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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01549496
Recruitment Status : Withdrawn (Investigator left this hospital)
First Posted : March 9, 2012
Last Update Posted : January 9, 2015
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Ottawa Hospital Research Institute

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.

Condition or disease Intervention/treatment Phase
Hepatitis C Hypertension Drug: Amlodipine Drug: Diltiazem Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : May 2012
Estimated Primary Completion Date : September 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drug Reactions

Arm Intervention/treatment
Experimental: boceprevir
boceprevir 800 mg tid
Drug: Amlodipine
amlodipine 2.5 mg QD

Drug: Diltiazem
diltiazem 120 mg qd

Primary Outcome Measures :
  1. pharmacokinetics [ Time Frame: 7 days ]
    AUC, Cmax, Cmin

Secondary Outcome Measures :
  1. number of participants with adverse events [ Time Frame: 29 days ]
    description and frequency of adverse events for all participants during the study

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01549496

Canada, Ontario
Clinical Investigation Unit, Ottawa Hospital Research Institute
Ottawa, Ontario, Canada, K1H8L6
Sponsors and Collaborators
Ottawa Hospital Research Institute
Merck Sharp & Dohme Corp.
Principal Investigator: Charles la Porte, PharmD, PhD Ottawa Hospital Research Institute

Responsible Party: Ottawa Hospital Research Institute Identifier: NCT01549496     History of Changes
Other Study ID Numbers: OHRI-BCP-CCB-2012
First Posted: March 9, 2012    Key Record Dates
Last Update Posted: January 9, 2015
Last Verified: January 2015

Keywords provided by Ottawa Hospital Research Institute:

Additional relevant MeSH terms:
Hepatitis C
Vascular Diseases
Cardiovascular Diseases
Hepatitis, Viral, Human
Virus Diseases
Flaviviridae Infections
RNA Virus Infections
Liver Diseases
Digestive System Diseases
Calcium Channel Blockers
Antihypertensive Agents
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents