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NCT02373930 · ClinicalTrials.gov registry record · Phase 1
Relative Oral Bioavailability Study of Different Fixed Dose Combinations of Dolutegravir and Rilpivirine in Healthy Subjects
A Phase 1 study, sponsored by ViiV Healthcare.
- Completed
- Registry status
- Phase 1
- Development phase
- 63
- Enrollment target
NCT02373930 is a Phase 1 study that has completed, run by ViiV Healthcare. The registered enrollment target is 63 participants.
The verdict
NCT02373930, a Phase 1 study, has completed, sponsored by ViiV Healthcare.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 63 participants
- Enrollment target
Study Summary
Treatment of human immunodeficiency virus (HIV) infection requires daily oral administration of a combination of antiretroviral drugs to reduce the patient's HIV levels. Dolutegravir (DTG), a HIV-1 integrase inhibitor (INI), and Rilpivirine (RPV), a non-nucleoside HIV-1 reverse transcriptase inhibitor (NNRTI), are approved for the treatment of HIV infection. This study is aimed to evaluate the relative bioavailability and food effect of single doses of several experimental fixed dose combination (FDC) tablets of Dolutegravir 50 milligrams (mg) and Rilpivirine 25 mg (DTG/RPV 50 mg/25 mg) relative to co-administration of a single dose of the reference single entity products (DTG 50 mg and RPV 25 mg) in healthy adult subjects. This is a 2-part study. Part 1 will be conducted as a randomized, open label, 3-way, crossover design in 24 subjects. Part 1 will evaluate the relative bioavailability of up to 4 test formulations relative to the reference single entity products administered in fed state. Part 2 will be conducted as a randomized, open-label, 3-way crossover design in 3 distinct cohorts each with 12 subjects. Part 2 will evaluate the relative bioavailability of up to 3 most promising FDC formulation selected from Part 1 (DTG/RPV FDC-1, DTG/RPV FDC-2, DTG/RPV FDC-3) administered in fasted and fed state. Subjects will also receive the reference treatment from Part 1 co-administered under fasted conditions. This study will consist of a screening visit, three treatment periods each with a single dose of study drug separated by a washout of at least 9 days and a follow-up visit. The total duration of participation of a subject in this study will be approximately 10 weeks.
Interventions
- DRUG DTG 50 mg
- DRUG RPV 25 mg
- DRUG DTG/RPV 50 mg/25 mg: Product Code AS
- DRUG DTG/RPV 50 mg/25 mg: Product Code AM
- DRUG DTG/RPV 50 mg/25 mg: Product Code AQ
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 63 participants |
| Start Date | 2015-02 |
| Est. Completion | 2015-09 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02373930
The ClinicalTrials.gov registry entry for NCT02373930 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 63 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 5 interventions - of which DTG 50 mg is the first listed.
NCT02373930 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02373930 about?
NCT02373930 is a clinical study titled "Relative Oral Bioavailability Study of Different Fixed Dose Combinations of Dolutegravir and Rilpivirine in Healthy Subjects". Treatment of human immunodeficiency virus (HIV) infection requires daily oral administration of a combination of antiretroviral drugs to reduce the patient's HIV levels. Dolutegravir (DTG), a HIV-1 integrase inhibitor (INI), and Rilpivirine (RPV), a non-nucleoside HIV-1 reverse transcriptase inhibit...
What is the current status of trial NCT02373930?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 63 participants. The study started on 2015-02. Estimated completion is 2015-09.
What interventions are being tested in trial NCT02373930?
The interventions under investigation include: DTG 50 mg (DRUG), RPV 25 mg (DRUG), DTG/RPV 50 mg/25 mg: Product Code AS (DRUG), DTG/RPV 50 mg/25 mg: Product Code AM (DRUG), DTG/RPV 50 mg/25 mg: Product Code AQ (DRUG).
Who is sponsoring clinical trial NCT02373930?
This trial is sponsored by ViiV Healthcare, which has 182 total clinical trials registered on ClinicalTrials.gov.
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