A Study to Investigate the Potential Pharmacokinetic Interaction Between TMC435 and Methadone

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

Summary

The purpose of this study is to evaluate the effect of steady-state (constant concentration of medication in the blood) TMC435 (150 mg, once a day) on the steady state pharmacokinetics (what the body does to the medication) of R- and S-methadone.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Tibotec Pharmaceuticals, Ireland
• Treatments: Methadone; Simeprevir

Criteria

Inclusion Criteria:

• Receiving once daily oral methadone maintenance therapy at a stable individualized dose of 30 to 130 mg once daily for at least 30 days prior to screening

• Agreeing not to change the current methadone dose from screening until Day7 included and to have a daily observed and documented methadone intake from Day-14 until Day8 and to have a daily observed and documented TMC435 intake from Day1 until Day 7

• Having obtained approval from his/her addiction physician for participation in the trial and addiction physician agrees to provide medical care for the volunteer after discharge from the testing facility

Exclusion Criteria:

• No female of childbearing potential, except if using effective birth control methods during the trial and for at least 30 days after the end of the treatment period

• No positive testing for drugs of abuse

• No positive testing for Hepatitis A, B and C and for HIV1 and 2

• Impaired liver disease or other clinically relevant diseases