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NCT01101893 · ClinicalTrials.gov registry record · Phase 1
A Drug Interaction Study Evaluating GSK2248761 and Raltegravir Pharmacokinetics in Healthy Adult Subjects
A Phase 1 study, sponsored by ViiV Healthcare.
- Completed
- Registry status
- Phase 1
- Development phase
- 15
- Enrollment target
NCT01101893 is a Phase 1 study that has completed, run by ViiV Healthcare. The registered enrollment target is 15 participants.
The verdict
NCT01101893, a Phase 1 study, has completed, sponsored by ViiV Healthcare.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 15 participants
- Enrollment target
Study Summary
In this study, approximately 16 subjects will receive raltegravir 400mg twice daily for 5 days (Treatment A) followed by a washout period. In Period 2, subjects will receive GSK2248761 200mg once daily for 5 days (Treatment B). There will be no wash out between Period 2 and 3. Subjects will then be administered raltegravir 400mg twice daily in combination with GSK2248761 200mg once daily (Treatment C) for 5 days. Subjects will be housed in the unit for the duration of the study. 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.
Interventions
- DRUG Raltegravir
- DRUG GSK2248761
- DRUG GSK2248761 + Raltegravir
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2010-04 |
| Est. Completion | 2010-06 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01101893
The ClinicalTrials.gov registry entry for NCT01101893 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 15 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is ViiV Healthcare, which has 182 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Raltegravir is the first listed.
NCT01101893 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01101893 about?
NCT01101893 is a clinical study titled "A Drug Interaction Study Evaluating GSK2248761 and Raltegravir Pharmacokinetics in Healthy Adult Subjects". In this study, approximately 16 subjects will receive raltegravir 400mg twice daily for 5 days (Treatment A) followed by a washout period. In Period 2, subjects will receive GSK2248761 200mg once daily for 5 days (Treatment B). There will be no wash out between Period 2 and 3. Subjects will then be ...
What is the current status of trial NCT01101893?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 15 participants. The study started on 2010-04. Estimated completion is 2010-06.
What interventions are being tested in trial NCT01101893?
The interventions under investigation include: Raltegravir (DRUG), GSK2248761 (DRUG), GSK2248761 + Raltegravir (DRUG).
Who is sponsoring clinical trial NCT01101893?
This trial is sponsored by ViiV Healthcare, which has 182 total clinical trials registered on ClinicalTrials.gov.
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