A Study to Investigate the Effect of Steady-State TMC278 on the Pharmacokinetics of a Single Dose of Digoxin

• Status: Completed
• Trial end date: 2012-04-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to investigate the effect of steady-state (constant concentration of medication in the blood) TMC278 on the single dose pharmacokinetics (what the body does to the medication) of digoxin.

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

Details

• Lead Sponsor: Janssen R&D Ireland
• Treatments: Digoxin; Rilpivirine

Criteria

Inclusion Criteria:

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

• Men must agree to use a highly effective method of birth control and to not donate sperm during the study and for 3 months after receiving the last dose of study medication

Exclusion Criteria:

• A positive HIV-1 or HIV-2 test at screening

• Hepatitis A, B or C infection at screening

• History of clinically relevant heart rhythm disturbances

• History of idiopathic hypertrophic subaortic stenosis, atrioventricular block, ventricular tachycardia/ventricular fibrillation or family history of sudden cardiac death