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

This study is not yet open for participant recruitment.
Verified March 2012 by Ottawa Hospital Research Institute
Sponsor:
Collaborator:
Merck
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
History of Changes
  Purpose

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 Intervention Phase
Hepatitis C
Hypertension
 Drug: Amlodipine
Drug: Diltiazem
 Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Ottawa Hospital Research Institute:

Primary Outcome Measures:
  • pharmacokinetics [ Time Frame: 7 days ] [ Designated as safety issue: No ]
    AUC, Cmax, Cmin


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 24
Study Start Date: May 2012
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: boceprevir
boceprevir 800 mg tid
 Drug: Amlodipine
amlodipine 2.5 mg QD
Drug: Diltiazem
diltiazem 120 mg qd

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01549496

Locations
Canada, Ontario
Clinical Investigation Unit, Ottawa Hospital Research Institute
Ottawa, Ontario, Canada, K1H8L6
Sponsors and Collaborators
Ottawa Hospital Research Institute
Merck
Investigators
Principal Investigator: Charles la Porte, PharmD, PhD Ottawa Hospital Research Institute
  More Information

Additional Information:
Info on Clinical Investigation Unit  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier: NCT01549496     History of Changes
Other Study ID Numbers: OHRI-BCP-CCB-2012
Study First Received: March 1, 2012
Last Updated: March 8, 2012
Health Authority: Canada: Ethics Review Committee
Canada: Health Canada

Keywords provided by Ottawa Hospital Research Institute:
HCV
pharmacokinetics
boceprevir
 hypertension
amlodipine
diltiazem

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Hypertension
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Vascular Diseases
 Cardiovascular Diseases
Calcium Channel Blockers
Diltiazem
Verapamil
Amlodipine
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses
Antihypertensive Agents
Vasodilator Agents
Anti-Arrhythmia Agents

ClinicalTrials.gov processed this record on May 22, 2013