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

PHASE1CompletedINTERVENTIONAL
Enrollment

63

Participants

Timeline

Start Date

February 28, 2015

Primary Completion Date

September 30, 2015

Study Completion Date

September 30, 2015

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

Trial Locations (1)

66211

GSK Investigational Site, Overland Park

Sponsors
All Listed Sponsors
collaborator

Janssen Pharmaceuticals

INDUSTRY

collaborator

GlaxoSmithKline

INDUSTRY

lead

ViiV Healthcare

INDUSTRY