Drug Interaction Study With BI 201335 and Methadone or Buprenorphine/Naloxone
Information source: Boehringer Ingelheim
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hepatitis C
Intervention: BI 201335 (Drug); BI 201335 (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Boehringer Ingelheim Official(s) and/or principal investigator(s):
Boehringer Ingelheim, Study Chair, Affiliation: Boehringer Ingelheim
Summary
Otherwise healthy subjects who are currently bein maintained on either methadone or
buprenorphine/naloxone for opioid maintenance therapy who have been on a stable dose for at
least 30 days will be administered BI 201335 daily to determine if a drug interaction occurs
between BI 201335 and either methadone or buprenorphine/naloxone.
Clinical Details
Official title: Effect of Multiple Dosing With BI 201335 on the Safety, Pharmacokinetics and Pharmacodynamics of Steady-state Methadone and Buprenorphine/Naloxone in Subjects on Stable Addiction Management Therapy
Study design: Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: R-methadone: Geometric Mean Steady-state AUC0-24 on Day 1 and on Day 9.R-methadone: Geometric Mean Steady-state Cmax on Day 1 and on Day 9. R-methadone: Geometric Mean Steady-state C24hr on Day 1 and on Day 9. S-methadone: Geometric Mean Steady-state AUC0-24 on Day 1 and on Day 9 S-methadone: Geometric Mean Steady-state Cmax on Day 1 and on Day 9 S-methadone: Geometric Mean Steady-state C24hr on Day 1 and on Day 9 Buprenorphine: Geometric Mean Steady-state AUC0-24 on Day 1 and on Day 9. Buprenorphine: Geometric Mean Steady-state Cmax on Day 1 and on Day 9. Buprenorphine: Geometric Mean Steady-state C24hr on Day 1 and on Day 9. Norbuprenorphine: Geometric Mean Steady-state AUC0-24 on Day 1 and on Day 9. Norbuprenorphine: Geometric Mean Steady-state Cmax on Day 1 and on Day 9. Norbuprenorphine: Geometric Mean Steady-state C24hr on Day 1 and on Day 9. Naloxone: Geometric Mean Steady-state AUC0-24 on Day 1 and on Day 9. Naloxone: Geometric Mean Steady-state Cmax on Day 1 and on Day 9. Naloxone: Geometric Mean Steady-state C24hr on Day 1 and on Day 9.
Secondary outcome: Pharmacodynamic Assessment of Withdrawal From Either Methadone or Buprenorphine/Naloxone Using the Objective Opiate Withdrawal Scale (OOWS)-Change From BaselinePharmacodynamic Assessment of Withdrawal From Either Methadone or Buprenorphine/Naloxone Using the Subjective Opiate Withdrawal Scale (SOWS)-Change From Baseline
Eligibility
Minimum age: 18 Years.
Maximum age: 64 Years.
Gender(s): Both.
Criteria:
Inclusion criteria:
1. stable dose of either methadone or buprenorphine/naloxone for 30 days for opioid
maintenance therapy.
2. Male and female volunteers with a body mass index (BMI) = 18. 5 and < 32 with a
minimum weight of 50kg.
Exclusion criteria:
1. any other significant medical illness of clinical significance.
2. history of rash or photosensitivity
3. chronic or acute infections including HIV, hepatitis B and hepatitis C.
4. history of allergy considered significant for this study
5. intake of any other medications except for methadone or buprenorphine/naloxone.
6. QTc on electrocardiogram (ECG) > 470.
7. use of any other investigational drug within 30 days of the study.
8. drug or alcohol abuse (other than the defined opioid maintenance therapy with either
methadone or buprenorphine/naloxone)
9. blood donation of more than 100mL within four weeks of the trial.
10. excessive physical activities one week prior to and during the trial.
11. any clinically relevant laboratory value.
12. concomitant use of any food product known to alter P450 or P-gp activity such as
grapefruit juice, seville oranges and St. John's Wort.
13. inadequate venous access
For women of childbearing potential:
14. pregnancy or planning to become pregnant within 3 months of the trial
15. positive pregnancy test at screening visit
16. no proof of sterilization or unwilling or unable to use a double barrier method of
birth control during the study and up to 3 months after the study.
17. lactation with active breastfeeding from screening up to 30 days after last study
visit.
Locations and Contacts
1220.57.0001 Boehringer Ingelheim Investigational Site, Atlanta, Georgia, United States
1220.57.0002 Boehringer Ingelheim Investigational Site, Overland Park, Kansas, United States
1220.57.0003 Boehringer Ingelheim Investigational Site, Salt Lake City, Utah, United States
Additional Information
Starting date: August 2012
Last updated: July 3, 2015
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