Ignite Creation Date:
2024-05-06 @ 12:08 AM
Last Modification Date:
2024-10-26 @ 10:45 AM
Study NCT ID:
NCT01499498
Status:
COMPLETED
Last Update Posted:
2019-06-21
First Post:
2011-11-04
Brief Title:
The Boceprevir and Sildenafil Pharmacokinetics Study
Sponsor:
Imperial College London
Organization:
Imperial College London
Study Overview
Official Title:
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
Status:
COMPLETED
Status Verified Date:
2019-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Detailed Description:
Total duration for each participant will be up to 40 days plus a screening visit 1 - 3 weeks prior to the start of the study
They will visit the clinic on 10 occasions screening visit baseline visit day 0 day 1 a visit between day 4 and 7 day 10 day 14 day 15 day 16 day 17 and a follow up visit between days 26 and 40
The total amount of blood collected from participants during the entire study will be no greater than 350 ml in total around 23 tablespoons
At the screening visit a clinical assessment will be performed At the baseline visit participants will attend the clinic fasted and will be required to remain on the unit for approximately 14 hours
On the morning of the visit clinical assessments will be performed Sildenafil 25mg 1 tablet will be administered with a standardised meal Blood samples will be taken at the following times in order to measure the levels of sildenafil in the blood predose05 1 2 3 4 6 8 1012 and 24 hours post dose
On day Day 10 boceprevir will be initiated 800mg 4 capsules 3 times a day for the next 4 days on day 14 the participants will attend the clinic for a witnessed dose of boceprevir and safety assessment
On day 15 the participants will attend for their 2nd long visit 10 hours when they will be administered boceprevir BOC 800mg 4 capsules with a standardised meal then have blood samples taken at the following times in order to measure the levels of BOC in the blood predose05 1 2 3 4 6 and 8 hours post dose
After the 8 hour blood collection participants will be administered boceprevir BOC 800mg 4 capsules with food and they will self administer BOC 800mg 4 capsules with food at home 8 hours later
On day 16 participants will attend for the 3rd long visit 14 hours where they will be administered boceprevir BOC 800mg 4 capsules and sildenafil 25mg with a standardised meal Blood samples will be taken at the following times in order to measure the levels of both BOC and sildenafil in the blood predose05 1 2 3 4 6 and 8 hours post dose
After the 8 hour blood collection participants will be administered boceprevir BOC 800mg 4 capsules with food and will then self administer BOC 800mg 4 capsules with food at home 8 hours later This will be their last dose of study medication They will return the next day for a final blood test post 24 hours A final visit between days 26 and 40 will be performed including clinical assessments
They will visit the clinic on 10 occasions screening visit baseline visit day 0 day 1 a visit between day 4 and 7 day 10 day 14 day 15 day 16 day 17 and a follow up visit between days 26 and 40
The total amount of blood collected from participants during the entire study will be no greater than 350 ml in total around 23 tablespoons
At the screening visit a clinical assessment will be performed At the baseline visit participants will attend the clinic fasted and will be required to remain on the unit for approximately 14 hours
On the morning of the visit clinical assessments will be performed Sildenafil 25mg 1 tablet will be administered with a standardised meal Blood samples will be taken at the following times in order to measure the levels of sildenafil in the blood predose05 1 2 3 4 6 8 1012 and 24 hours post dose
On day Day 10 boceprevir will be initiated 800mg 4 capsules 3 times a day for the next 4 days on day 14 the participants will attend the clinic for a witnessed dose of boceprevir and safety assessment
On day 15 the participants will attend for their 2nd long visit 10 hours when they will be administered boceprevir BOC 800mg 4 capsules with a standardised meal then have blood samples taken at the following times in order to measure the levels of BOC in the blood predose05 1 2 3 4 6 and 8 hours post dose
After the 8 hour blood collection participants will be administered boceprevir BOC 800mg 4 capsules with food and they will self administer BOC 800mg 4 capsules with food at home 8 hours later
On day 16 participants will attend for the 3rd long visit 14 hours where they will be administered boceprevir BOC 800mg 4 capsules and sildenafil 25mg with a standardised meal Blood samples will be taken at the following times in order to measure the levels of both BOC and sildenafil in the blood predose05 1 2 3 4 6 and 8 hours post dose
After the 8 hour blood collection participants will be administered boceprevir BOC 800mg 4 capsules with food and will then self administer BOC 800mg 4 capsules with food at home 8 hours later This will be their last dose of study medication They will return the next day for a final blood test post 24 hours A final visit between days 26 and 40 will be performed including clinical assessments
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None