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

Information source: Tibotec Pharmaceuticals, Ireland
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hepatitis C

Intervention: TMC435 (Drug); Methadone (Other)

Phase: Phase 1

Status: Completed

Sponsored by: Tibotec Pharmaceuticals, Ireland

Official(s) and/or principal investigator(s):
Tibotec Pharmaceuticals, Ireland Clinical Trial, Study Director, Affiliation: Tibotec Pharmaceuticals, Ireland

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.

Clinical Details

Official title: A Phase I, Open-Label, Single-Sequence Drug-Drug Interaction Trial in Subjects On Stable Methadone Maintenance Therapy, to Investigate the Potential Pharmacokinetic Interaction Between TMC435 and Methadone, at Steady-State

Study design: Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Predose plasma concentration of S-methadone

Maximum plasma concentration of S-methadone

Minimum plasma concentration between 0 hour and dosing interval of S-methadone

Average steady-state plasma concentration of S-methadone

Time to reach the maximum plasma concentration of S-methadone

Area under the curve from time of administration up to 24 hours post dosing of S-methadone

Fluctuation index of S-methadone, ie, percentage fluctuation (variation between maximum and minimum concentration at steady-state)

Predose plasma concentration of R-methadone

Maximum plasma concentration of R-methadone

Minimum plasma concentration between 0 hour and dosing interval of R- and S-methadone

Average steady-state plasma concentration of R-methadone

Time to reach the maximum plasma concentration of R-methadone

Area under the curve from time of administration up to 24 hours post dosing of R-methadone

Fluctuation index of R-methadone, ie, percentage fluctuation (variation between maximum and minimum concentration at steady-state)

Predose plasma concentration of TMC435

Maximum plasma concentration of TMC435

Minimum plasma concentration between 0 hour and dosing interval of TMC435

Average steady-state plasma concentration of TMC435

Time to reach the maximum plasma concentration of TMC435

Area under the curve from time of administration up to 24 hours post dosing of TMC435

Fluctuation index of TMC435, ie, percentage fluctuation (variation between maximum and minimum concentration at steady-state)

Secondary outcome:

Short Opiate Withdrawal Scale Scores

Desires for Drugs Questionnaire

Resting pupil diameter

Number of participants with adverse events as a measure of safety and tolerability

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 participants on stable maintenance therapy (for at least 30 days before screening) will be enrolled in the study. The study will consist of 3 phases: 1) Run-in phase: during this phase, participants will take individualized (dose of methadone will be adjusted for each participant between a range of 30 and 150 mg daily) dose of methadone from

Day - 14 (14 days before the first intake of TMC435) till Day -1 (1 day before the first

intake of TMC435), which will be supervised by the medical staff. 2) 7 days treatment phase: during this phase, the participants will take 150 mg dose of TMC435 once daily from Day 1 to Day 7 orally (by mouth) plus the individualized dose of methadone which will be supervised by the medical staff. 3) Follow-up phase: during this phase, the participants will continue to take only the individualized dose of methadone for 30-32 days. Safety evaluations will include assessment of adverse events, clinical laboratory tests, cardiovascular safety, physical examination and alcohol breath test. The total study duration will be of 22 days excluding screening and follow-up phase.

Eligibility

Minimum age: 18 Years. Maximum age: 55 Years. Gender(s): Both.

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

Locations and Contacts

Toronto, Canada
Additional Information

A Phase I, Open-Label, Single-Sequence Drug-Drug Interaction Trial in Subjects On Stable Methadone Maintenance Therapy, to Investigate the Potential Pharmacokinetic Interaction Between TMC435 and Methadone, at Steady-State

Starting date: September 2009
Last updated: October 11, 2013

Page last updated: August 23, 2015

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