A Drug Interaction Study of Boceprevir in Combination With Amlodipine or Diltiazem in Healthy Volunteers
Information source: Ottawa Hospital Research Institute
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hepatitis C; Hypertension
Intervention: Amlodipine (Drug); Diltiazem (Drug)
Phase: Phase 1
Status: Withdrawn
Sponsored by: Ottawa Hospital Research Institute Official(s) and/or principal investigator(s):
Charles la Porte, PharmD, PhD, Principal Investigator, Affiliation: Ottawa Hospital Research Institute
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.
Clinical Details
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
Study design: Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: pharmacokinetics
Secondary outcome: number of participants with adverse events
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
1. Able and willing to sign informed consent prior to any study-related activities.
2. Male or female subjects between 18 and 65 years of age inclusive.
3. Healthy, i. e. not suffering from a relevant acute or chronic illness.
4. Body Mass Index (BMI) of 17. 5 to 31 kg/m2; and a total body weight > 50 kg (110 lbs).
5. Acceptable medical history, physical examination, and 12-lead ECG at screening.
6. Acceptable laboratory values that indicate adequate baseline organ function at
screening visit.
7. 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.
8. Willingness to abstain from alcohol use for 3 days prior to and during the study.
9. 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
Exclusion Criteria:
1. Have serological evidence of exposure to HIV or HCV.
2. Known allergies to any of the study medications.
3. 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.
- Is breastfeeding.
4. Inability to adhere to protocol.
5. Use of any medications (2 weeks prior to or during the study) other than occasional
use of acetaminophen.
6. Female subjects using contraceptives that contain drospirenone.
7. Subjects that are currently smoking.
8. Subjects with hypertension or heart disease requiring medical treatment.
9. Any condition possibly affecting drug absorption (e. g., gastro intestinal disorder).
10. Patients may be excluded from the study for other reasons, at the investigator's
discretion.
Locations and Contacts
Clinical Investigation Unit, Ottawa Hospital Research Institute, Ottawa, Ontario K1H8L6, Canada
Additional Information
Info on Clinical Investigation Unit
Starting date: May 2012
Last updated: January 7, 2015
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