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Comparison of Safety and Resulting Blood Level Profiles After Administration of a New Boceprevir Tablet Versus Its Current Capsule Formulation for Treatment of Chronic Hepatitis C (P06992)(COMPLETED)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01181804
First received: August 12, 2010
Last updated: October 21, 2014
Last verified: October 2014
Results First Received: March 23, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Bio-equivalence Study;   Intervention Model: Crossover Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Hepatitis C
Intervention: Drug: boceprevir

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Boceprevir Tablets Then Capsules ( Fed) Participants will start therapy with a single dose of boceprevir tablets, orally, in fed condition, and then 4 days later will take a single dose of boceprevir capsules, orally, in fed condition.
Boceprevir Capsules Then Tablets ( Fed) Participants will start therapy with a single dose of boceprevir capsules, orally, in fed condition, and then 4 days later will take a single dose of boceprevir tablets, orally, in fed condition.
Boceprevir Tablets Then Capsules (Fasted) Participants will start therapy with a single dose of boceprevir tablets, orally, following an overnight fast and then 4 days later will receive a single dose of boceprevir capsules, orally, following and overnight fast.
Boceprevir Capsules Then Tablets (Fasted) Participants will start therapy with a single dose of boceprevir capsules, orally, following an overnight fast and then 4 days later will receive a single dose of boceprevir tablets, orally, following and overnight fast.

Participant Flow for 4 periods

Period 1:   Period 1, Fed (Part 1)
    Boceprevir Tablets Then Capsules ( Fed)     Boceprevir Capsules Then Tablets ( Fed)     Boceprevir Tablets Then Capsules (Fasted)     Boceprevir Capsules Then Tablets (Fasted)  
STARTED     30     30     0     0  
COMPLETED     30     30     0     0  
NOT COMPLETED     0     0     0     0  

Period 2:   Period 2, Fed (Part 1)
    Boceprevir Tablets Then Capsules ( Fed)     Boceprevir Capsules Then Tablets ( Fed)     Boceprevir Tablets Then Capsules (Fasted)     Boceprevir Capsules Then Tablets (Fasted)  
STARTED     30     30     0     0  
COMPLETED     30     30     0     0  
NOT COMPLETED     0     0     0     0  

Period 3:   Period 3, Fasted (Part 2)
    Boceprevir Tablets Then Capsules ( Fed)     Boceprevir Capsules Then Tablets ( Fed)     Boceprevir Tablets Then Capsules (Fasted)     Boceprevir Capsules Then Tablets (Fasted)  
STARTED     0     0     59     58  
COMPLETED     0     0     59     58  
NOT COMPLETED     0     0     0     0  

Period 4:   Period 4, Fasted (Part 2)
    Boceprevir Tablets Then Capsules ( Fed)     Boceprevir Capsules Then Tablets ( Fed)     Boceprevir Tablets Then Capsules (Fasted)     Boceprevir Capsules Then Tablets (Fasted)  
STARTED     0     0     59     58  
COMPLETED     0     0     58     58  
NOT COMPLETED     0     0     1     0  



  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.
No text entered.

Reporting Groups
  Description
Boceprevir Tablets Then Capsules (Fed) Participants will start therapy with a single dose of boceprevir tablets, orally, in fed condition, and then 4 days later will take a single dose of boceprevir capsules, orally, in fed condition.
Boceprevir Capsules Then Tablets (Fed) Participants will start therapy with a single dose of boceprevir capsules, orally, in fed condition, and then 4 days later will take a single dose of boceprevir tablets, orally, in fed condition.
Boceprevir Tablets Then Capsules (Fasted) Participants will start therapy with a single dose of boceprevir tablets, orally, following an overnight fast and then 4 days later will receive a single dose of boceprevir capsules, orally, following and overnight fast.
Boceprevir Capsules Then Tablets (Fasted) Participants will start therapy with a single dose of boceprevir capsules, orally, following an overnight fast and then 4 days later will receive a single dose of boceprevir tablets, orally, following and overnight fast.
Total Total of all reporting groups

Baseline Measures
    Boceprevir Tablets Then Capsules (Fed)     Boceprevir Capsules Then Tablets (Fed)     Boceprevir Tablets Then Capsules (Fasted)     Boceprevir Capsules Then Tablets (Fasted)     Total  
Number of Participants  
[units: participants]
  30     30     59     58     177  
Age  
[units: Years]
         
<=18 years     0     0     0     0     0  
Between 18 and 65 years     30     30     59     58     177  
>=65 years     0     0     0     0     0  
Gender  
[units: participants]
         
Female     10     18     27     39     94  
Male     20     12     32     19     83  



  Outcome Measures
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1.  Primary:   Area Under the Concentration Curve (AUC) From Hour 0 to the Final Quantifiable Sample (AUCtf) for Boceprevir Tablets Versus Capsules in Fed State   [ Time Frame: Predose through 72 hours post-dose ]

2.  Primary:   Maximum Plasma Concentration (Cmax) of Boceprevir Tablets Versus Capsules in Fed State   [ Time Frame: Predose through 72 hours post-dose ]

3.  Primary:   AUCtf for Boceprevir Tablets Versus Capsules in Fasted State   [ Time Frame: Predose through 72 hours post-dose ]

4.  Primary:   Cmax of Boceprevir Tablets Versus Capsules in Fasted State   [ Time Frame: Predose through 72 hours post-dose ]

5.  Primary:   AUC From Hour 0 to Infinity (AUCinf) in Fed State   [ Time Frame: Predose through 72 hours post-dose ]

6.  Primary:   AUCinf in Fasted State   [ Time Frame: Predose through 72 hours post-dose ]

7.  Primary:   Half Life (t1/2) of Boceprevir in Fed State   [ Time Frame: Predose through 72 hours post-dose ]

8.  Primary:   t1/2 Boceprevir in Fasted State   [ Time Frame: Predose through 72 hours post-dose ]


  Serious Adverse Events


  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
e-mail: ClinicalTrialsDisclosure@merck.com


No publications provided


Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01181804     History of Changes
Other Study ID Numbers: P06992
Study First Received: August 12, 2010
Results First Received: March 23, 2012
Last Updated: October 21, 2014
Health Authority: United States: Food and Drug Administration