GSK1349572 Exposure in Blood, Seminal Fluid, and Rectal Fluid and Tissue in Healthy Male Subjects

PHASE1CompletedINTERVENTIONAL
Enrollment

14

Participants

Timeline

Start Date

November 30, 2011

Primary Completion Date

November 30, 2012

Study Completion Date

December 31, 2012

Conditions
Healthy
Interventions
DRUG

dolutegravir

Subjects will take a GSK1349572 (dolutegravir) 50mg tablet by mouth once daily for 8 days. GSK1349572 concentrations will be measured in blood plasma, seminal fluid, rectal fluid, and rectal tissue over 24 hours after a single dose and over two 24 hour periods once steady state is reached. Blood plasma will be collected pre-dose and 1, 2, 3, 4, 5, 6, 8, 12, 18, and 24 hours after dosing. Each subject will also provide a total of 9 seminal and rectal fluid samples and have 2 rectal tissue biopsies performed pre-dose or at 1, 3, 6, 12, 18, or 24 hours after receiving single or multiple doses.

Trial Locations (1)

27599

University of North Carolina, Chapel Hill, Chapel Hill

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

GlaxoSmithKline

INDUSTRY

lead

University of North Carolina, Chapel Hill

OTHER

NCT01459315 - GSK1349572 Exposure in Blood, Seminal Fluid, and Rectal Fluid and Tissue in Healthy Male Subjects | Biotech Hunter | Biotech Hunter