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

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

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

Sponsors & Collaborators

• Janssen Pharmaceuticals

  collaborator INDUSTRY

• GlaxoSmithKline

  collaborator INDUSTRY

• ViiV Healthcare

  lead INDUSTRY

Principal Investigators

• GSK Clinical Trials · ViiV Healthcare

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2015-02-28

Primary Completion

2015-09-30

Completion

2015-09-30

Countries

• United States

Study Locations