A Study to Explore Pharmacokinetic Interaction Between Rilpivirine and Metformin in Healthy Participants

• Status: Completed
• Trial end date: 2013-01-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the study is to evaluate the effect of steady-state (constant concentration of medication in the blood) rilpivirine on pharmacokinetics (how a single dose of metformin is absorbed in the body, distributed within the body, and removed from the body) of a single dose of metformin, over time, in healthy adult participants.

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

Details

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

Criteria

Inclusion Criteria:

• Participants should be healthy on the basis of physical examination, medical history, vital signs, electrocardiogram, the results of blood biochemistry and hematology tests and a urinalysis performed at screening

• Participant must have a Body Mass Index of 18.5 to 30.0 kg/m2

• Male participants should agree to protocol-defined use of effective contraception and women must be postmenopausal or surgically sterile

• Female participants must have a negative pregnancy test at screening

• Participants must be non-smoking for at least 3 months prior to screening

Exclusion Criteria:

• A positive Human immunodeficiency virus (HIV)-1 or HIV-2 test and Hepatitis A, B or C infection at screening

• Currently active clinically significant gastrointestinal, cardiovascular, neurologic, psychiatric, metabolic, endocrine, renal, hepatic, respiratory, inflammatory or infectious disease with any history of clinically significant skin disease

• Any history of tuberculosis, ocular herpes, or uveitis

• Have previously participated in more than one study with etravirine - TMC120 (dapivirine) and/or rilpivirine

• Participants with abnormal laboratory values at screening