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The Boceprevir and Sildenafil Pharmacokinetics Study

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ClinicalTrials.gov Identifier: NCT01499498
Recruitment Status : Completed
First Posted : December 26, 2011
Results First Posted : November 7, 2014
Last Update Posted : June 21, 2019
Sponsor:
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
Enrollment 13
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Sildenafil and Boceprevir
Hide Arm/Group Description

Healthy volunteers

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

Period Title: Overall Study
Started 13
Completed 13
Not Completed 0
Arm/Group Title Sildenafil and Boceprevir
Hide Arm/Group Description 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
Overall Number of Baseline Participants 13
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 13 participants
36
(22 to 47)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants
Female
0
   0.0%
Male
13
 100.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 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  
Median (Full Range)
Unit of measure:  Kg/m2
Number Analyzed 13 participants
26.2
(19.9 to 30.6)
1.Primary Outcome
Title Sildenafil Alone Maximum Plasma Concentration
Hide Description Single dose sildenafil 25mg will be administered with food. Intensive pharmacokinetic sampling will be taken over a 24 hour period (0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 and 24 hours post dose)
Time Frame Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sildenafil Only
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Healthy volunteers

Sildenafil 25mg once

Overall Number of Participants Analyzed 13
Geometric Mean (95% Confidence Interval)
Unit of Measure: ng/mL
79.9
(59.9 to 106.5)
2.Primary Outcome
Title Boceprevir Alone Maximum Plasma Concentration
Hide Description Day 10 commence BOC 800mg three times a day with food. On day 15 at steady state, subjects will attend for witnessed dosing and an intensive pharmacokinetic visit over 8 hours (samples drawn 0, 0.5, 1, 2, 3, 4, 6 and 8 hours post dose)
Time Frame day 10-15
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Bocepreprivir Alone
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Healthy volunteers

Boceprevir: 800mg three times a day

Overall Number of Participants Analyzed 13
Geometric Mean (95% Confidence Interval)
Unit of Measure: ng/mL
1432.5
(1276.1 to 1607.7)
3.Primary Outcome
Title Sildenafil Maximum Plasma Concentration
Hide Description administer BOC 800mg and single dose sildenafil 25mg with food. Intensive pharmacokinetic sampling will be taken over a 24 hour period (0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 and 24 hours post dose)
Time Frame Day 16
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sildenafil and Boceprevir
Hide Arm/Group Description:

Healthy volunteers

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

Overall Number of Participants Analyzed 13
Geometric Mean (95% Confidence Interval)
Unit of Measure: ng/mL
150.9
(126.2 to 180.5)
4.Primary Outcome
Title Boceprevir Maximum Plasma Concentration
Hide Description administer BOC 800mg and single dose sildenafil 25mg with food. Intensive pharmacokinetic sampling will be taken over a 24 hour period (0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 and 24 hours post dose)
Time Frame Day 16
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sildenafil and Boceprevir
Hide Arm/Group Description:

Healthy volunteers

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

Overall Number of Participants Analyzed 13
Geometric Mean (95% Confidence Interval)
Unit of Measure: ng/mL
1440.5
(1211.7 to 1712.4)
5.Secondary Outcome
Title Number of Patients With Adverse Events
Hide Description The number of repeated adverse events will be used to assess the safety of the drugs in combination
Time Frame Day 1 - 16
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sildenafil and Boceprevir
Hide Arm/Group Description:

Healthy volunteers

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

Overall Number of Participants Analyzed 13
Measure Type: Number
Unit of Measure: participants
0
Time Frame 16 days
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Sildenafil and Boceprevir
Hide Arm/Group Description

Healthy volunteers

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

All-Cause Mortality
Sildenafil and Boceprevir
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Sildenafil and Boceprevir
Affected / at Risk (%)
Total   0/13 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Sildenafil and Boceprevir
Affected / at Risk (%)
Total   0/13 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr Borja Mora Peris
Organization: Imperial College London
Phone: 020 3312 6789
EMail: b.mora-peris@imperial.ac.uk
Layout table for additonal information
Responsible Party: Imperial College London
ClinicalTrials.gov 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: June 21, 2019