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)
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ClinicalTrials.gov Identifier: NCT01181804 |
Recruitment Status
:
Completed
First Posted
: August 13, 2010
Results First Posted
: April 18, 2012
Last Update Posted
: April 7, 2017
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Tracking Information | |||||
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First Submitted Date ICMJE | August 12, 2010 | ||||
First Posted Date ICMJE | August 13, 2010 | ||||
Results First Submitted Date | March 23, 2012 | ||||
Results First Posted Date | April 18, 2012 | ||||
Last Update Posted Date | April 7, 2017 | ||||
Study Start Date ICMJE | June 2010 | ||||
Actual Primary Completion Date | December 2010 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE |
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Change History | Complete list of historical versions of study NCT01181804 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures ICMJE | Not Provided | ||||
Original Secondary Outcome Measures ICMJE | Not Provided | ||||
Current Other Outcome Measures ICMJE | Not Provided | ||||
Original Other Outcome Measures ICMJE | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | 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) | ||||
Official Title ICMJE | A Definitive Bioequivalence Study of a New Boceprevir (SCH 503034) Tablet Formulation Compared to the Current Capsule Form in Healthy Male and Female Subjects. | ||||
Brief Summary | This is a single-dose, randomized, cross-sectional comparison study examining the relative safety and resulting blood level profiles after administration of a new boceprevir tablet formulation versus its current capsule formulation for treatment of chronic hepatitis C. In Part 1 of the study participants will receive boceprevir tablets and capsules under fed conditions. In Part 2 of the study a new group of participants will receive boceprevir tablets and capsules under fasted conditions. | ||||
Detailed Description | Not Provided | ||||
Study Type ICMJE | Interventional | ||||
Study Phase | Phase 1 | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Crossover Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Hepatitis C | ||||
Intervention ICMJE | Drug: boceprevir
Boceprevir (tablet or capsule) at 800 mg administered under either fed or fasted conditions.
Other Name: SCH 503034 |
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Study Arms |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Actual Enrollment ICMJE |
177 | ||||
Original Actual Enrollment ICMJE |
60 | ||||
Actual Study Completion Date | December 2010 | ||||
Actual Primary Completion Date | December 2010 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
testing, and able to adhere to applicable visit schedules. - Subjects of either gender and of any race between the ages of 18 and 65 years, inclusive, having a Body Mass Index (BMI) between 18 and 32, inclusive. BMI = weight (kg)/height (m)^2. (Individuals with values outside (or indicate lower or higher) of these ranges may be enrolled if clinically acceptable to the investigator and sponsor.)
within the following ranges: (Individuals with values outside of these ranges may be enrolled if clinically acceptable to the investigator and sponsor.)
i. stable oral, transdermal, injectable, or sustained-release vaginal hormonal contraceptive regimen without breakthrough uterine bleeding for 3 months prior to Screening; in addition, during study use of condom and/or spermicide (when marketed in the country). ii. intrauterine device (inserted at least 2 months prior to Screening visit); in addition, during study use of condom and/or spermicide (when marketed in the country). iii. condom (male or female) with spermicide (when marketed within the country), iv. diaphragm or cervical cap with spermicide (when marketed within the country) and condom (male), - Non-vasectomized men must agree to use a condom with spermicide or abstain from sexual intercourse, during the trial and for 1 month after stopping the medication. Exclusion Criteria:
absorption, distribution, metabolism or excretion of any drug. The investigator should be guided by evidence of any of the following, and be discussed with the sponsor prior to enrollment into the trial:
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Sex/Gender |
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Ages | 18 Years to 65 Years (Adult) | ||||
Accepts Healthy Volunteers | Yes | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | Not Provided | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT01181804 | ||||
Other Study ID Numbers ICMJE | P06992 | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product | Not Provided | ||||
IPD Sharing Statement |
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Responsible Party | Merck Sharp & Dohme Corp. | ||||
Study Sponsor ICMJE | Merck Sharp & Dohme Corp. | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE | Not Provided | ||||
PRS Account | Merck Sharp & Dohme Corp. | ||||
Verification Date | March 2017 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |