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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 is a Phase 1 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 17 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01802918
The ClinicalTrials.gov registry entry for NCT01802918 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 17 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is GlaxoSmithKline, which has 1,345 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT01802918 reports 0 study locations.
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.
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