A Study to Evaluate the Pharmacokinetic Effect of SCH 503034 (Boceprevir) on Methadone or Buprenorphine/Naloxone Plasma Concentrations (P08123)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01396005
First received: June 28, 2011
Last updated: February 28, 2014
Last verified: February 2014
Results First Received: December 6, 2012  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Pharmacokinetics Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Hepatitis C Virus
Interventions: Drug: boceprevir
Drug: methadone
Drug: buprenorphine/naloxone

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Methadone + Boceprevir Participants receive standard methadone maintenance therapy (20-150 mg tablets, liquid, or disket, orally, once per day) on Days 1 through 8 + boceprevir (800 mg [4 x 200 mg capsules], orally, every 8 hours) on Days 2 through 7)
Buprenorphine/Naloxone + Boceprevir Participants receive standard buprenorphine/naloxone maintenance therapy (8/2-24/6 mg, tablets, sublingual, once per day) on Days 1 through 8 + boceprevir (800 mg [4 x 200 mg capsules], orally, every 8 hours) on Days 2 through 7

Participant Flow:   Overall Study
    Methadone + Boceprevir     Buprenorphine/Naloxone + Boceprevir  
STARTED     10     11  
COMPLETED     10     9  
NOT COMPLETED     0     2  
Withdrawal by Subject                 0                 1  
Non-compliance with protocol                 0                 1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Methadone + Boceprevir Participants receive standard methadone maintenance therapy (20-150 mg tablets, liquid, or disket, orally, once per day) on Days 1 through 8 + boceprevir (800 mg [4 x 200 mg capsules], orally, every 8 hours) on Days 2 through 7)
Buprenorphine/Naloxone + Boceprevir Participants receive standard buprenorphine/naloxone maintenance therapy (8/2-24/6 mg, tablets, sublingual, once per day) on Days 1 through 8 + boceprevir (800 mg [4 x 200 mg capsules], orally, every 8 hours) on Days 2 through 7
Total Total of all reporting groups

Baseline Measures
    Methadone + Boceprevir     Buprenorphine/Naloxone + Boceprevir     Total  
Number of Participants  
[units: participants]
  10     11     21  
Age  
[units: years]
Mean ± Standard Deviation
  34.2  ± 10.2     33.2  ± 29.0     33.7  ± 10.1  
Gender  
[units: participants]
     
Female     2     2     4  
Male     8     9     17  



  Outcome Measures
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1.  Primary:   Area Under the Concentration Versus Time Curve (AUC) at Steady State of Methadone Enantiomers When Administered With or Without Boceprevir   [ Time Frame: Methadone samples collected Day 1, 0 (predose) through 24 hours post-dose (Day 2). Boceprevir and methadone samples collected Day 7, 0 (predose) through 24 hours post-dose (Day 8). Predose samples also collected on Days 5-6. ]

2.  Primary:   Maximum Concentration (Cmax) at Steady State of Methadone Enantiomers When Administered With or Without Boceprevir   [ Time Frame: Methadone samples collected Day 1, 0 (predose) through 24 hours post-dose (Day 2). Boceprevir and methadone samples collected Day 7, 0 (predose) through 24 hours post-dose (Day 8). Predose samples also collected on Days 5-6. ]

3.  Primary:   AUC of Buprenorphine (Administered in Combination With Naloxone) at Steady State With or Without Boceprevir   [ Time Frame: Buprenorphine/naloxone samples collected Day 1, 0 (predose) through 24 hours post-dose (Day 2). Boceprevir and buprenorphine/naloxone samples collected Day 7, 0 (predose) through 24 hours post-dose (Day 8). Predose samples also collected on Days 5-6. ]

4.  Primary:   Cmax of Buprenorphine (Administered in Combination With Naloxone) at Steady State With or Without Boceprevir   [ Time Frame: Buprenorphine/naloxone samples collected Day 1, 0 (predose) through 24 hours post-dose (Day 2). Boceprevir and buprenorphine/naloxone samples collected Day 7, 0 (predose) through 24 hours post-dose (Day 8). Predose samples also collected on Days 5-6. ]

5.  Secondary:   AUC of Naloxone (Administered in Combination With Buprenorphine) at Steady State With or Without Boceprevir   [ Time Frame: Buprenorphine/naloxone samples collected Day 1, 0 (predose) through 24 hours post-dose (Day 2). Boceprevir and buprenorphine/naloxone samples collected Day 7, 0 (predose) through 24 hours post-dose (Day 8). Predose samples also collected on Days 5-6. ]

6.  Secondary:   Cmax of Naloxone (Administered in Combination With Buprenorphine) at Steady State With or Without Boceprevir   [ Time Frame: Buprenorphine/naloxone samples collected Day 1, 0 (predose) through 24 hours post-dose (Day 2). Boceprevir and buprenorphine/naloxone samples collected Day 7, 0 (predose) through 24 hours post-dose (Day 8). Predose samples also collected on Days 5-6. ]


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  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Vice President, Late Stage Development Group Leader
Organization: Merck Sharp & Dohme Corp
phone: 1-800-672-6327
e-mail: ClinicalTrialsDisclosure@merck.com


No publications provided


Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01396005     History of Changes
Other Study ID Numbers: P08123
Study First Received: June 28, 2011
Results First Received: December 6, 2012
Last Updated: February 28, 2014
Health Authority: United States: Food and Drug Administration