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

Completed · Phase 1

Conditions studied: Hepatitis C

In brief

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.

Key facts

Study ID

NCT01637922

Run by

Boehringer Ingelheim

People needed

34

Starts

2012-08-01

Expected to finish

2012-11-01

Last updated by the study team

2015-08-03

Who can join

Age: 18 and older, up to 64. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• stable dose of either methadone or buprenorphine/naloxone for 30 days for opioid maintenance therapy.
• Male and female volunteers with a body mass index (BMI) = 18.5 and < 32 with a minimum weight of 50kg.

You may not qualify if…

• any other significant medical illness of clinical significance.
• history of rash or photosensitivity
• chronic or acute infections including HIV, hepatitis B and hepatitis C.
• history of allergy considered significant for this study
• intake of any other medications except for methadone or buprenorphine/naloxone.
• QTc on electrocardiogram (ECG) > 470.
• use of any other investigational drug within 30 days of the study.
• drug or alcohol abuse (other than the defined opioid maintenance therapy with either methadone or buprenorphine/naloxone)
• blood donation of more than 100mL within four weeks of the trial.
• excessive physical activities one week prior to and during the trial.
• any clinically relevant laboratory value.
• 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.
• inadequate venous access
• For women of childbearing potential:
• pregnancy or planning to become pregnant within 3 months of the trial
• positive pregnancy test at screening visit
• 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.
• lactation with active breastfeeding from screening up to 30 days after last study visit.

Where it is running

• 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

Full record on ClinicalTrials.gov

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