NCT02373930

Relative Oral Bioavailability Study of Different Fixed Dose Combinations of Dolutegravir and Rilpivirine in Healthy Subjects

A Phase I, 2-part Relative Oral Bioavailability Study of Different Fixed Dose Combinations of Dolutegravir and Rilpivirine in Fasted and Fed Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 63 (actual)
• Sponsor: ViiV Healthcare · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Infection, Human Immunodeficiency Virus

Interventions

Type	Name	Description
DRUG	DTG 50 mg	Dolutegravir will be supplied as a white, film-coated, round tablet with a unit dose strength of 50 mg to be administered orally
DRUG	RPV 25 mg	Rilpivirine will be supplied as a white to off-white, film-coated, round biconvex tablet with a unit dose strength of 25 mg to be administered orally
DRUG	DTG/RPV 50 mg/25 mg: Product Code AS	DTG/RPV will be supplied as a pink, film coated, round biconvex tablet with a unit dose strength of 50 mg DTG and 25 mg RPV to be administered orally
DRUG	DTG/RPV 50 mg/25 mg: Product Code AM	DTG/RPV will be supplied as a pink, film coated, oval, biconvex tablet with a unit dose strength of 50 mg DTG and 25 mg RPV to be administered orally
DRUG	DTG/RPV 50 mg/25 mg: Product Code AQ	DTG/RPV will be supplied as a pink, film coated, round, biconvex tablet with a unit dose strength of 50 mg DTG and 25 mg RPV to be administered orally
DRUG	DTG/RPV 50 mg/25 mg: Product Code AK	DTG/RPV will be supplied as pink, film coated, oval, biconvex tablet with a unit dose strength of 50 mg DTG and 25 mg RPV to be administered orally
DRUG	DTG/RPV 50 mg/25 mg: Product Code AR	DTG/RPV will be supplied as a pink, film coated, round, biconvex tablet with a unit dose strength of 50 mg DTG and 25 mg RPV to be administered orally

Timeline

• Start date: 2015-02-01
• Primary completion: 2015-09-01
• Completion: 2015-09-01
• First posted: 2015-02-27
• Last updated: 2016-06-27

Locations

1 site across 1 country: United States