NL-OMON32622
Completed
Not Applicable
A Phase I, open-label, single-sequence drug-drug interaction trial in subjects on stable methadone maintenance therapy, to investigate the potential interaction between TMC278 25 mg q.d. and methadone, at steady-state. - Trial to investigate the interaction between TMC278 and methadone.
TIBOTEC PHARMACEUTICALS LIMITED, EASTGATE VILLAGE, EASTGATE, LITTLE ISLAND, CO. CORK, IRELAND, In Nederland vertegenwoordigd door Janssen-Cilag B.V. afdeling GCO0 sites16 target enrollmentTBD
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- AIDS
- Sponsor
- TIBOTEC PHARMACEUTICALS LIMITED, EASTGATE VILLAGE, EASTGATE, LITTLE ISLAND, CO. CORK, IRELAND, In Nederland vertegenwoordigd door Janssen-Cilag B.V. afdeling GCO
- Enrollment
- 16
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Male or female, aged between 18 and 55 years, extremes included;
- •2\. Body Mass Index of 18\.0 to 35\.0 kg/m2, extremes included;
- •3\. Informed Consent Form signed voluntarily before first trial\-related activity;
- •4\. Receiving once daily oral methadone maintenance therapy at a stable individualized dose;
- •5\. The subject agrees:
- •\- not to change the current methadone dose from screening until Day 11 included;
- •\- 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;
- •6\. Able to comply with protocol requirements;
- •7\. The subject has obtained approval from his/her addiction physician for the subject\*s participation in this trial. Furthermore, the addiction physician agrees to provide medical care for the subject after discharge from trial center;
- •8\. General medical condition, in the investigator\*s opinion, does not interfere with the assessments and the completion of the trial;
Exclusion Criteria
- •1\. A positive HIV 1 or HIV 2 test at trial screening.
- •2\. Female, except if postmenopausal since more than 2 years, or posthysterectomy, or post surgical sterilization (without reversal operation).
- •3\. Evidence of current use of barbiturate, amphetamine, recreational drugs or opioids, with the exception of methadone.
- •4\. Current use of alcohol, which in the investigator\*s opinion would compromise subject\*s safety and/or compliance with the trial procedures.
- •5\. Hepatitis A infection at screening.
- •6\. Decompensated liver function
- •7\. Currently active or underlying gastrointestinal, cardiovascular, neurologic, psychiatric (other than drug dependency), metabolic, renal, hepatic, respiratory, inflammatory, or infectious disease.
- •8\. Significant heart abnormalities.
- •9\. Current or history of adrenal disorder.
- •10\. Currently significant diarrhea, gastric stasis, or constipation (other than the pharmacodynamic effects of methadone) that in the investigator\*s opinion could influence drug absorption or bioavailability.
Outcomes
Primary Outcomes
Not specified
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