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NCT05585307 | 5.4 | Accountability for Study Drug Supplies: Study Drug and SOC ART provided by Sponsor (BVY) | 5.4. Accountability for Study Drug Supplies: Study Drug and SOC ART provided by Sponsor (BVY) Guidance related to accountability, return, and disposal for study drug supplies (study drug [GS-5894 for this study] and SOC ART provided by the sponsor [BVY for this substudy]) is provided in Section 5.4 of the master protoc... | [
"6\\ STUDY PROCEDURES"
] |
NCT05585307 | 6.1 | Instructions for Study Procedures | 6.1. Instructions for Study Procedures | [] |
NCT05585307 | 6.1.1 | Pharmacokinetics | 6.1.1. Pharmacokinetics Blood samples will be collected to detennine GS-5894 PK (and metabolites, if appropriate) in plasma as indicated in Table 1.  | [] |
NCT05585307 | 6.1.2 | Suboptimal Virologic Response | 6.1.2. Suboptimal Virologic Response Management of suboptimal virologic response is described in Section 6.3 .9 .1.3 of the master protocol. | [] |
NCT05585307 | 6.1.2.1 | Management of Virologic Rebound | 6.1.2.1. Management of Virologic Rebound Management ofvirologic rebound is described in Section 6.3.9.1.3 of the master protocol. | [] |
NCT05585307 | 6.1.2.2 | Resistance Analysis at Paiiicipant's Last Visit | 6.1.2.2. Resistance Analysis at Paiiicipant's Last Visit Resistance analysis at the pa1iicipant's last visit is described in Section 6.3.9.1.3 of the master protocol. | [] |
NCT05585307 | 7 | ADVERSE EVENTS AND TOXICITY MANAGEMENT | 7. ADVERSE EVENTS AND TOXICITY MANAGEMENT Adverse events are specified in Section 7 of the master protocol. Information regarding toxicity management that is specific to GS-5894 is described below and included in Appendix 11.2. Pregnancy precautions, definition of female of childbearing potential, and contraceptive req... | [] |
NCT05585307 | 7.1 | Toxicity Management | 7.1. Toxicity Management All clinically significant laboratory toxicities will be managed according to uniform guidelines detailed in Appendix 11.2 and as outlined below. - Grade 3 or 4 clinically significant laboratory abnormalities should be confirmed by repeat testing as soon as possible, and preferably within 3 cal... | [] |
NCT05585307 | 7.1.1 | Grade 1 and 2 Laboratory Abnormalities or Clinical Events | 7.1.1. Grade 1 and 2 Laboratory Abnormalities or Clinical Events Continue study drug at the discretion of the investigator for multiple dose cohorts, as applicable. | [] |
NCT05585307 | 7.1.2 | Grade 3 Laboratory Abnormalities or Clinical Events | 7.1.2. Grade 3 Laboratory Abnormalities or Clinical Events For a Grade 3 clinically significant laboratory abnormality confirmed by repeat testing that is considered to be related to the study drug, the study drug should be withheld in multiple dose cohorts and the medical monitor consulted. | [] |
NCT05585307 | 7.1.3 | Grade 4 Laboratory Abnormalities or Clinical Events | 7.1.3. Grade 4 Laboratory Abnormalities or Clinical Events For a Grade 4 clinical event or clinically significant laboratory abnormality confirmed by repeat testing considered to be related to the study drug, study drug should be permanently discontinued in multiple dose cohorts and the participant managed according to... | [] |
NCT05585307 | 8 | STATISTICAL CONSIDERATIONS | 8. STATISTICAL CONSIDERATIONS Details of statistical methods will be provided in the statistical analysis plan for this substudy, including any deviations from the original statistical analyses planned. Statistical considerations for this substudy are described in Section 8 of the master protocol. | [] |
NCT05585307 | 9 | RESPONSIBILITIES | 9. RESPONSIBILITIES Details regarding responsibilities are specified in Section 9 of the master protocol. | [] |
NCT05585307 | 10 | REFERENCES | 10. REFERENCES - BIKTARVY, Gilead Science Inc. BIKTARVY® bicteoravir 50mo/emtricitabine 20Dmo/ tenofovir alafenamide 25mg tablets, U. S. Prescribinig Information. Revised: February. 2021: - Department of Health and Human Services (DHHS). Guidelines for the Use of Antiretroviral Agents in Adults and Adolescents Living w... | [] |
NCT05585307 | 11 | APPENDICES | 11. APPENDICES | [] |
NCT05585307 | 11.1 | Pregnancy Precautions, Definition of Childbearing Potential, and Contraceptive Requirements | 11.1. Pregnancy Precautions, Definition of Childbearing Potential, and Contraceptive Requirements
1) Definitions
a. Definition of Childbearing Potential For the purposes of this study, a participant assigned female at birth is considered of childbearing potential following the initiation of puberty (Tanner Stage 2) u... | [
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"b. Contraception Requirements for ... |
NCT05585307 | 11.2 | Management of Clinical and Laboratory Adverse Events | 11.2. Management of Clinical and Laboratory Adverse Events  | [] |
NCT05585307 | 11.3 | Investigator Signature Page | 11.3. Investigator Signature Page GILEAD SCIENCES, INC. 333 LAKESIDE DRIVE FOSTER CITY, CA 94404 USA
STUDY ACKNOWLEDGMENT An Umbrella Phase 1b, Open-label, Multi-Cohort Study to Evaluate Safety, Pharmacokinetics, and Antiviral Activity of Novel Antiretrovirals in Participants With HIV-1. 27 September 2022 This protoco... | [
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NCT05636501 | 2 | Introduction | 2 Introduction | [] |
NCT05636501 | 2.1 | Background and Rationale | 2.1 Background and Rationale Polymyalgia Rheumatica (PMR) is one of the most common inflammatory diseases of the elderly [1]. It is characterised by symmetrical pain in the proximal muscles, morning stiffness and raised inflammatory markers. Prednisolone remains a cornerstone in the treatment of PMR [2], even though it... | [
"Perspectives"
] |
NCT05636501 | 2 | 2Aim and Objective(s) | 2.2Aim and Objective(s) The overall aim of this study is to investigate benefits and harms associated with a systematic "treat-totarget" prednisolone taper strategy compared to usual care in newly diagnosed, treatment naïve patients with PMR.
Primary objective: To compare the effect of a treat-to-target taper strategy... | [
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NCT05636501 | 2.2.1 | Hypotheses | 2.2.1 Hypotheses - More patients will be in prednisolone free remission after one and two years in PMR patients receiving a treat-to-target prednisolone taper vs. usual care. - No difference will be seen in changes in PMR-AS after one and two years in PMR patients receiving a treat-to-target prednisolone taper vs. usua... | [] |
NCT05636501 | 2 | 3Trial Design | 2.3Trial Design It is a 1-year open label randomised trial, with a planned 1-year extension. Study population is 120 patients with newly diagnosed treatment naïve PMR. Patients will be randomised to either structured treat-to-target prednisolone taper in a hospital setting according to a standard tapering scheme, or to... | [] |
NCT05636501 | 3 | Methods | 3 Methods | [] |
NCT05636501 | 3.1 | Participants, Interventions and Outcomes | 3.1 Participants, Interventions and Outcomes | [] |
NCT05636501 | 3.1.1 | Study Setting | 3.1.1 Study Setting The study is a multicentre study and patients will be included from rheumatological departments in the Central Denmark Region (Aarhus University Hospital, Silkeborg Regional Hospital, Horsens Regional Hospital, Randers Regional Hospital, and Gødstrup Regional Hospital), Southern Denmark Region (Esbj... | [] |
NCT05636501 | 3.1.2 | Eligibility Criteria | 3.1.2 Eligibility Criteria
Inclusion criteria - Patients newly diagnosed with PMR according to the EULAR criteria for PMR [20]. - No sign of GCA on ultrasonography of the temporal and axillary arteries. - Age over 50 years. - Danish spoken and written language skills sufficient to fill out questionnaires.
Exclusion c... | [
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"Exclusion criteria"
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NCT05636501 | 3.1.3 | Interventions | 3.1.3 Interventions Both groups are diagnosed by a rheumatologist according to the inclusion and exclusion criteria. Hereafter treatment with prednisolone is started with 15 mg as a morning dose according to the standard starting dose advised in national as well as EULAR guidelines [13, 14]. All patients will receive a... | [
"Usual Care",
"Treat-to-target Prednisolone Taper"
] |
NCT05636501 | 3.1.4 | Outcomes | 3.1.4 Outcomes
Primary Outcome Proportion of patients in prednisolone free remission 52 weeks from baseline
Key Secondary Outcomes - Change in prednisolone dose from baseline to week 52 - Proportion of GCA patients diagnosed during the first 52 weeks - Self-reported number of relapses during the first 52 weeks (asses... | [
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NCT05636501 | 3.1.5 | Participant timeline | 3.1.5 Participant timeline Table 3 below presents the study-timeline for all study visits. The group randomised to "Treat-to-target" will have additional telephone consultations and clinical blood samples as described in section 3.1.3. The group randomised to usual care will have additional consultations and clinical b... | [] |
NCT05636501 | 3.1.6 | Sample size and power considerations | 3.1.6 Sample size and power considerations One retrospective study have been conducted in this field, where the control group comprised usual care in a hospital setting [19]. Assuming a 30% points difference (between proportions), an alpha of 0.05, and a good statistical power of 90%, a sample size calculation based on... | [] |
NCT05636501 | 3.1.7 | Recruitment | 3.1.7 Recruitment Patients will be recruited from all departments of rheumatology in the Central Denmark Region (Aarhus University Hospital, Silkeborg Regional Hospital, Horsens Regional Hospital, Randers Regional Hospital, Gødstrup Regional Hospital) as well as Esbjerg Regional Hospital, Vejle Regional Hospital, North... | [] |
NCT05636501 | 3.2 | Assignment of Interventions | 3.2 Assignment of Interventions | [] |
NCT05636501 | 3.2.1 | Allocation Sequence generation | 3.2.1 Allocation Sequence generation Participants will be randomly assigned to either "Usual care" or "Treat-to-target" with a 1:1 allocation as per a computer-generated randomisation schedule stratified by site, using permuted blocks of random sizes between 2-6. The block sizes will not be disclosed, to improve the al... | [] |
NCT05636501 | 3.2.2 | Allocation concealment mechanism | 3.2.2 Allocation concealment mechanism Randomisation will be set via the "Randomisation module" in Research Electronic Data Capture (REDCap) [24]. Allocation concealment will be ensured, as the service will not release the randomisation code until the patient has been recruited into the trial, which takes place after a... | [] |
NCT05636501 | 3.2.3 | Implementation | 3.2.3 Implementation All patients who give consent for participation and who fulfil the inclusion criteria will be randomized. Randomization will be implemented at the first visit after all initial information and examination has occurred. Randomization will be assigned by the attending physician at the study site via ... | [] |
NCT05636501 | 3.2.4 | Blinding | 3.2.4 Blinding This is an open-label study without blinding. | [] |
NCT05636501 | 3.3 | Data collection, management and analysis | 3.3 Data collection, management and analysis | [] |
NCT05636501 | 3.3.1 | Data collection methods | 3.3.1 Data collection methods
Demographics At baseline information regarding sex, age, weight, height, other medication, comorbidity, previous history of shoulder and hip related pain, alcohol and tobacco consumption is obtained.
Physical examination Physical examination including ability to raise arms, swollen and t... | [
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"EULAR criteria for PMR and criteria for remission",
"Vascular ultrasonography",
"Patient reported outcome measures/Questionnaires",
"Prednisolone dosage information",
"DXA",
"Blood samples",
"Routine samples",
"Research samples",
"Practical feasibility"
] |
NCT05636501 | 3.3.2 | Data Management | 3.3.2 Data Management Before informed consent, information from the patient journal concerning symptoms, blood tests, inclusion criteria, and exclusion criteria can be passed from a person designated by the investigator. The information will be passed to an investigator in order to determine if the patient may be suita... | [] |
NCT05636501 | 3.3.3 | Statistical methods | 3.3.3 Statistical methods All 95% confidence intervals and P values will be two sided. We will not apply explicit adjustments for multiplicity, rather we will analyse the key secondary outcomes in a prioritised order (i.e. "gatekeeping procedure"): The analyses of the key secondary outcomes will be performed in sequenc... | [] |
NCT05636501 | 3 | 3Monitoring | 3.3Monitoring | [] |
NCT05636501 | 3.3.1 | Data monitoring | 3.3.1 Data monitoring If questionnaires are left unreported by the study participants a reminder will be send via REDCap to the principal investigator who will then facilitate contact to the participants by phone to ensure all questionnaires are reported. | [] |
NCT05636501 | 3.3.2 | Harms | 3.3.2 Harms Harms are stated below in section 4.1 | [] |
NCT05636501 | 4 | Ethics and dissemination | 4 Ethics and dissemination | [] |
NCT05636501 | 4.1 | Research ethics approval | 4.1 Research ethics approval The study conforms to the Danish law concerning patient confidentiality (Databeskyttelsesloven) and the General Data Protection Regulation (Databeskyttelsesforordningen). Approval will be provided from the Central Denmark Region Committee on Health Research Ethics and the project registered... | [
"Prednisolone treatment",
"DXA scan and osteoporosis prophylaxis",
"Blood samples",
"Ultrasound",
"Protocol amendments"
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NCT05636501 | 4.2 | Consent or assent | 4.2 Consent or assent If the patient decline to participate it will not affect the further treatment of the patient. Information about the trial is given at an already scheduled appointment in the outpatient clinic or hospital ward. All information is provided by an investigator or by a person designated by the investi... | [] |
NCT05636501 | 4.3 | Confidentiality | 4.3 Confidentiality All data including patient information is recorded in Research Electronic Data Capture (REDCap). The law on the processing of personal data is followed. Patients' informed written consent is collected before participation in the study. Patient information is protected in accordance with the Danish l... | [] |
NCT05636501 | 4 | 3Declaration of interests | 4.3Declaration of interests Financial contributors do not influence the study implementation or publication of results. There is a continuous search for funding from other funds. If such funding is granted, an amendment to the protocol will be submitted to The Central Denmark Region Committee on Health Research Ethics.... | [] |
NCT05636501 | 4 | 4Access to data | 4.4Access to data All source data will be accessible for Inspection by the Danish Health and Medicine Authority. Patient data and informed consent forms will be stored for 18 years and then destroyed, fully anonymized, or submitted to the State Archives. The Data protection regulation and the Data Protection Act are co... | [] |
NCT05636501 | 4 | 5Ancillary and post-trial care | 4.5Ancillary and post-trial care The Patient Compensation Association covers patients who against all expectations, should be injured in the study. | [] |
NCT05636501 | 4.7 | Dissemination policy | 4.7 Dissemination policy Positive, negative, and inconclusive results will be published in high-ranking international peer-reviewed journals. The reporting of results will adhere to the CONSORT guidelines for RCT studies [28]. MD Christoffer Søvsø Våben will be the first author on all publications. MD, PhD Kresten Kell... | [] |
NCT05636501 | 5 | References | 5 References - 1. Buttgereit, F., et al., Polymyalgia Rheumatica and Giant Cell Arteritis: A Systematic Review. Jama, 2016. 315(22): p. 2442-58. - 2. Dejaco, C., et al., Current evidence for therapeutic interventions and prognostic factors in polymyalgia rheumatica: a systematic literature review informing the 2015 Eur... | [] |
NCT05673889 | 1 | PROTOCOL SUMMARY | 1. PROTOCOL SUMMARY | [] |
NCT05673889 | 1.1 | Synopsis | 1.1. Synopsis Protocol Title: An Interventional, Phase 1, Open-Label, Fixed Sequence, 2-Period Study to Evaluate the Effect of a Single Oral Dose of ARV-471 (PF-07850327) on the Pharmacokinetics of Dabigatran in Healthy Participants Brief Title: Phase 1 Study to Estimate the Effect of ARV-471 on Dabigatran Pharmacokine... | [
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NCT05673889 | 1.2 | Schema | 1.2. Schema Not applicable. | [] |
NCT05673889 | 1.3 | Schedule of Activities | 1.3. Schedule of Activities The SoA table provides an overview of the protocol visits and procedures. Refer to the [STUDY ASSESSMENTS AND](#page-52-3) [PROCEDURES](#page-52-3) section of the protocol for detailed information on each procedure and assessment required for compliance with the protocol. The investigator ma... | [] |
NCT05673889 | 2 | INTRODUCTION | 2. INTRODUCTION ARV-471 (PF-07850327) is a potent, selective, orally bioavailable PROTAC® small molecule that induces degradation of the ER. ARV-471 is being developed for the treatment of patients with ER+/HER2- BC. | [] |
NCT05673889 | 2.1 | Study Rationale | 2.1. Study Rationale CCI CCI ARV-471 does not show inhibition against P-gp on a assay format up to the maximum soluble concentration of CCI while showing an IC50 of in an CCI assay format at the maximum soluble concentration of CCI The difference between the 2 assay formats is likely due to the CCI of ARV-471 in the bi... | [] |
NCT05673889 | 2.2 | Background | 2.2. Background ARV-471 (PF-07850327) is a potent, selective, orally bioavailable PROTAC® small molecule that induces degradation of the ER. ARV-471 is a hetero-bifunctional PROTAC molecule that simultaneously binds the ER and the cereblon E3 ligase complex, enabling protein-protein interactions between ER and the liga... | [] |
NCT05673889 | 2.2.1 | Nonclinical Pharmacology | 2.2.1. Nonclinical Pharmacology CCI CCI CCI CCI CCI CCI CCI In a panel of ER+ cell lines, ARV-471 treatment resulted inCCI decreases in ER levels, similar to those observed with fulvestrant. In cells, ARV-471 achieved a DC50 of with a maximum ER degradation of . In addition to ARV-471, its epimer, ARV-473, was assessed... | [] |
NCT05673889 | 2.2.2 | Nonclinical Pharmacokinetics and Metabolism | 2.2.2. Nonclinical Pharmacokinetics and Metabolism  A CYP reaction phenotyping study was conducted using two orthogonal methods in human liver microsomes and recombinant CYP isoforms that are consistent with current FDA guidance[.1](#page-99-1) This study indicated CYP3A4 as the CCI isoform respo... | [] |
NCT05673889 | 2.2.3 | Nonclinical Safety | 2.2.3. Nonclinical Safety A high-level review of key nonclinical safety data is summarized below, additional information can be found in the investigator's brochure and [Appendix 9.](#page-98-0)   Nonclinical toxicology studies were conducted with ARV-471 to evaluate the p... | [] |
NCT05673889 | 2.2.4 | Clinical Overview | 2.2.4. Clinical Overview In the ongoing FIH study, Study ARV-471-mBC-101, ARV-471 is being assessed as a monotherapy and in combination with palbociclib in patients with advanced/metastatic ER+/HER2- BC. The FIH study has 3 parts: Part A is a monotherapy dose escalation, Part B is a monotherapy expansion at two RP2Ds (... | [] |
NCT05673889 | 2.2.4.1 | Summary of ARV-471 Pharmacokinetics in Humans | 2.2.4.1. Summary of ARV-471 Pharmacokinetics in Humans CCI Preliminary PK data from Part A monotherapy dose escalation of Study CCI (as of 06 Jun 2022) are available from dose levels ranging from 30 to 700 mg administered either as QD or BID. Preliminary results indicated dose-dependent increases in Cmax and AUCtau for... | [] |
NCT05673889 | 2.3 | Benefit/Risk Assessment | 2.3. Benefit/Risk Assessment ARV-471 alone or in combination with dabigatran etexilate (as mesylate) is not expected to provide any clinical benefit to healthy participants. This study is designed primarily to generate safety, tolerability, and pharmacokinetic data for further clinical development. More detailed inform... | [] |
NCT05673889 | 2.3.1 | Risk Assessment | 2.3.1. Risk Assessment | Potential Risk ofClinicalSignificance | SummaryofData/RationaleforRisk | MitigationStrategy | | | | |-----------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------... | [] |
NCT05673889 | 2.3.2 | Benefit Assessment | 2.3.2. Benefit Assessment ARV-471 alone or in combination with dabigatran etexilate (as mesylate) will not provide any clinical benefit to healthy participants in this study. Any anticipated benefit to participants would be in terms of contribution to the process of developing a new therapy for the treatment of ER+/HER... | [] |
NCT05673889 | 2.3.3 | Overall Benefit/Risk Conclusion | 2.3.3. Overall Benefit/Risk Conclusion ARV-471 alone or in combination with dabigatran etexilate (as mesylate) are not expected to provide any clinical benefit to healthy participants in this study. Taking into account the measures to minimize risk to study participants, the potential risks identified in association wi... | [] |
NCT05673889 | 3 | OBJECTIVES AND ENDPOINTS | 3. OBJECTIVES AND ENDPOINTS | Objectives | Endpoints | | | | |---------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------... | [] |
NCT05673889 | 4 | STUDY DESIGN | 4. STUDY DESIGN | [] |
NCT05673889 | 4.1 | Overall Design | 4.1. Overall Design This will be a Phase 1, open-label, 2-period, fixed sequence study to estimate the effect of a single oral ARV-471 dose on the PK of a P-gp substrate, dabigatran etexilate (as mesylate), in healthy male participants or healthy female participants of nonchildbearing potential. An attempt will be made... | [] |
NCT05673889 | 4.2 | Scientific Rationale for Study Design | 4.2. Scientific Rationale for Study Design | [] |
NCT05673889 | 4.2.1 | Probe P-gp Substrate Selection | 4.2.1. Probe P-gp Substrate Selection Dabigatran etexilate (as mesylate) will be used as the P-gp probe substrate in this study. Dabigatran etexilate (as mesylate) is a small molecule prodrug with low systemic exposure that is rapidly absorbed and converted to dabigatran (active form) upon administration via CES hydrol... | [] |
NCT05673889 | 4.2.2 | Administration of Study Interventions With Food | 4.2.2. Administration of Study Interventions With Food CCI is a Phase 1, multi-part, open-label study to evaluate the effect of food or a PPI and to evaluate the relative bioavailability of different tablet formulations on the single 200 mg dose pharmacokinetics and safety of ARV-471 in healthy participants.  | [] |
NCT05673889 | 4.2.4 | Inclusion of Male Participants | 4.2.4. Inclusion of Male Participants Nonclinical toxicology studies are reviewed in Section [2.2.3](#page-23-0) and the most recent IB is included for reference.  CCI Table 4. Exposure Margin Determination for in Rat and Dog Toxicity Studies | Species | Duration ofARV-471administration | No effe... | [] |
NCT05673889 | 4.2.5 | Choice of Contraception/Barrier Requirements | 4.2.5. Choice of Contraception/Barrier Requirements | ARV-471 is known toCCI | in | |----------------------------------------|-------------------------------| | humans or suspected on the basis ofCCI | . Therefore, the use of a CCI | | | (seeAppendix 4). | | [] |
NCT05673889 | 4.2.5.1 | Females – Non-Childbearing Potential | 4.2.5.1. Females – Non-Childbearing Potential Female participants of childbearing potential will not be allowed in this study. Female participants of non-childbearing potential must meet at least one of the criteria defined in Section [5.1](#page-38-2) (all other female participants, including females with tubal ligati... | [] |
NCT05673889 | 4.2.5.2 | Males | 4.2.5.2. Males All fertile male participants who are, in the opinion of the investigator, sexually active and at risk for pregnancy with their partner(s) must agree to use a highly effective method of contraception consistently and correctly for the duration of the active treatment period and continue for at least 90 d... | [] |
NCT05673889 | 4.2.6 | Collection of Retained Research Samples | 4.2.6. Collection of Retained Research Samples Retained Research Samples will be collected and stored for further analyses which may, for example, provide greater understanding of the study intervention. | [] |
NCT05673889 | 4.3 | Justification for Dose | 4.3. Justification for Dose A dose of 200 mg ARV-471 administered as a single dose will be used in this study. This is the current, proposed Phase 3 dose of ARV-471. A single oral dose of 75 mg dabigatran etexilate (as mesylate) will be used in this study. In participants with ER+/HER2- mBC, multiple daily doses up to ... | [] |
NCT05673889 | 4.4 | End of Study Definition | 4.4. End of Study Definition The end of the study is defined as the date of last scheduled procedure shown in the [SoA](#page-16-0) for the last participant in the trial. A participant is considered to have completed the study if they have completed all periods of the study, including the last scheduled procedure shown... | [] |
NCT05673889 | 5 | STUDY POPULATION | 5. STUDY POPULATION This study can fulfill its objectives only if appropriate participants are enrolled, including participants across diverse and representative racial and ethnic backgrounds. Use of a prescreening tool is utilized for study recruitment purposes, it will include collection of information that reflects ... | [] |
NCT05673889 | 5.1 | Inclusion Criteria | 5.1. Inclusion Criteria Participant eligibility should be reviewed and documented by an appropriate member of the investigator's study team before participants are included in the study. Participants are eligible to be included in the study only if all of the following criteria apply:
Age and Sex: - 1. Healthy male an... | [
"Age and Sex:",
"Other Inclusion Criteria:"
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NCT05673889 | 5.2 | Exclusion Criteria | 5.2. Exclusion Criteria Participants are excluded from the study if any of the following criteria apply:
Medical Conditions: - 1. Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (includin... | [
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"Prior/Concomitant Therapy:",
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NCT05673889 | 5.3 | Lifestyle Considerations | 5.3. Lifestyle Considerations The following guidelines are provided: | [] |
NCT05673889 | 5.3.1 | Contraception | 5.3.1. Contraception The investigator or their designee, in consultation with the participant, will confirm that the participant is utilizing an appropriate method of contraception for the individual participant and their partner(s) from the permitted list of contraception methods (see [Appendix 4,](#page-88-0) [Sectio... | [] |
NCT05673889 | 5.3.2 | Meals and Dietary Restrictions | 5.3.2. Meals and Dietary Restrictions - Participants must abstain from all food and drink (except water) at least 4 hours prior to any safety laboratory evaluations and 10 hours prior to the standard breakfast (approximately CCI with a fat content of approximately CCI on Period 1 Day 1 and Period 2 Day 1. Participants ... | [] |
NCT05673889 | 5.3.3 | Caffeine, Alcohol, and Tobacco | 5.3.3. Caffeine, Alcohol, and Tobacco - Participants will abstain from caffeine-containing products for 24 hours prior to the start of dosing until collection of the final PK sample of each study period. - Participants will abstain from alcohol for 24 hours prior to admission to the CRU and continue abstaining from alc... | [] |
NCT05673889 | 5.3.4 | Activity | 5.3.4. Activity - Participants will abstain from strenuous exercise (eg, heavy lifting, weight training, calisthenics, aerobics) for at least 48 hours prior to each blood collection for clinical laboratory tests. Walking at a normal pace will be permitted. - In order to standardize the conditions on PK sampling days, p... | [] |
NCT05673889 | 5.4 | Screen Failures | 5.4. Screen Failures Screen failures are defined as participants who consent to participate in the clinical study but are not subsequently enrolled in the study. Screen failure data are collected and remain as source and are not reported on the CRF. Individuals who do not meet the criteria for participation in this stu... | [] |
NCT05673889 | 6 | STUDY INTERVENTION(S) AND CONCOMITANT THERAPY | 6. STUDY INTERVENTION(S) AND CONCOMITANT THERAPY Study interventions are all prespecified investigational and non-investigational medicinal products/auxiliary medicinal products, medical devices, and other interventions (eg, surgical and behavioral) intended to be administered to the study participants during the study... | [] |
NCT05673889 | 6.1 | Study Intervention(s) Administered | 6.1. Study Intervention(s) Administered | | StudyIntervention(s) | | |---------------------------------------------------------------------------------------------|--------------------------|--------------------------------------------------| | Intervention Name | ARV-471 (PF-07850327) | Dabigatran etexilate (as mesyla... | [] |
NCT05673889 | 6.1.1 | Administration | 6.1.1. Administration Period 1 Day 1: Following an overnight fast of at least 10 hours, participants will start the recommended standard breakfast approximately 2 hours (120 minutes) prior to dabigatran etexilate (as mesylate) (as 1 capsule of 75 mg) dosing. The standard breakfast will be required to be completely cons... | [] |
NCT05673889 | 6.2 | Preparation, Handling, Storage, and Accountability | 6.2. Preparation, Handling, Storage, and Accountability - 1. The investigator or designee must confirm that appropriate conditions (eg, temperature) have been maintained during transit for all study interventions received and any discrepancies are reported and resolved before use of the study intervention. - 2. Only pa... | [] |
NCT05673889 | 6.2.1 | Preparation and Dispensing | 6.2.1. Preparation and Dispensing Within this protocol, preparation refers to the investigator site activities performed to make the study intervention ready for administration or dispensing to the participant by qualified staff. Dispensing is defined as the provision of study intervention, concomitant treatments, and ... | [] |
NCT05673889 | 6.3 | Assignment to Study Intervention | 6.3. Assignment to Study Intervention The investigator's knowledge of the treatment should not influence the decision to enroll a particular participant or affect the order in which participants are enrolled. The investigator will assign participant numbers to the participants as they are screened for the study. Pfizer... | [] |
NCT05673889 | 6.4 | Blinding | 6.4. Blinding This is an open-label study. | [] |
NCT05673889 | 6.4.1 | Blinding of Participants | 6.4.1. Blinding of Participants Participants will be unblinded to their assigned study intervention. | [] |
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