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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-08-31

Study Completion Date

2012-11-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Hepatitis C

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Methadone group

patients on stable methadone therapy (at least 30 days) up to a maximum of 180mg per day

Group Type ACTIVE_COMPARATOR

BI 201335

Intervention Type DRUG

BI 201335 for 9 days

Buprenorphine

patients on stable buprenorphine/naloxone therapy (at least 30 days) up to a maximum dose of 24mg/6mg per day.

Group Type ACTIVE_COMPARATOR

BI 201335

Intervention Type DRUG

BI 201335 for 9 days

Interventions

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BI 201335

BI 201335 for 9 days

Intervention Type DRUG

BI 201335

BI 201335 for 9 days

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No