TMC278-TiDP6-C153 - A Study in Healthy Volunteers Investigating the Pharmacokinetic Interaction Between TMC278 and Raltegravir

• Status: Completed
• Trial end date: 2011-05-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to investigate the effect of steady-state concentrations of raltegravir (administered as 400 mg, twice daily) on the steady-state pharmacokinetics of TMC278 (25 mg, once daily), and vice versa. Steady state is a term that means that the drug has been given long enough so that the plasma levels will remain at about the same level with each subsequent dose. TMC278 is being investigated for the treatment of human immunodeficiency virus (HIV) infection. Raltegravir is a commercially available antiretroviral drug for treatment of HIV infection. Pharmacokinetics (PK) means how the drug is absorbed into the bloodstream, distributed in the body and eliminated from the body.

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

Details

• Lead Sponsor: Tibotec Pharmaceuticals, Ireland
• Collaborator: Raltegravir is provided by Merck.
• Treatments: Raltegravir Potassium; Rilpivirine

Criteria

Inclusion Criteria:

• Healthy, based on physical examination, medical history, vital signs, ECG, blood biochemistry, hematology and urinalysis

• Body Mass Index of 18 to 30.0 kg/m2

• Non-smoking for at least 3 months prior to screening

• Women must be postmenopausal for at least 2 years, or be surgically sterile.

Exclusion Criteria:

• Infected with Hepatitis A, B, or C Virus

• Infected with human immunodeficiency virus (HIV)

• History of clinically relevant hearth rhythm disturbances

• Having previously participated in more than 1 study with raltegravir, TMC125, TMC120 and/or TMC278 or having developed rash, erythema or urticaria while participating in a trial with aforementioned compounds