A Phase I, Open-label Trial to Explore the Pharmacokinetics, Safety and Tolerability of TMC278 (Rilpivirine) 25 mg Once Daily Following a 2-week Period Receiving Efavirenz, in Healthy Male and Female Volunteers

• Status: Completed
• Trial end date: 2010-05-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to investigate the pharmacokinetics of TMC278 (rilpivirine) 25 mg once daily following a preceding 2-week treatment period with efavirenz 600 mg once daily in healthy volunteers

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

Details

• Lead Sponsor: Tibotec, Inc
• Collaborator: Tibotec Therapeutics, a Division of Ortho Biotech Products, L.P., USA
• Treatments: Efavirenz; Rilpivirine

Criteria

Inclusion Criteria:

• Non-vasectomized heterosexually active male volunteers with female partner of childbearing potential must be using a highly effective method of birth control (i.e., male condom with either female intrauterine device, diaphragm, cervical cap or hormonal based contraceptives) and must agree to use these birth control methods during the trial and until 30 days after the end of the trial

• Able to comply with all protocol requirements

• Normal resting ECG at screening including

• Volunteers must have signed an Informed Consent Form (ICF) voluntarily before the first trial-related activity indicating that they understand the purpose of and procedures required for the trial and are willing to participate in the trial

• To participate in the optional pharmacogenomic component of this trial, volunteers must have signed the ICF for pharmacogenomic research indicating willingness to participate in the pharmacogenomic component of the trial. Refusal to give consent for this component does not exclude a volunteers from participation in the clinical trial

• Healthy on the basis of a medical evaluation that confirms the absence of any clinically relevant abnormality and includes a physical examination (including skin examination), medical history, vital signs, the results of blood biochemistry and hematology tests and a urinalysis carried out at screening.

Exclusion Criteria:

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

• Females of childbearing potential

• Hepatitis A infection (confirmed by hepatitis A antibody IgM), hepatitis B infection (confirmed by hepatitis B surface antigen), or hepatitis C infection (confirmed by hepatitis C virus antibody) diagnosed at trial screening

• Currently active clinically significant disease (e.g., pancreatitis, cardiac dysfunction) or findings during screening of medical history, laboratory or physical examination that in the investigator's opinion would compromise subject safety or the outcome of the trial

• Current or recent (within 3 months prior to the first administration of trial medication) gastrointestinal disease

• Any history of significant skin disease such as but not limited to rash or eruptions, drug allergies, food allergy, dermatitis, eczema, psoriasis, or urticaria

• A positive alcohol test or urine drug test at study screening