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

• Status: Completed
• Trial end date: 2009-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

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

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.