TMC435-TiDP16-C112 - Interaction Trial With Antidepressants

• Status: Completed
• Trial end date: 2010-09-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to investigate the effect of steady-state concentrations of TMC435 150mg q.d. (once a day) on the steady-state pharmacokinetics of escitalopram 10 mg q.d., and vice versa. Steady state is a term which means that the drug has been given long enough so that the plasma concentrations will remain the same with each subsequent dose. TMC435 is being investigated for the treatment of chronic hepatitis C virus (HCV) 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
• Treatments: Citalopram; Dexetimide; Simeprevir

Criteria

Inclusion Criteria:

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

• Healthy on the basis of physical examination, medical history, vital signs and 12-lead ECG performed at screening

• Healthy on the basis of clinical laboratory tests performed at screening

• Subjects must have signed an informed consent document indicating they understand the purpose of and procedures required for the study and are willing to participate in the study

• Participants must have signed the ICF for pharmacogenetic research indicating willingness to participate in the pharmacogenetic component of the study.

Exclusion Criteria:

• A positive human immunodeficiency virus - type 1 (HIV-1) or HIV-2 test at study screening

• Hepatitis A, B, or C infection (confirmed by hepatitis A antibody immunoglobulin [IgM], hepatitis B surface antigen, or hepatitis C virus antibody, respectively) at screening

• History of liver or renal (estimated creatinine clearance below 60 mL/min) insufficiency, significant cardiac, vascular, pulmonary, gastrointestinal (such as significant diarrhea, gastric stasis, or constipation that in the investigator's opinion could influence drug absorption or bioavailability), endocrine, neurologic, hematologic, rheumatologic, psychiatric and neoplastic or metabolic disturbances

• Known allergies, hypersensitivity, or intolerance to TMC435 or its excipients

• Received an investigational drug (including investigational vaccines) or used an investigational medical device within 60 days before the planned start of treatment