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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 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.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04563845
The ClinicalTrials.gov registry entry for NCT04563845 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (89% lower). The listed sponsor is ViiV Healthcare, which has 182 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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