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

NCT00915564 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2013-10-16

No results posted yet for this study

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.

Conditions

  • Hepatitis C

Interventions

DRUG

TMC435

Participants will receive 150 mg dose of TMC435 orally (by mouth) once daily for 7 days of treatment (from Day 1 to Day 7).

OTHER

Methadone

Participants will receive supervised individualized methadone dose (dose of methadone will be adjusted for each participant between a range of 30 and 150 mg daily \[extremes included\]) from Day -14 untill Day 8. Participants will continue to receive individualized methadone during follow up of 30 to 32 days.

Sponsors & Collaborators

  • Tibotec Pharmaceuticals, Ireland

    lead INDUSTRY

Principal Investigators

  • Tibotec Pharmaceuticals, Ireland Clinical Trial · Tibotec Pharmaceuticals, Ireland

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-09-30
Primary Completion
2010-01-31
Completion
2010-01-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00915564 on ClinicalTrials.gov