CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 13 enrolled
Drug / intervention
Sildenafil and Boceprevirdrug
Likely dose
Sildenafil and Boceprevir 25mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01499498
NCT01499498Phase 1Completed

A Phase I Study to Assess the Safety, Tolerability and Pharmacokinetic Profile of Boceprevir and Sildenafil When Dosed Separately and Together in Healthy Male Volunteers

Imperial College London·interventional·Posted Dec 26, 2011·Updated Jun 21, 2019

In Brief

A Phase 1 clinical trial evaluating Sildenafil and Boceprevir for Hepatitis C. Completed, enrolled 13 participants across 1 site.

Detailed Summary

This is a healthy volunteer study looking at the interactions between two drugs: boceprevir and sildenafil. New drugs are being developed to treat people with the chronic viral infection hepatitis C. Very little is know how these new treatments interact with other medications such as the drugs used to treat erectile dysfunction. The purpose of this study is to look at levels of both a new hepatitis C drug called boceprevir (BOC) and an existing erectile dysfunction drug called sildenafil to see if they affect the blood levels of each other when given separately and together.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatitis C
CountriesUnited Kingdom
Collaborators--

Timeline

Phase 1CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedDec 26, 2011
Enrollment StartDec 1, 2012
Primary CompletionApr 1, 2013
Study CompletionMay 1, 2014
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 14.5 years ago

Interventions

Sildenafil and Boceprevirdrug

25mg once/800mg three times a day