Hepatitis CPhase 1NCT01499498
The Boceprevir and Sildenafil Pharmacokinetics Study
A Phase 1 study testing Sildenafil and Boceprevir in people with Hepatitis C, run by Imperial College London at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Hepatitis C
- What is being tested?
- Sildenafil and Boceprevir
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Dec 2012to May 2014
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- The ability to understand and sign a written informed consent form, prior to participation in any screening procedures and must be willing to comply with all study requirements.
- Subjects in good health upon medical history, physical exam, and laboratory testing and BMI <32.
- Subjects who are heterosexually active must use two forms of barrier contraception (e.g., condom with spermicide) during heterosexual intercourse, from screening through completion of the study including 10 days following last dose of study drug.
- Have no serologic evidence of HIV or HCV infection through antibody testing at screening.
- Have screening laboratory results (haematology, chemistry) that fall within the normal range of the central laboratory's reference ranges unless the results have been determined by the Investigator to have no clinical relevance
Who cannot join
- Any serious or active medical or psychiatric illness which, in the opinion of the Investigator, would interfere with subject treatment, assessment, or compliance with the protocol. This would include any active clinically significant renal, cardiac, hepatic, pulmonary, vascular, metabolic (thyroid disorders, adrenal disease), immunodeficiency disorders, active infection, or malignancy.
- Previous participation in an investigational trial involving administration of any investigational compound within 1 month prior to the study screening.
- Clinically relevant alcohol or drug use (positive drug screen) or history of alcohol or drug use considered by the Investigator to be sufficient to hinder compliance with treatment, follow-up procedures or evaluation of adverse events. Smoking is permitted, but tobacco intake should remain consistent throughout the study.
- Any medication taken listed in protocol including over-the-counter medications and herbal products within 21 days of commencing study drug dosing with the exception of vitamins and/or paracetamol. When a concomitant medication is necessary, this will be reviewed by the Investigator and if not contraindicated, may be continued at the same dose and frequency during the study period.
- History of drug sensitivity or drug allergy which in the opinion of the investigator may put the subject at increased risk of drug reactions during the study.
- Subjects with female partners who are pregnant will not be allowed to enter the study
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Imperial College Healthcare NHS Trust
London, W2 1NY
About this study
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
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.
Read the 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: predose,0.5, 1, 2, 3, 4, 6, 8, 10,12 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: predose,0.5, 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: predose,0.5, 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.
- Conditions
- Hepatitis C
- Being tested
- Sildenafil and Boceprevir
- Keywords
- Healthy volunteers
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sildenafil and BoceprevirDrug
Also called Viagra and Victrelis
25mg once/800mg three times a day
| Study group | Role | What they receive |
|---|---|---|
| Sildenafil and Boceprevir | Experimental | Healthy volunteers Receives: Drug: Sildenafil and Boceprevir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sildenafil Alone Maximum Plasma Concentration
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)
Measured: Day 1
Boceprevir Alone Maximum Plasma Concentration
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)
Measured: day 10-15
Sildenafil Maximum Plasma Concentration
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)
Measured: Day 16
Boceprevir Maximum Plasma Concentration
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)
Measured: Day 16
Secondary outcomes (1)
Number of Patients With Adverse Events
The number of repeated adverse events will be used to assess the safety of the drugs in combination
Measured: Day 1 - 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2011 (estimated)
- Study startDec 2012
- Primary completionApr 2013
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Hepatitis CStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alan Winston, MBChB MD, Principal investigator, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01499498
- Sponsor's protocol ID
- BOC_PK
- Status last verified
- Jun 2019
- First submitted
- 4 Nov 2011
- Last updated
- 21 Jun 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01499498
- Acronym / sponsor ID
- BOC_PK
- Conditions
- Hepatitis C
- Keywords
- Healthy volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Apr 2013 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 26 Dec 2011 (estimated)
- Results
- Posted 7 Nov 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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: predose,0.5, 1, 2, 3, 4, 6, 8, 10,12 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: predose,0.5, 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: predose,0.5, 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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sildenafil and Boceprevir | Experimental | Drug: Sildenafil and BoceprevirHealthy volunteers |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- The ability to understand and sign a written informed consent form, prior to participation in any screening procedures and must be willing to comply with all study requirements.
- Subjects in good health upon medical history, physical exam, and laboratory testing and BMI <32.
- Subjects who are heterosexually active must use two forms of barrier contraception (e.g., condom with spermicide) during heterosexual intercourse, from screening through completion of the study including 10 days following last dose of study drug.
- Have no serologic evidence of HIV or HCV infection through antibody testing at screening.
- Have screening laboratory results (haematology, chemistry) that fall within the normal range of the central laboratory's reference ranges unless the results have been determined by the Investigator to have no clinical relevance
Key exclusion criteria (6 listed)
- Any serious or active medical or psychiatric illness which, in the opinion of the Investigator, would interfere with subject treatment, assessment, or compliance with the protocol. This would include any active clinically significant renal, cardiac, hepatic, pulmonary, vascular, metabolic (thyroid disorders, adrenal disease), immunodeficiency disorders, active infection, or malignancy.
- Previous participation in an investigational trial involving administration of any investigational compound within 1 month prior to the study screening.
- Clinically relevant alcohol or drug use (positive drug screen) or history of alcohol or drug use considered by the Investigator to be sufficient to hinder compliance with treatment, follow-up procedures or evaluation of adverse events. Smoking is permitted, but tobacco intake should remain consistent throughout the study.
- Any medication taken listed in protocol including over-the-counter medications and herbal products within 21 days of commencing study drug dosing with the exception of vitamins and/or paracetamol. When a concomitant medication is necessary, this will be reviewed by the Investigator and if not contraindicated, may be continued at the same dose and frequency during the study period.
- History of drug sensitivity or drug allergy which in the opinion of the investigator may put the subject at increased risk of drug reactions during the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sildenafil and BoceprevirAlso: Viagra and Victrelis25mg once/800mg three times a day | Drug | Sildenafil and Boceprevir |
Primary outcome
Sildenafil Alone Maximum Plasma Concentration
Time frame: Day 1
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)
Boceprevir Alone Maximum Plasma Concentration
Time frame: day 10-15
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)
Sildenafil Maximum Plasma Concentration
Time frame: Day 16
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)
Boceprevir Maximum Plasma Concentration
Time frame: Day 16
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)
1 secondary outcome
Number of Patients With Adverse Events
Time frame: Day 1 - 16
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alan Winston, MBChB MD principal investigator
Imperial College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Sildenafil and Boceprevir in people with Hepatitis C, run by Imperial College London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Nov 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sildenafil Alone Maximum Plasma Concentration (time frame: Day 1). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2019.