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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: Completed Phase 1 study, sponsored by ViiV Healthcare.

NCT04493684 is a Phase 1 study that has completed, run by ViiV Healthcare. The registered enrollment target is 91 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (52% higher). According to ClinicalTrials.gov, the official US trial registry.

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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.

Primary Outcome

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An SAE is defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent disability/incapacity; is a congenital anomaly/birth defect and important medical events may

Interventions

  • DRUG Placebo
  • DRUG GSK3739937 (PIB)
  • DRUG GSK3739937 (Tablet)

Trial Details

FieldValue
Enrollment Target 91 participants
Start Date 2020-07-31
Est. Completion 2021-08-30
Phase Phase 1
ViiV Healthcare

182 total trials

What the finished NCT04493684 record still lists

NCT04493684 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 91 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (52% higher).

The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.

NCT04493684 does not publish any study locations in the registry export this page uses.

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.

How this trial's enrollment target compares

Where NCT04493684's enrollment target sits among peer trials

91 626th of 2000 higher than 1,373 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT04493684, the US trial registry maintained by the National Library of Medicine. NCT04493684 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.