including microcrystalline cellulose, mannitol, croscarmellose sodium, m... | [] |
NCT02959138 | 5.2.2 | Packaging and Labeling | 5.2.2. Packaging and Labeling GS-9876 tablets are packaged in white, high-density polyethylene (HDPE) bottles. Each bottle contains 30 tablets, silica gel desiccant and polyester packing material. Each bottle is enclosed with a white, continuous thread, child-resistant polypropylene screw cap with an induction-sealed a... | [] |
NCT02959138 | 5.2.3 | Storage and Handling | 5.2.3. Storage and Handling GS-9876 tablets should be stored at controlled room temperature of 25 ΒΊC (77 ΒΊF); excursions are permitted between 15 ΒΊC and 30 ΒΊC (59 ΒΊF and 86 ΒΊF). Storage conditions are specified on the label. Until dispensed to the subjects, all drug products should be stored in a securely locked area, ... | [] |
NCT02959138 | 5.3 | Dosage and Administration of Study Drug | 5.3. Dosage and Administration of Study Drug Following completion of Screening and Day -1 assessments, eligible subjects will be enrolled in 1 of the 3 cohorts and receive a single oral dose of GS-9876 20 mg (2 Γ 10 mg tablet) in a fasted state on Day 1. | [] |
NCT02959138 | 5.4 | Fasting and Meals | 5.4. Fasting and Meals Study drug will be administered in the morning with 240 mL of water. Subjects will continue to fast until after collection of the 4-hour PK sample, relative to study drug dosing. Additionally, subjects will be restricted from water consumption 1 hour before and 2 hours after dosing, except for th... | [] |
NCT02959138 | 5.5 | Accountability for Study Drug | 5.5. Accountability for Study Drug The investigator is responsible for ensuring adequate accountability of all used and unused study drug bottles. This includes acknowledgement of receipt of each shipment of study drug (quantity and condition). All used and unused study drug bottles dispensed to subjects must be return... | [] |
NCT02959138 | 5.5.1 | Investigational Medicinal Product Return or Disposal | 5.5.1. Investigational Medicinal Product Return or Disposal Please refer to Section 9.1.7 | [] |
NCT02959138 | 5.6 | Concomitant Medications and Other Protocol Restrictions | 5.6. Concomitant Medications and Other Protocol Restrictions | [] |
NCT02959138 | 5.6.1 | Concomitant Medications | 5.6.1. Concomitant Medications | [] |
NCT02959138 | 5.6.1.1 | Subjects with Normal Renal Function | 5.6.1.1. Subjects with Normal Renal Function The following medications are excluded while subjects are participating in the study (from screening until discharge). This list does not include medications such as anti-HIV agents that would be contraindicated for other exclusion criteria. - Any prescription medications an... | [] |
NCT02959138 | 5.6.1.2 | Subjects with Renal Impairment | 5.6.1.2. Subjects with Renal Impairment Concomitant use of certain medications or herbal/natural supplements with study drug may result in PK interactions resulting in increases or decreases in exposure of study drug or these medications. Concomitant medications taken within 30 days of Screening through the follow-up v... | [] |
NCT02959138 | 5.6.2 | Other Protocol Restrictions | 5.6.2. Other Protocol Restrictions - Subjects will be required to refrain from the consumption of food and beverages containing alcohol products 72 hours prior to the first dose of study drug and during the course of the study through the follow-up visit. - Subjects must be able to comply with the smoking restrictions ... | [] |
NCT02959138 | 6 | STUDY ASSESSMENTS | 6. STUDY ASSESSMENTS The study procedures to be conducted for each subject enrolled in the study are detailed below. Any deviation from protocol procedures should be noted in the subject's clinical chart and appropriate electronic case report forms (eCRFs). In addition, the sponsor should be promptly notified of any pr... | [] |
NCT02959138 | 6.1 | Subject Enrollment and Treatment Assignment | 6.1. Subject Enrollment and Treatment Assignment It is the responsibility of the investigator to ensure that subjects are eligible to participate in the study prior to enrollment and continue to remain eligible throughout the study. Once the ICF has been obtained, all screening and admission tests and assessments have ... | [] |
NCT02959138 | 6.2 | Pretreatment Assessments | 6.2. Pretreatment Assessments | [] |
NCT02959138 | 6.2.1 | Screening Visit | 6.2.1. Screening Visit Prospective subjects should be screened no more than 28 days prior to administration of the first dose of study drug. If a subject does not begin the treatment phase within this 28-day window, all screening evaluation procedures must be repeated. Screening laboratory assessments may be repeated o... | [] |
NCT02959138 | 6.2.2 | Admission Assessments | 6.2.2. Admission Assessments | [] |
NCT02959138 | 6.2.2.1 | Admission | 6.2.2.1. Admission Subjects should be instructed to fast (no food or drink, except water), starting from midnight (00:00) or earlier, as appropriate, on the evening prior to the screening visit to ensure an approximate 8-hour fast prior to the fasted blood sample collection. Subjects meeting all eligibility criteria fo... | [] |
NCT02959138 | 6.2.2.2 | Clinic Confinement | 6.2.2.2. Clinic Confinement Clinic confinement is outlined in Section 3.3, as well as in Table 6-1. | [] |
NCT02959138 | 6.3 | Check-in Assessments | 6.3. Check-in Assessments Following completion of screening and Day -1 assessments, eligible subjects will be assigned a subject number and receive study treatments as shown in Section 5.3. | [] |
NCT02959138 | 6.4 | Treatment Assessments | 6.4. Treatment Assessments Study procedures and assessments are outlined in Table 6-1. | [] |
NCT02959138 | 6.5 | Posttreatment Assessments | 6.5. Posttreatment Assessments All subjects will return 14 days (Β±1) after last dose of study drug for an in-clinic follow-up visit. Study procedures and assessments are outlined in Table 6-1. | [] |
NCT02959138 | 6.6 | Assessments for Premature Discontinuation from Study | 6.6. Assessments for Premature Discontinuation from Study If a subject discontinues study treatment dosing, for example as a result of an AE, every attempt should be made to keep the subject in the study and continue to perform the required study-related procedures until stabilization per the investigator. If this is n... | [] |
NCT02959138 | 6.7 | Criteria for Discontinuation of Study | 6.7. Criteria for Discontinuation of Study Study confinement may be discontinued in the following instances: - Intercurrent illness that would, in the judgment of the investigator, affect assessments of clinical status to a significant degree - Unacceptable toxicity, as defined in the toxicity management section of the... | [] |
NCT02959138 | 6.8 | Pharmacokinetic Assessments | 6.8. Pharmacokinetic Assessments | [] |
NCT02959138 | 6.8.1 | Plasma PK Collection | 6.8.1. Plasma PK Collection Plasma concentrations of GS-9876 will be determined and PK parameters estimated. Plasma concentrations of GS-9876 metabolites may be determined, if necessary. Intensive PK sampling will occur relative to the morning dose of GS-9876 at the following time points: Intensive PK sampling will occ... | [] |
NCT02959138 | 6.8.2 | Urine Pharmacokinetic Collection | 6.8.2. Urine Pharmacokinetic Collection All urine voided will be collected and pooled relative to dosing of GS-9876 at the following collection intervals: Day 1: Pre-dose void, 0-6, 6-12, 12-24, 24-48, 48-72, 72-96 and 96-120 hours postdose Urine concentrations of GS-9876 and/or metabolites may be determined and PK par... | [] |
NCT02959138 | 6.9 | Safety Assessments | 6.9. Safety Assessments Safety will be evaluated throughout the study. Refer to Table 6-1 for a schedule of assessments. | [] |
NCT02959138 | 6.9.1 | Electrocardiogram Assessment | 6.9.1. Electrocardiogram Assessment Subjects should rest quietly in the supine position for a minimum of 10 minutes prior to each scheduled ECG acquisition and should remain in that position until the recording is complete. There should be no environmental distractions (including TV, radio, video games, and conversatio... | [] |
NCT02959138 | 6.9.2 | Physical Examination | 6.9.2. Physical Examination Physical examinations conducted throughout the study will be a complete physical examination or a symptom-directed physical examination, as outlined in Table 6-1. The complete physical examination conducted at screening will also include the following assessments: - A complete physical exami... | [] |
NCT02959138 | 6.9.3 | Vital Signs | 6.9.3. Vital Signs Vital sign measurements include blood pressure, heart rate, respiration rate, and temperature and should be taken once subjects have been seated or in the supine position for a minimum of 5-10 minutes. Subject position for measurement should be kept consistent throughout the study. Refer to Table 6-1... | [] |
NCT02959138 | 6.9.4 | Body Mass Index | 6.9.4. Body Mass Index Height and weight will be collected at screening for calculation of BMI for inclusion criteria. | [] |
NCT02959138 | 6.9.5 | Clinical Laboratory Tests/Assessments | 6.9.5. Clinical Laboratory Tests/Assessments Blood and urine samples for safety evaluations will be collected throughout the study as outlined in Table 6-1. | [] |
NCT02959138 | 6.9.5.1 | Blood Sampling | 6.9.5.1. Blood Sampling Blood samples will be collected for the following laboratory analyses: Hematology: Hematocrit, hemoglobin, platelet count, red blood cell (RBC) count, white blood cell (WBC) count with differential (absolute and percentage), including lymphocytes, monocytes, neutrophils, eosinophils, basophils, ... | [] |
NCT02959138 | 6.9.5.2 | Urine Samples | 6.9.5.2. Urine Samples Urine samples will be collected for urinalysis and alcohol and drug screen assessments. | [] |
NCT02959138 | 6.9.6 | Creatinine Clearance and Estimated Glomerular Filtration Rate | 6.9.6. Creatinine Clearance and Estimated Glomerular Filtration Rate Weight will be collected at screening and upon admission to calculate creatinine clearance (CLcr) and estimate glomerular filtration rate (eGFR), however CLcr will be used for inclusion criteria. eGFR (mL/min/1.73 m2 ) = 175 Γ (\Scr) -1.154 Γ (Age)-0.... | [] |
NCT02959138 | 6.9.7 | Adverse Events/Concomitant Medications/Protocol Restrictions | 6.9.7. Adverse Events/Concomitant Medications/Protocol Restrictions Evaluation for AEs, review of concomitant medications, and review of protocol restrictions will occur at the times shown in Table 6-1. See Section 7 for more information regarding AEs and Sections 4.3 and 5.6.1 for more information about concomitant me... | [] |
NCT02959138 | 6.10 | Sample Storage | 6.10. Sample Storage PPD | [] |
NCT02959138 | 7 | ADVERSE EVENTS AND TOXICITY MANAGEMENT | 7. ADVERSE EVENTS AND TOXICITY MANAGEMENT | [] |
NCT02959138 | 7.1 | Definitions of Adverse Events, Adverse Reactions, and Serious Adverse Events | 7.1. Definitions of Adverse Events, Adverse Reactions, and Serious Adverse Events | [] |
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