A Study to Evaluate Safety, Acceptability, Pharmacokinetics, and ex Vivo Pharmacodynamics of TMC278 Long Acting Formulation in HIV-1 Seronegative Participants

PHASE1CompletedINTERVENTIONAL
Enrollment

4

Participants

Timeline

Start Date

November 30, 2012

Primary Completion Date

January 31, 2016

Study Completion Date

January 31, 2016

Conditions
Healthy
Interventions
DRUG

TMC278, Long acting (LA)

TMC278 long acting will be administered IM to the participants as follows: a single dose of TMC278 600 mg will be administered at baseline in Arm 2A and Arm 2B; at Months 2 and 4 in Arm 5A and Arm 5B. A single dose of TMC278 900 mg will be administered at Months 2 and 4 in Arm 4A and Arm 4B. A single dose of TMC278 1200 mg will be administered at baseline in Arm 1A, Arm 1B; Arm 3A, Arm 3B, Arm 4A, Arm 4B, Arm 5A and Arm 5B; at Months 2 and 4 in Arm 3A and Arm 3B.

Trial Locations (1)

Unknown

Pittsburgh

All Listed Sponsors
lead

Janssen Research & Development, LLC

INDUSTRY

NCT01656018 - A Study to Evaluate Safety, Acceptability, Pharmacokinetics, and ex Vivo Pharmacodynamics of TMC278 Long Acting Formulation in HIV-1 Seronegative Participants | Biotech Hunter | Biotech Hunter