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NCT01802918 · ClinicalTrials.gov registry record · Phase 1
Single Dose Escalation Study of GSK2838232 in Healthy Subjects
A Phase 1 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 1
- Development phase
- 17
- Enrollment target
NCT01802918: Completed Phase 1 study, sponsored by GlaxoSmithKline.
NCT01802918 is a Phase 1 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 17 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (72% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01802918, a Phase 1 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 17 participants
- Enrollment target
Study Summary
GSK2838232 is a novel human immune virus (HIV) maturation inhibitor being developed for the treatment of chronic HIV infection. This study is the first administration of GSK2838232 in humans to establish the initial safety, tolerability, and pharmacokinetic profile following single doses of GSK2838232 and to evaluate the effect of food and ritonavir (RTV) on GSK2838232 in healthy subjects. There will be 2 cohorts in this study. In Cohort 1, approximately 8 healthy subjects will be enrolled (6 active and 2 placebo) at each dose visit. There will be four dosing sessions for each subject with subjects randomized to receive placebo in a random sequence. In Cohort 2, approximately 8 healthy subjects will be enrolled (6 active doses and 2 placebo doses at each dose visit). Cohort 2 will have four dosing sessions for each subject with subjects randomized to receive placebo in a random sequence.
Primary Outcome
AEs will be collected from the start of Study Treatment and until 5 days post last-dose (at follow up).
Interventions
- DRUG Placebo
- DRUG Ritonavir
- DRUG GSK2838232
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17 participants |
| Start Date | 2013-02-18 |
| Est. Completion | 2013-11-21 |
| Phase | Phase 1 |
What the finished NCT01802918 record still lists
NCT01802918 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 17 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (72% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT01802918 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01802918 about?
NCT01802918 is a clinical study titled "Single Dose Escalation Study of GSK2838232 in Healthy Subjects". GSK2838232 is a novel human immune virus (HIV) maturation inhibitor being developed for the treatment of chronic HIV infection. This study is the first administration of GSK2838232 in humans to establish the initial safety, tolerability, and pharmacokinetic profile following single doses of GSK28382...
What is the current status of trial NCT01802918?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 17 participants. The study started on 2013-02-18. Estimated completion is 2013-11-21.
What interventions are being tested in trial NCT01802918?
The interventions under investigation include: Placebo (DRUG), Ritonavir (DRUG), GSK2838232 (DRUG).
Who is sponsoring clinical trial NCT01802918?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01802918's enrollment target sits among peer trials
17 1785th of 2000 higher than 215 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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