The Boceprevir and Sildenafil Pharmacokinetics Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01499498
Recruitment Status : Completed
First Posted : December 26, 2011
Results First Posted : November 7, 2014
Last Update Posted : December 8, 2016
Information provided by (Responsible Party):
Imperial College London

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Hepatitis C
Intervention: Drug: Sildenafil and Boceprevir

  Participant Flow

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
Sildenafil and Boceprevir

Healthy volunteers

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

Participant Flow:   Overall Study
    Sildenafil and Boceprevir

  Baseline Characteristics

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
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 
Overall Participants Analyzed 
[Units: Participants]
[Units: Years]
Median (Full Range)
 (22 to 47) 
[Units: Participants]
Count of Participants
Female      0   0.0% 
Male      13 100.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
American Indian or Alaska Native      0   0.0% 
Asian      4  30.8% 
Native Hawaiian or Other Pacific Islander      0   0.0% 
Black or African American      3  23.1% 
White      6  46.2% 
More than one race      0   0.0% 
Unknown or Not Reported      0   0.0% 
Body Mass Index 
[Units: Kg/m2]
Median (Full Range)
 (19.9 to 30.6) 

  Outcome Measures

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

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

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

Responsible Party: Imperial College London Identifier: NCT01499498     History of Changes
Other Study ID Numbers: BOC_PK
First Submitted: November 4, 2011
First Posted: December 26, 2011
Results First Submitted: October 9, 2014
Results First Posted: November 7, 2014
Last Update Posted: December 8, 2016