TMC278-TiDP15-C158 - A Study to Examine the Safety, Tolerability and Pharmacokinetics of a Single Dose or Three Successive Doses of Intramuscularly (IM) Injected Long Acting Formulation of TMC278

• Status: Completed
• Trial end date: 2011-07-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to examine the safety, local tolerability and pharmacokinetics (how drugs are absorbed in the body, how they are distributed within the body and how they are removed from the body over time) of a single intramuscular injection (injected directly in the muscle) of 300 mg (Panel 1) or 600 mg (Panel 2) of a new long acting form of TMC278. In Panel 3, the safety, local tolerability and pharmacokinetics are being studied after three successive intramuscular injections (single injection on Day1, single injection on Day15 and single injection on Day43) of a selected dose of the same TMC278 LA formulation. The dose of Panel 3 will be determined based on the safety, local tolerability and the pharmacokinetic results obtained in Panel 1 and 2.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Tibotec Pharmaceuticals, Ireland
• Treatments: Rilpivirine

Criteria

Inclusion Criteria:

• Non-smoker for at least 3 months prior to selection

• A BMI of 18.0 to 30.0 kg/m2

• Normal 12-lead electrocardiogram

• Healthy on the basis of physical examination, clinical laboratory tests, medical history and vital signs

Exclusion Criteria:

• Female, except if postmenopausal for at least 2 years or surgically sterile

• positive urine drug test

• History of clinically relevant skin disease or drug allergy

• Participation in an investigational drug study or having received a vaccine within 30 days prior to the first injection of TMC278 LA or placebo

• Previous participation in a study with oral TMC278, TMC125, TMC120 and/or TMC278 LA