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

Sponsor

Ottawa Hospital Research Institute (Other)

Overall Status

Withdrawn

CT.gov ID

NCT01549496

Collaborator

Merck Sharp & Dohme LLC (Industry)

Enrollment

Location

Arm

Study Details

Study Description

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 Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

N/A

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 1, 2012

Anticipated Primary Completion Date :

Sep 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: boceprevir boceprevir 800 mg tid	Drug: Amlodipine amlodipine 2.5 mg QD Drug: Diltiazem diltiazem 120 mg qd

Arm

Intervention/Treatment

Experimental: boceprevir

boceprevir 800 mg tid

Drug: Amlodipine

amlodipine 2.5 mg QD

Drug: Diltiazem

diltiazem 120 mg qd

Outcome Measures

Primary Outcome Measures

pharmacokinetics [7 days]
AUC, Cmax, Cmin

Secondary Outcome Measures

number of participants with adverse events [29 days]
description and frequency of adverse events for all participants during the study

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Able and willing to sign informed consent prior to any study-related activities.
Male or female subjects between 18 and 65 years of age inclusive.
Healthy, i.e. not suffering from a relevant acute or chronic illness.
Body Mass Index (BMI) of 17.5 to 31 kg/m2; and a total body weight > 50 kg (110 lbs).
Acceptable medical history, physical examination, and 12-lead ECG at screening.
Acceptable laboratory values that indicate adequate baseline organ function at screening visit.
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.
Willingness to abstain from alcohol use for 3 days prior to and during the study.
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:

Have serological evidence of exposure to HIV or HCV.
Known allergies to any of the study medications.
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.

Inability to adhere to protocol.
Use of any medications (2 weeks prior to or during the study) other than occasional use of acetaminophen.
Female subjects using contraceptives that contain drospirenone.
Subjects that are currently smoking.
Subjects with hypertension or heart disease requiring medical treatment.
Any condition possibly affecting drug absorption (e.g., gastro intestinal disorder).
Patients may be excluded from the study for other reasons, at the investigator's discretion.