Drug Interaction Study With BI 201335 and Methadone or Buprenorphine/Naloxone

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01637922
First received: July 9, 2012
Last updated: May 15, 2013
Last verified: May 2013
  Purpose

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.


Condition Intervention Phase
Hepatitis C
Drug: BI 201335
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • R-methadone and S-methadone: geometric mean steady-state C24hr on Day 1 and on Day 9. [ Time Frame: up to 9 days ] [ Designated as safety issue: No ]
  • Buprenorphine, norbuprenorphine and naloxone: geometric mean steady-state Cmax on Day 1 and on Day 9. [ Time Frame: up to 9 days ] [ Designated as safety issue: No ]
  • Buprenorphine, norbuprenorphine and naloxone: geometric mean steady-state C24hr on Day 1 and on Day 9. [ Time Frame: up to 9 days ] [ Designated as safety issue: No ]
  • R-methadone and S-methadone: geometric mean steady-state Cmax on Day 1 and on Day 9. [ Time Frame: up to 9 days ] [ Designated as safety issue: No ]
  • R-methadone and S-methadone: geometric mean steady-state AUC0-24 on Day 1 and on Day 9. [ Time Frame: up to 9 days ] [ Designated as safety issue: No ]
  • Buprenorphine, norbuprenorphine and naloxone: geometric mean steady-state AUC0-24 on Day 1 and on Day 9. [ Time Frame: up to 9 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pharmacodynamic assessment of withdrawal from either methadone or buprenorphine/naloxone using the Objective Opiate Withdrawal scale (OOWS) and the Subjective Opiate Withdrawal Scale (SOWS) [ Time Frame: up to 13 days ] [ Designated as safety issue: No ]

Enrollment: 34
Study Start Date: August 2012
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Methadone group
patients on stable methadone therapy (at least 30 days) up to a maximum of 180mg per day
Drug: BI 201335
BI 201335 for 9 days
Active Comparator: Buprenorphine
patients on stable buprenorphine/naloxone therapy (at least 30 days) up to a maximum dose of 24mg/6mg per day.
Drug: BI 201335
BI 201335 for 9 days

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01637922

Locations
United States, Georgia
1220.57.0001 Boehringer Ingelheim Investigational Site
Atlanta, Georgia, United States
United States, Kansas
1220.57.0002 Boehringer Ingelheim Investigational Site
Overland Park, Kansas, United States
United States, Utah
1220.57.0003 Boehringer Ingelheim Investigational Site
Salt Lake City, Utah, United States
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

No publications provided

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01637922     History of Changes
Other Study ID Numbers: 1220.57
Study First Received: July 9, 2012
Last Updated: May 15, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Buprenorphine
Methadone
Naloxone
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Narcotic Antagonists
Antitussive Agents
Respiratory System Agents

ClinicalTrials.gov processed this record on August 28, 2014