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NCT03984812 · ClinicalTrials.gov registry record · Phase 1
Evaluation of the Safety, Tolerability and Pharmacokinetics (PK) of GSK3732394 First-Time-in-Human (FTIH) Study
A Phase 1 study, sponsored by ViiV Healthcare.
- Terminated
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
NCT03984812: Clinical Trial Phase 1 study, sponsored by ViiV Healthcare.
NCT03984812 is a Phase 1 study that was terminated before completion, run by ViiV Healthcare. The registered enrollment target is 24 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03984812, a Phase 1 study, was terminated before completion, sponsored by ViiV Healthcare.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
Study Summary
This is a phase 1, 2-part, double-blind (sponsor-unblinded), randomized, placebo-controlled, FTIH study, that includes both single-ascending and multiple-ascending dose phase to assess the safety, tolerability, and pharmacokinetic (PK)/pharmacodynamic (PD) attributes of GSK3732394 in healthy subjects. The data gathered in this study will further enable clinical development of GSK3732394 in HIV-infected subjects. Approximately 72 healthy subjects will be randomized in the FTIH study. Part 1 will be the single ascending dose (SAD) phase and Part 2 will be the multiple ascending dose (MAD) phase. Each subject in the SAD cohort will receive a single dose of blinded GSK3732394 or blinded placebo (PBO) in 6:2 ratio. Part 1 will consist of five ascending single-dose cohorts with an additional expansion cohort included as needed. Part 2 will consist of up to three ascending repeat-dose cohorts (MAD Cohorts 1, 2, and 3), randomized to four weekly doses of blinded GSK3732394 or blinded PBO in 6:2 ratio to be administered on Days 1, 8, 15, and 22.
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. A SAE is defined as any untoward medical occurrence that, at any dose: results in death and is life-threatening which requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability or incapacity and birth defect or congenital anomaly, or any other situati
Interventions
- DRUG Placebo
- DRUG GSK3732394
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2019-06-17 |
| Est. Completion | 2020-03-23 |
| Phase | Phase 1 |
Why NCT03984812 stopped before completion
NCT03984812 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03984812 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03984812 about?
NCT03984812 is a clinical study titled "Evaluation of the Safety, Tolerability and Pharmacokinetics (PK) of GSK3732394 First-Time-in-Human (FTIH) Study". This is a phase 1, 2-part, double-blind (sponsor-unblinded), randomized, placebo-controlled, FTIH study, that includes both single-ascending and multiple-ascending dose phase to assess the safety, tolerability, and pharmacokinetic (PK)/pharmacodynamic (PD) attributes of GSK3732394 in healthy subject...
What is the current status of trial NCT03984812?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2019-06-17. Estimated completion is 2020-03-23.
What interventions are being tested in trial NCT03984812?
The interventions under investigation include: Placebo (DRUG), GSK3732394 (DRUG).
Who is sponsoring clinical trial NCT03984812?
This trial is sponsored by ViiV Healthcare, which has 182 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03984812's enrollment target sits among peer trials
24 1520th of 2000 higher than 405 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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