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The Boceprevir and Sildenafil Pharmacokinetics Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Imperial College London
ClinicalTrials.gov Identifier:
NCT01499498
First received: November 4, 2011
Last updated: November 6, 2014
Last verified: October 2014
Results First Received: October 9, 2014  
Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Hepatitis C
Intervention: Drug: Sildenafil and 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
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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
Sildenafil and Boceprevir

Healthy volunteers

Sildenafil and Boceprevir : 25mg once daily/800mg three times a day


Participant Flow:   Overall Study
    Sildenafil and Boceprevir  
STARTED     13  
COMPLETED     13  
NOT COMPLETED     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.
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Reporting Groups
  Description
Sildenafil and Boceprevir All subjects take single dose sildenafil 25mg day 0, day 10-15 they take boceprevir 800mg three times a day followed by Intentive PK on day 15 and on day 16 single dose of sildenafil and boceprevir together followed by intensive PK

Baseline Measures
    Sildenafil and Boceprevir  
Number of Participants  
[units: participants]
  13  
Age  
[units: years]
Median ( Full Range )
  36  
  ( 22 to 47 )  
Gender  
[units: participants]
 
Female     0  
Male     13  
Race (NIH/OMB)  
[units: participants]
 
American Indian or Alaska Native     0  
Asian     4  
Native Hawaiian or Other Pacific Islander     0  
Black or African American     3  
White     6  
More than one race     0  
Unknown or Not Reported     0  
Body Mass Index  
[units: kg/m2]
Median ( Full Range )
  26.2  
  ( 19.9 to 30.6 )  



  Outcome Measures
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1.  Primary:   Sildenafil Alone Maximum Plasma Concentration   [ Time Frame: Day 1 ]

2.  Primary:   Boceprevir Alone Maximum Plasma Concentration   [ Time Frame: day 10-15 ]

3.  Primary:   Sildenafil Maximum Plasma Concentration   [ Time Frame: Day 16 ]

4.  Primary:   Boceprevir Maximum Plasma Concentration   [ Time Frame: Day 16 ]

5.  Secondary:   Number of Patients With Adverse Events   [ Time Frame: Day 1 - 16 ]


  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:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr Borja Mora Peris
Organization: Imperial College London
phone: 020 3312 6789
e-mail: b.mora-peris@imperial.ac.uk


No publications provided


Responsible Party: Imperial College London
ClinicalTrials.gov Identifier: NCT01499498     History of Changes
Other Study ID Numbers: BOC_PK
Study First Received: November 4, 2011
Results First Received: October 9, 2014
Last Updated: November 6, 2014
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency