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NCT04493684 · ClinicalTrials.gov registry record · Phase 1
GSK3739937 First-Time-In-Human (FTIH) Study in Healthy Volunteers
A Phase 1 study, sponsored by ViiV Healthcare.
- Completed
- Registry status
- Phase 1
- Development phase
- 91
- Enrollment target
NCT04493684 is a Phase 1 study that has completed, run by ViiV Healthcare. The registered enrollment target is 91 participants.
The verdict
NCT04493684, a Phase 1 study, has completed, sponsored by ViiV Healthcare.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 91 participants
- Enrollment target
Study Summary
This study is a Phase 1, double-blind (sponsor-unblinded), randomized, placebo-controlled, single- and repeat-dose escalation study including a weekly oral dose (MAD) cohort and a relative bioavailability (RBA) and food effect (FE) cohort to investigate the safety, tolerability and PK of VH3739937 in healthy participants. This is a three part study. Part 1 and Part 2 is designed to gain information on the safety, tolerability, and pharmacokinetic (PK) properties of GSK3739937 when administered as powder-in-a-bottle (PiB). Part 3 will evaluate the RBA of the GSK3739937 PiB and GSK3739937 Tablet and the safety, tolerability and PK parameters of the tablet formulation when administered under fasting and fed conditions.
Interventions
- DRUG Placebo
- DRUG GSK3739937 (PIB)
- DRUG GSK3739937 (Tablet)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 91 participants |
| Start Date | 2020-07-31 |
| Est. Completion | 2021-08-30 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04493684
The ClinicalTrials.gov registry entry for NCT04493684 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 91 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is ViiV Healthcare, which has 182 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT04493684 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04493684 about?
NCT04493684 is a clinical study titled "GSK3739937 First-Time-In-Human (FTIH) Study in Healthy Volunteers". This study is a Phase 1, double-blind (sponsor-unblinded), randomized, placebo-controlled, single- and repeat-dose escalation study including a weekly oral dose (MAD) cohort and a relative bioavailability (RBA) and food effect (FE) cohort to investigate the safety, tolerability and PK of VH3739937 i...
What is the current status of trial NCT04493684?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 91 participants. The study started on 2020-07-31. Estimated completion is 2021-08-30.
What interventions are being tested in trial NCT04493684?
The interventions under investigation include: Placebo (DRUG), GSK3739937 (PIB) (DRUG), GSK3739937 (Tablet) (DRUG).
Who is sponsoring clinical trial NCT04493684?
This trial is sponsored by ViiV Healthcare, which has 182 total clinical trials registered on ClinicalTrials.gov.
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