TMC278-TiDP6-C121: Drug-drug Interaction Trial to Investigate the Potential Interaction Between TMC278 25 mg Daily and Methadone, at Steady State.

NCT00744770 | Completed Phase 1

• 1 other identifier: CR002524
• Study Type: interventional
• Target: 13
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this Phase I, open-label, single-sequence drug-drug interaction trial in patients on stable methadone maintenance therapy is to investigate the potential interaction between TMC278 25 mg daily and methadone, at steady-state.

Conditions

HIV

Keywords

TMC278-TiDP6-C121; TMC278-C121; open-label; drug-drug interaction; methadone; TMC278

Outcome Measures

Primary Outcomes (1)

• To evaluate the effect of steady-state TMC278 25 mg q.d. on the steady-state pharmacokinetics of R- and S-methadone after 11 days of TMC278 intake.

Secondary Outcomes (1)

• To evaluate after 11 days of TMC278 intake: the potential effect of TMC278 on the pharmacodynamic effects of methadone therapy; the steady-state pharmacokinetics of TMC278 25 mg daily; the short-term safety and tolerability of coadministration.

Interventions

TMC278 DRUG

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Body Mass Index of 18.0 to 30.0 kg/m2, extremes included
• Receiving once daily oral methadone maintenance therapy at a stable individualized dose of 60 to 150 mg
• The patient agrees not to change the current methadone dose from screening until Day 11 included and to have a daily observed and documented methadone intake from Day -14 until Day 12, and a daily observed and documented TMC278 intake from Day 1 until Day 11
• Able to comply with protocol requirements
• The patient has obtained approval from his/her addiction physician for participation in this trial. Furthermore, the addiction physician agrees to provide medical care for the patient after discharge from the testing facility
• General medical condition, in the investigator's opinion, does not interfere with the assessments and the completion of the trial
• Otherwise healthy on the basis of a physical examination, medical history (except drug abuse), ECG, vital signs and the results of blood biochemistry and hematology tests and a urinalysis carried out at screening.

You may not qualify if:

• A positive test for HIV-1, HIV-2, hepatitis A virus or hepatitis B virus
• female of child bearing potential
• evidence of current use of illicit drugs or opioids (with the exception of methadone) or abuse of alcohol
• impaired liver function as defined in the protocol
• other currently active or underlying disorders, including gastrointestinal, cardiovascular, neurologic, psychiatric (other than drug dependency), metabolic, adrenal, renal, hepatic, respiratory, inflammatory, or infectious disease
• presence of risk factors for QTc prolongation
• any history of significant skin disease or allergies, including allergy or hypersensitivity to the excipients of the investigational medication TMC278 or to methadone
• Previous experience of clinically significant hypersensitivity to methadone hydrochloride
• Use of disallowed concomitant therapy during the 14 days prior to the first dose of TMC278
• recent donation of blood or plasma or participation in a clinical trial.

Sponsors & Collaborators

• Tibotec Pharmaceuticals, Ireland: lead

Related Publications (1)

• Crauwels HM, van Heeswijk RP, Vandevoorde A, Buelens A, Stevens M, Hoetelmans RM. The effect of rilpivirine on the pharmacokinetics of methadone in HIV-negative volunteers. J Clin Pharmacol. 2014 Feb;54(2):133-40. doi: 10.1002/jcph.222. Epub 2013 Nov 23.

  PMID: 24203510 DERIVED

MeSH Terms

Interventions

Rilpivirine

Intervention Hierarchy (Ancestors)

Nitriles; Organic Chemicals; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Tibotec Pharmaceuticals Limited Clinical Trial

  Tibotec Pharmaceutical Limited

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: August 29, 2008
• First Posted: September 1, 2008
• Study Start: October 1, 2008
• Primary Completion: June 1, 2009
• Study Completion: June 1, 2009
• Last Updated: April 28, 2010

Record last verified: 2010-04