Clinical trial NCT01549496: A Drug Interaction Study of Boceprevir in Combination With Amlodipine or Diltiazem in Healthy Volunteers
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 type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Hepatitis C
Hypertension
Keywords: HCV
pharmacokinetics
boceprevir
hypertension
amlodipine
diltiazem
Lead sponsor: Ottawa Hospital Research Institute
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2012-03-09
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: pharmacokinetics
timeFrame: 7 days
Secondary outcomes:
measure: number of participants with adverse events
timeFrame: 29 days
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: Clinical Investigation Unit, Ottawa Hospital Research Institute
state: Ontario
Study officials:
affiliation: Ottawa Hospital Research Institute
name: Charles la Porte, PharmD, PhD
role: PRINCIPAL_INVESTIGATOR
References: