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NCT02027454 · ClinicalTrials.gov registry record · Phase 1
Study to Evaluate the Effect of GSK1265744 on Cardiac Conduction
A Phase 1 study of Infection, Human Immunodeficiency Virus, sponsored by ViiV Healthcare.
- Completed
- Registry status
- Phase 1
- Development phase
- 42
- Enrollment target
- 1
- Study location
NCT02027454: Completed Phase 1 study of Infection, Human Immunodeficiency Virus, sponsored by ViiV Healthcare.
NCT02027454 is a Phase 1 study of Infection, Human Immunodeficiency Virus that has completed, run by ViiV Healthcare. The registered enrollment target is 42 participants, below the 145-participant average among 19 other Infection, Human Immunodeficiency Virus trials with a reported enrollment target (71% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02027454, a Phase 1 study of Infection, Human Immunodeficiency Virus, has completed, sponsored by ViiV Healthcare.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 42 participants
- Enrollment target
- 1
- Study location
Study Summary
This study is being conducted to comply with the Food and Drug Administration (FDA) recommendation that all new non anti-arrhythmic drugs be assessed for cardiac repolarization effects through electrocardiographic evaluation. Therefore, this study will evaluate the effect of GSK1265744 on cardiac conduction as assessed by collection of twelve-lead continuous digital data in healthy adults. This study will evaluate the effect of three doses of GSK1265744 on the QT duration corrected for heart rate (QTc) interval as compared to placebo. Moxifloxacin will be used as a positive control in order to validate the sensitivity of the study in detecting QTc change. This study consists of three treatment periods (each separated by 21 day washout period) followed by follow-up visit 10 to 14 days post last dosing. The total duration of study including follow-up visit will be approximately 62 days. Approximately 42 subjects will be enrolled such that 34 subjects complete dosing and critical assessments.
Primary Outcome
QT interval is a measure of the time between the start of the Q wave and the end of the T wave in the heart's electrical cycle. QTcF interval will be obtained by digital electrocardiograms (ECG) obtained through 12 lead holter monitoring machine. Triplicate ECGs will be evaluated at each time point
Conditions Studied
Interventions
- DRUG Moxifloxacin
- DRUG GSK1265744
- DRUG GSK1265744 matching placebo
Study Locations (1)
Kansas
- GSK Investigational Site - Overland Park
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 42 participants |
| Start Date | 2014-01 |
| Est. Completion | 2014-06 |
| Phase | Phase 1 |
What the finished NCT02027454 record still lists
NCT02027454 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 42 participants, a relatively small participant target, below the 145-participant average among 19 other Infection, Human Immunodeficiency Virus trials with a reported enrollment target (71% lower).
The record links to 1 condition, with Infection, Human Immunodeficiency Virus appearing as the primary indexed condition, and to 3 interventions - of which Moxifloxacin is the first listed.
NCT02027454 reports a single indexed study location in Kansas.
Frequently Asked Questions
What is clinical trial NCT02027454 about?
NCT02027454 is a clinical study titled "Study to Evaluate the Effect of GSK1265744 on Cardiac Conduction". This study is being conducted to comply with the Food and Drug Administration (FDA) recommendation that all new non anti-arrhythmic drugs be assessed for cardiac repolarization effects through electrocardiographic evaluation. Therefore, this study will evaluate the effect of GSK1265744 on cardiac co...
What is the current status of trial NCT02027454?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 42 participants. The study started on 2014-01. Estimated completion is 2014-06.
What conditions does trial NCT02027454 study?
This clinical trial studies the following conditions: Infection, Human Immunodeficiency Virus.
What interventions are being tested in trial NCT02027454?
The interventions under investigation include: Moxifloxacin (DRUG), GSK1265744 (DRUG), GSK1265744 matching placebo (DRUG).
Who is sponsoring clinical trial NCT02027454?
This trial is sponsored by ViiV Healthcare, which has 182 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02027454 being conducted?
This trial has 1 study location across Kansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02027454's enrollment target sits among peer trials
42 11th of 19 higher than 9 of 19 other Infection, Human Immunodeficiency Virus trials
participants (enrollment target), bucketed by value
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