Status:
COMPLETED
TMC278-TiDP6-C121: Drug-drug Interaction Trial to Investigate the Potential Interaction Between TMC278 25 mg Daily and Methadone, at Steady State.
Lead Sponsor:
Tibotec Pharmaceuticals, Ireland
Conditions:
HIV
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
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 m...
Detailed Description
This is a Phase I, open-label, single-sequence drug-drug interaction trial in patients on stable methadone maintenance therapy, to investigate the potential interaction between TMC278 25 mg daily and ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2009
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT00744770
Start Date
October 1 2008
End Date
June 1 2009
Last Update
April 28 2010
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.