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

Hypertension Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01549496
• Other study ID #: OHRI-BCP-CCB-2012
• Status: Withdrawn
• Phase: Phase 1
• First received: March 1, 2012
• Last updated: January 7, 2015
• Start date: May 2012

Study information

• Verified date: January 2015
• Source: Ottawa Hospital Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review CommitteeCanada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. primary completion date: September 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hepatitis C
• Hypertension

Intervention

Drug:
• Amlodipine
amlodipine 2.5 mg QD
• Diltiazem
diltiazem 120 mg qd

Locations

Country	Name	City	State
Canada	Clinical Investigation Unit, Ottawa Hospital Research Institute	Ottawa	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Ottawa Hospital Research Institute	Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pharmacokinetics	AUC, Cmax, Cmin	7 days	No
Secondary	number of participants with adverse events	description and frequency of adverse events for all participants during the study	29 days	Yes