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NCT04563845 · ClinicalTrials.gov registry record · Phase 1
Effect of Therapeutic and Supratherapeutic Oral Doses of GSK3640254 on Cardiac Conduction Compared to Placebo and a Single Oral Dose of Moxifloxacin
A Phase 1 study of HIV Infections, sponsored by ViiV Healthcare.
- Completed
- Registry status
- Phase 1
- Development phase
- 50
- Enrollment target
- 1
- Study location
NCT04563845: Completed Phase 1 study of HIV Infections, sponsored by ViiV Healthcare.
NCT04563845 is a Phase 1 study of HIV Infections that has completed, run by ViiV Healthcare. The registered enrollment target is 50 participants, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (89% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04563845, a Phase 1 study of HIV Infections, has completed, sponsored by ViiV Healthcare.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 50 participants
- Enrollment target
- 1
- Study location
Study Summary
This study will aim to evaluate the effect of therapeutic and supratherapeutic oral doses of GSK3640254 on cardiac conduction compared to placebo and a single oral dose of Moxifloxacin in healthy adult participants. The study has 2 parts: Part 1 will determine the supratherapeutic dose for Part 2, which will be the main corrected QT interval (QTc) study. Part 1 will evaluate once daily (QD) dosing of GSK3640254 or placebo and Part 2 will investigate the safety, tolerability and Pharmacokinetics (PK) of GSK3640254 doses on cardiac conduction as compared to placebo and a single oral dose of Moxifloxacin in healthy adult participants. Moxifloxacin will be included as a positive control.
Primary Outcome
Blood samples were collected at indicated time points. Pharmacokinetic (PK) analysis was conducted using standard non-compartmental methods.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Moxifloxacin
- DRUG GSK3640254
Study Locations (1)
Texas
- GSK Investigational Site - Austin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2020-11-09 |
| Est. Completion | 2021-10-30 |
| Phase | Phase 1 |
What the finished NCT04563845 record still lists
NCT04563845 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (89% lower).
The record links to 1 condition, with HIV Infections appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT04563845 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT04563845 about?
NCT04563845 is a clinical study titled "Effect of Therapeutic and Supratherapeutic Oral Doses of GSK3640254 on Cardiac Conduction Compared to Placebo and a Single Oral Dose of Moxifloxacin". This study will aim to evaluate the effect of therapeutic and supratherapeutic oral doses of GSK3640254 on cardiac conduction compared to placebo and a single oral dose of Moxifloxacin in healthy adult participants. The study has 2 parts: Part 1 will determine the supratherapeutic dose for Part 2, w...
What is the current status of trial NCT04563845?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 50 participants. The study started on 2020-11-09. Estimated completion is 2021-10-30.
What conditions does trial NCT04563845 study?
This clinical trial studies the following conditions: HIV Infections.
What interventions are being tested in trial NCT04563845?
The interventions under investigation include: Placebo (DRUG), Moxifloxacin (DRUG), GSK3640254 (DRUG).
Who is sponsoring clinical trial NCT04563845?
This trial is sponsored by ViiV Healthcare, which has 182 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04563845 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for HIV Infections
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04563845's enrollment target sits among peer trials
50 355th of 542 higher than 177 of 542 other HIV Infections trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other HIV Infections 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.
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