Hepatitis C, Hypertension
Conditions
Keywords
HCV, pharmacokinetics, boceprevir, hypertension, amlodipine, diltiazem
Brief 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.
Interventions
DRUGAmlodipine
amlodipine 2.5 mg QD
DRUGDiltiazem
diltiazem 120 mg qd
Sponsors
Merck Sharp & Dohme LLC
Ottawa Hospital Research Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| pharmacokinetics | 7 days | AUC, Cmax, Cmin |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| number of participants with adverse events | 29 days | description and frequency of adverse events for all participants during the study |
Countries
Canada
Outcome results
None listed