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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 is a Phase 1 study that was terminated before completion, run by ViiV Healthcare. The registered enrollment target is 24 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03984812
The ClinicalTrials.gov registry entry for NCT03984812 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 24 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 2 interventions - of which Placebo is the first listed.
NCT03984812 reports 0 study locations.
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.
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