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NCT01231542 · ClinicalTrials.gov registry record · Phase 1
Phase 1, Open Label, Two Arm, Fixed Sequence Study to Evaluate the Effect of Rifampin and Rifabutin on GSK1349572 Pharmacokinetics in Healthy Male and Female Volunteers
A Phase 1 study, sponsored by ViiV Healthcare.
- Completed
- Registry status
- Phase 1
- Development phase
- 27
- Enrollment target
NCT01231542 is a Phase 1 study that has completed, run by ViiV Healthcare. The registered enrollment target is 27 participants.
The verdict
NCT01231542, a Phase 1 study, has completed, sponsored by ViiV Healthcare.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 27 participants
- Enrollment target
Study Summary
This study will be a phase I, open label, two arm, fixed sequence crossover study to investigate the effect of rifampin and rifabutin on the steady state pharmacokinetics (PK) of GSK1349572 and the safety and tolerability of GSK1349572 and rifamycin co-administration. Subjects enrolled in Arm 1 will receive GSK1349572 50 mg once daily for 7 days, GSK1348572 50 mg twice daily for 7 days, and GSK1349572 50 mg twice daily in combination with rifampin 600 mg once daily for 14 days. Subjects in Arm 2 will receive GSK1349572 50 mg once daily for 7 days and GSK1349572 50 mg once daily in combination with rifabutin 300 mg once daily for 14 days. Serial PK sampling will be completed following the last dose of each treatment. Safety and tolerability will be assessed throughout the study through assessment of adverse events (AEs), and clinical laboratory tests. This study will be conducted at one center in the US with healthy adult male and female subjects.
Interventions
- DRUG Rifampin
- DRUG Rifabutin
- DRUG GSK1349572
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 27 participants |
| Start Date | 2011-05 |
| Est. Completion | 2011-12 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01231542
The ClinicalTrials.gov registry entry for NCT01231542 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 27 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 Rifampin is the first listed.
NCT01231542 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01231542 about?
NCT01231542 is a clinical study titled "Phase 1, Open Label, Two Arm, Fixed Sequence Study to Evaluate the Effect of Rifampin and Rifabutin on GSK1349572 Pharmacokinetics in Healthy Male and Female Volunteers". This study will be a phase I, open label, two arm, fixed sequence crossover study to investigate the effect of rifampin and rifabutin on the steady state pharmacokinetics (PK) of GSK1349572 and the safety and tolerability of GSK1349572 and rifamycin co-administration. Subjects enrolled in Arm 1 will...
What is the current status of trial NCT01231542?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 27 participants. The study started on 2011-05. Estimated completion is 2011-12.
What interventions are being tested in trial NCT01231542?
The interventions under investigation include: Rifampin (DRUG), Rifabutin (DRUG), GSK1349572 (DRUG).
Who is sponsoring clinical trial NCT01231542?
This trial is sponsored by ViiV Healthcare, which has 182 total clinical trials registered on ClinicalTrials.gov.
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