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Completed

NCT Number: NCT01637922

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

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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Key information

Conditions

Hepatitis C Blood-Borne Infections Communicable Diseases Digestive System Diseases Flaviviridae Infections Hepatitis Hepatitis, Viral, Human Infections Liver Diseases RNA Virus Infections Virus Diseases

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

1220.57.0001 Boehringer Ingelheim Investigational Site, Atlanta, Georgia, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

BI 201335

Drug

BI 201335 for 9 days

Primary outcomes

  1. R-methadone: Geometric Mean Steady-state AUC0-24 on Day 1 and on Day 9.

    Time frame: 0 hours, 0.5 hours, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours and 24 hours on Day 1 and Day 9

    These are the unadjusted summary statistics on the original scale for area under the concentration time curve (AUC) of faldaprevir in plasma over a uniform dosing interval from 0 to 24 hours.

  2. R-methadone: Geometric Mean Steady-state Cmax on Day 1 and on Day 9.

    Time frame: 0 hours, 0.5 hours, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours and 24 hours on Day 1 and Day 9

    These are the unadjusted summary statistics on the original scale for the maximum measured concentration of faldaprevir in plasma at steady state.

  3. R-methadone: Geometric Mean Steady-state C24hr on Day 1 and on Day 9.

    Time frame: 0 hours, 0.5 hours, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours and 24 hours on Day 1 and Day 9

    These are the unadjusted summary statistics on the original scale for steady-state plasma concentration of faldaprevir 24 hours after the last dose

  4. S-methadone: Geometric Mean Steady-state AUC0-24 on Day 1 and on Day 9

    Time frame: 0 hours, 0.5 hours, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours and 24 hours on Day 1 and Day 9

    These are the unadjusted summary statistics on the original scale for area under the concentration time curve (AUC) of faldaprevir in plasma over a uniform dosing interval from 0 to 24 hours.

  5. S-methadone: Geometric Mean Steady-state Cmax on Day 1 and on Day 9

    Time frame: 0 hours, 0.5 hours, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours and 24 hours on Day 1 and Day 9

    These are the unadjusted summary statistics on the original scale for the maximum measured concentration of faldaprevir in plasma at steady state.

  6. S-methadone: Geometric Mean Steady-state C24hr on Day 1 and on Day 9

    Time frame: 0 hours, 0.5 hours, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours and 24 hours on Day 1 and Day 9

    These are the unadjusted summary statistics on the original scale for steady-state plasma concentration of faldaprevir 24 hours after the last dose

  7. Buprenorphine: Geometric Mean Steady-state AUC0-24 on Day 1 and on Day 9.

    Time frame: 0 hours, 0.5 hours, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours and 24 hours on Day 1 and Day 9

    These are the unadjusted summary statistics on the original scale for area under the concentration time curve (AUC) of faldaprevir in plasma over a uniform dosing interval from 0 to 24 hours.

  8. Buprenorphine: Geometric Mean Steady-state Cmax on Day 1 and on Day 9.

    Time frame: 0 hours, 0.5 hours, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours and 24 hours on Day 1 and Day 9

    These are the unadjusted summary statistics on the original scale for the maximum measured concentration of faldaprevir in plasma at steady state.

  9. Buprenorphine: Geometric Mean Steady-state C24hr on Day 1 and on Day 9.

    Time frame: 0 hours, 0.5 hours, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours and 24 hours on Day 1 and Day 9

    These are the unadjusted summary statistics on the original scale for steady-state plasma concentration of faldaprevir 24 hours after the last dose

  10. Norbuprenorphine: Geometric Mean Steady-state AUC0-24 on Day 1 and on Day 9.

    Time frame: 0 hours, 0.5 hours, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours and 24 hours on Day 1 and Day 9

    These are the unadjusted summary statistics on the original scale for area under the concentration time curve (AUC) of faldaprevir in plasma over a uniform dosing interval from 0 to 24 hours.

  11. Norbuprenorphine: Geometric Mean Steady-state Cmax on Day 1 and on Day 9.

    Time frame: 0 hours, 0.5 hours, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours and 24 hours on Day 1 and Day 9

    These are the unadjusted summary statistics on the original scale for the maximum measured concentration of faldaprevir in plasma at steady state.

  12. Norbuprenorphine: Geometric Mean Steady-state C24hr on Day 1 and on Day 9.

    Time frame: 0 hours, 0.5 hours, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours and 24 hours on Day 1 and Day 9

    These are the unadjusted summary statistics on the original scale for steady-state plasma concentration of faldaprevir 24 hours after the last dose

  13. Naloxone: Geometric Mean Steady-state AUC0-24 on Day 1 and on Day 9.

    Time frame: 0 hours, 0.5 hours, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours and 24 hours on Day 1 and Day 9

    These are the unadjusted summary statistics on the original scale for area under the concentration time curve (AUC) of faldaprevir in plasma over a uniform dosing interval from 0 to 24 hours.

  14. Naloxone: Geometric Mean Steady-state Cmax on Day 1 and on Day 9.

    Time frame: 0 hours, 0.5 hours, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours and 24 hours on Day 1 and Day 9

    These are the unadjusted summary statistics on the original scale for the maximum measured concentration of faldaprevir in plasma at steady state.

  15. Naloxone: Geometric Mean Steady-state C24hr on Day 1 and on Day 9.

    Time frame: 0 hours, 0.5 hours, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours and 24 hours on Day 1 and Day 9

    These are the unadjusted summary statistics on the original scale for steady-state plasma concentration of faldaprevir 24 hours after the last dose

Secondary outcomes

  1. Pharmacodynamic Assessment of Withdrawal From Either Methadone or Buprenorphine/Naloxone Using the Objective Opiate Withdrawal Scale (OOWS)-Change From Baseline

    Time frame: Baseline, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9, Day 10, Day 11, Day 12 and End of treatment

    The OOWS is conducted by a trained independent examiner for either the presence or absence of the following symptoms during a 10 minute observation period at designated times during the trial. The minimum possible OOWS score is 0 and the maximum possible score is 13. Objective criteria: Yawning, Rhinorrhoea, Piloerection, perspiration, lacrimation, mydriasis, hot and cold flushes, restlessness, vomiting, tremors, anxiety, muscle twitches, abdominal cramps. Higher score indicates increasing severity of opiate withdrawal syndrome.

  2. Pharmacodynamic Assessment of Withdrawal From Either Methadone or Buprenorphine/Naloxone Using the Subjective Opiate Withdrawal Scale (SOWS)-Change From Baseline

    Time frame: Baseline, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9, Day 10, Day 11, Day 12 and End of treatment

    The SOWS is a subjective scale self-evaluated by the subject. The SOWS shows items reflecting the common motor, autonomic, gastrointestinal, musculo-skeletal, and psychic symptoms of opiate withdrawal. Subjects are instructed to rate each symptom on a scale of 0 to 4 (0=not at all, 1=a little, 2=moderately, 3=quite a bit, 4=extremely) at designated times [c.f. Section 3.1]. The minimum possible SOWS score is 0, the maximum 64. The following subjective criteria are answered by the subject using the scale below: 1) I feel anxious, 2) I feel like yawning 3) I am perspiring, 4) My eyes are watering, 5) My nose is running, 6) I have goose flesh, 7) I am shaking 8) I have hot flushes, 9) I have cold flushes, 10) My bones and muscles ache, 11) I feel restless, 12) I feel nauseous, 13) I feel like vomiting, 14) My muscles twitch, 15) I have cramps in my stomach, 16) I feel like shooting up now. Higher score indicates increasing severity of opiate withdrawal syndrome.

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Jul 11, 2012
Registry last updated
Aug 3, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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