A Drug Interaction Study of Boceprevir in Combination With Amlodipine or Diltiazem in Healthy Volunteers

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2012 by Ottawa Hospital Research Institute.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier:
NCT01549496
First received: March 1, 2012
Last updated: March 8, 2012
Last verified: March 2012

March 1, 2012
March 8, 2012
May 2012
September 2012   (final data collection date for primary outcome measure)
pharmacokinetics [ Time Frame: 7 days ] [ Designated as safety issue: No ]
AUC, Cmax, Cmin
Same as current
Complete list of historical versions of study NCT01549496 on ClinicalTrials.gov Archive Site
number of participants with adverse events [ Time Frame: 29 days ] [ Designated as safety issue: Yes ]
description and frequency of adverse events for all participants during the study
Same as current
Not Provided
Not Provided
 
A Drug Interaction Study of Boceprevir in Combination With Amlodipine or Diltiazem in Healthy Volunteers
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.

Not Provided
Interventional
Phase 1
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Hepatitis C
  • Hypertension
  • Drug: Amlodipine
    amlodipine 2.5 mg QD
  • Drug: Diltiazem
    diltiazem 120 mg qd
Experimental: boceprevir
boceprevir 800 mg tid
Interventions:
  • Drug: Amlodipine
  • Drug: Diltiazem
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
24
Not Provided
September 2012   (final data collection date for primary outcome measure)

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.
Both
18 Years to 65 Years
Yes
Canada
 
NCT01549496
OHRI-BCP-CCB-2012
No
Ottawa Hospital Research Institute
Ottawa Hospital Research Institute
Merck Sharp & Dohme Corp.
Principal Investigator: Charles la Porte, PharmD, PhD Ottawa Hospital Research Institute
Ottawa Hospital Research Institute
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP