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NCT01138072 · ClinicalTrials.gov registry record · Phase 1
A Drug Interaction Study Between Simvastatin, Atorvastatin, Rosuvastatin, and GSK2248761 in Healthy Subjects.
A Phase 1 study of Infection, Human Immunodeficiency Virus, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 1
- Development phase
- 14
- Enrollment target
- 1
- Study location
NCT01138072: Completed Phase 1 study of Infection, Human Immunodeficiency Virus, sponsored by GlaxoSmithKline.
NCT01138072 is a Phase 1 study of Infection, Human Immunodeficiency Virus that has completed, run by GlaxoSmithKline. The registered enrollment target is 14 participants, below the 147-participant average among 19 other Infection, Human Immunodeficiency Virus trials with a reported enrollment target (90% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01138072, a Phase 1 study of Infection, Human Immunodeficiency Virus, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 14 participants
- Enrollment target
- 1
- Study location
Study Summary
This study is a Phase I, open-label, single-sequence drug interaction study to evaluate the effect of repeated doses of GSK2248761 on the pharmacokinetics of simvastatin, atorvastatin, and rosuvastatin in healthy adult subjects. In this study, approximately 14 subjects will receive single doses of simvastatin, atorvastatin, and rosuvastatin on two occasions, once alone and once following administration of repeated doses of GSK2248761. Safety evaluations and serial PK samples will be collected during each treatment period. A follow-up visit will occur 7-14 days after the last dose of study drug.
Conditions Studied
Interventions
- DRUG Rosuvastatin
- DRUG Simvastatin
- DRUG Atorvastatin
- DRUG GSK2248761
Study Locations (1)
Texas
- GSK Investigational Site - Austin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2010-06 |
| Est. Completion | 2010-08 |
| Phase | Phase 1 |
What the finished NCT01138072 record still lists
NCT01138072 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 14 participants, a relatively small participant target, below the 147-participant average among 19 other Infection, Human Immunodeficiency Virus trials with a reported enrollment target (90% lower).
The record links to 1 condition, with Infection, Human Immunodeficiency Virus appearing as the primary indexed condition, and to 4 interventions - of which Rosuvastatin is the first listed.
NCT01138072 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT01138072 about?
NCT01138072 is a clinical study titled "A Drug Interaction Study Between Simvastatin, Atorvastatin, Rosuvastatin, and GSK2248761 in Healthy Subjects.". This study is a Phase I, open-label, single-sequence drug interaction study to evaluate the effect of repeated doses of GSK2248761 on the pharmacokinetics of simvastatin, atorvastatin, and rosuvastatin in healthy adult subjects. In this study, approximately 14 subjects will receive single doses of s...
What is the current status of trial NCT01138072?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 14 participants. The study started on 2010-06. Estimated completion is 2010-08.
What conditions does trial NCT01138072 study?
This clinical trial studies the following conditions: Infection, Human Immunodeficiency Virus.
What interventions are being tested in trial NCT01138072?
The interventions under investigation include: Rosuvastatin (DRUG), Simvastatin (DRUG), Atorvastatin (DRUG), GSK2248761 (DRUG).
Who is sponsoring clinical trial NCT01138072?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01138072 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
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Where NCT01138072's enrollment target sits among peer trials
14 19th of 19 higher than 1 of 19 other Infection, Human Immunodeficiency Virus trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Infection, Human Immunodeficiency Virus 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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