Status:
COMPLETED
A Study to Investigate the Potential Pharmacokinetic Interaction Between TMC435 and Methadone
Lead Sponsor:
Tibotec Pharmaceuticals, Ireland
Conditions:
Hepatitis C
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief 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 ...
Detailed Description
This is an open label (all people know the identity of the intervention) drug-drug interaction (TMC435 versus methadone) study. Approximately 12 hepatitis C virus-negative opioid-dependent participant...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2010
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT00915564
Start Date
September 1 2009
End Date
January 1 2010
Last Update
October 16 2013
Active Locations (1)
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1
Toronto, Canada