Hepatitis CPhase 1NCT01549496
A Drug Interaction Study of Boceprevir in Combination With Amlodipine or Diltiazem in Healthy Volunteers
A Phase 1 study testing Amlodipine and Diltiazem in people with Hepatitis C and Hypertension, run by Ottawa Hospital Research Institute at 1 site in Canada.
Trial summary
The purpose of this study is to evaluate the pharmacokinetic interactions between the hepatitis C NS3 protease inhibitor boceprevir and the calcium channel blockers amlodipine and diltiazem in healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Hepatitis C, Hypertension
- What is being tested?
- Amlodipine and Diltiazem
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteCanada
- Study dates
- May 2012to Sep 2012
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Able and willing to sign informed consent prior to any study-related activities.
- Male or female subjects between 18 and 65 years of age inclusive.
- Healthy, i.e. not suffering from a relevant acute or chronic illness.
- Body Mass Index (BMI) of 17.5 to 31 kg/m2; and a total body weight > 50 kg (110 lbs).
- Acceptable medical history, physical examination, and 12-lead ECG at screening.
- Acceptable laboratory values that indicate adequate baseline organ function at screening visit.
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- Willing to stop using any herbal or natural health products for 2 weeks prior to and during the study including: Grapefruit, grapefruit juice, St. John's Wort.
- Willingness to abstain from alcohol use for 3 days prior to and during the study.
- Female subject is either not of childbearing potential, defined as postmenopausal for at least 1 year or surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy), or is of childbearing potential and practicing one of the following methods of birth control:
- Condoms, sponge, foams, jellies, diaphragm or intrauterine device (IUD)
- A vasectomized partner
- Total abstinence from sexual intercourse
Who cannot join
- Have serological evidence of exposure to HIV or HCV.
- Known allergies to any of the study medications.
- Female subjects of childbearing potential who:
- Has a positive urine pregnancy test at screening.
- Is not willing to use a reliable method of barrier contraception during the study.
- Using only oral contraceptive as a birth control method.
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- Is breastfeeding.
- Inability to adhere to protocol.
- Use of any medications (2 weeks prior to or during the study) other than occasional use of acetaminophen.
- Female subjects using contraceptives that contain drospirenone.
- Subjects that are currently smoking.
- Subjects with hypertension or heart disease requiring medical treatment.
- Any condition possibly affecting drug absorption (e.g., gastro intestinal disorder).
- Patients may be excluded from the study for other reasons, at the investigator's discretion.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Clinical Investigation Unit, Ottawa Hospital Research Institute
Ottawa, Ontario, K1H8L6
About this study
Official title: A Drug Interaction Study Investigating the Effect of Boceprevir on the Pharmacokinetics of the Calcium Channel Blockers Amlodipine and Diltiazem and Vice Versa in Healthy Volunteers
The purpose of this study is to evaluate the pharmacokinetic interactions between the hepatitis C NS3 protease inhibitor boceprevir and the calcium channel blockers amlodipine and diltiazem in healthy volunteers.
- Conditions
- Hepatitis C, Hypertension
- Being tested
- Amlodipine, Diltiazem
- Keywords
- HCV, pharmacokinetics, boceprevir, hypertension, amlodipine, diltiazem
- Medical subject headings
- Hepatitis C, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AmlodipineDrug
amlodipine 2.5 mg QD
DiltiazemDrug
diltiazem 120 mg qd
| Study group | Role | What they receive |
|---|---|---|
| boceprevir | Experimental | boceprevir 800 mg tid Receives: Drug: Amlodipine; Drug: Diltiazem |
What is being measured
The primary outcome is the main question the study is designed to answer.
pharmacokinetics
AUC, Cmax, Cmin
Measured: 7 days
Secondary outcomes (1)
number of participants with adverse events
description and frequency of adverse events for all participants during the study
Measured: 29 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2012 (estimated)
- Study startMay 2012
- Primary completionSep 2012 (estimated)
Why it stopped: Investigator left this hospital
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis CStudies of the same condition, open and under way.
- More trials run by Ottawa Hospital Research InstituteThe 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
- Investigators
- Charles la Porte, PharmD, PhD, Principal investigator, Ottawa Hospital Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01549496
- Sponsor's protocol ID
- OHRI-BCP-CCB-2012
- Status last verified
- Jan 2015
- First submitted
- 1 Mar 2012
- Last updated
- 9 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Drug Interaction Study Investigating the Effect of Boceprevir on the Pharmacokinetics of the Calcium Channel Blockers Amlodipine and Diltiazem and Vice Versa in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT01549496
- Acronym / sponsor ID
- OHRI-BCP-CCB-2012
- Conditions
- Hepatitis C, Hypertension
- Keywords
- HCV, pharmacokinetics, boceprevir, hypertension, amlodipine, diltiazem
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Investigator left this hospital
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- May 2012
- Primary completion
- Sep 2012 (estimated)
- First posted
- 9 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the pharmacokinetic interactions between the hepatitis C NS3 protease inhibitor boceprevir and the calcium channel blockers amlodipine and diltiazem in healthy volunteers.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| boceprevir | Experimental | Drug: Amlodipine, Drug: Diltiazemboceprevir 800 mg tid |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Able and willing to sign informed consent prior to any study-related activities.
- Male or female subjects between 18 and 65 years of age inclusive.
- Healthy, i.e. not suffering from a relevant acute or chronic illness.
- Body Mass Index (BMI) of 17.5 to 31 kg/m2; and a total body weight > 50 kg (110 lbs).
- Acceptable medical history, physical examination, and 12-lead ECG at screening.
Key exclusion criteria (14 listed)
- Have serological evidence of exposure to HIV or HCV.
- Known allergies to any of the study medications.
- Female subjects of childbearing potential who:
- Inability to adhere to protocol.
- Use of any medications (2 weeks prior to or during the study) other than occasional use of acetaminophen.
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 |
|---|---|---|
| Amlodipineamlodipine 2.5 mg QD | Drug | boceprevir |
| Diltiazemdiltiazem 120 mg qd | Drug | boceprevir |
Primary outcome
pharmacokinetics
Time frame: 7 days
AUC, Cmax, Cmin
1 secondary outcome
number of participants with adverse events
Time frame: 29 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2015.
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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.
Charles la Porte, PharmD, PhD principal investigator
Ottawa Hospital Research Institute
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 Amlodipine and Diltiazem in people with Hepatitis C and Hypertension, run by Ottawa Hospital Research Institute at 1 site in Canada.
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 12 inclusion and 14 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: withdrawn, as of the sponsor's last update on 9 Jan 2015. 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 Canada. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
pharmacokinetics (time frame: 7 days). 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 9 Jan 2015.