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

Phase 1

Withdrawn

• Conditions: Hepatitis C; Hypertension
• Interventions: Drug: Amlodipine; Drug: Diltiazem

• Registration Number: NCT01549496
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-03-01
• Study First Submitted QC: 2012-03-08
• Study First Posted: 2012-03-09
• Study Start: 2012-05
• Primary Completion: 2012-09
• Status Verified: 2015-01
• Last Update Submitted: 2015-01-07
• Last Update Posted: 2015-01-09

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
boceprevir	Diltiazem	boceprevir 800 mg tid
boceprevir	Amlodipine	boceprevir 800 mg tid

Primary Outcome Measures

Name	Time	Method
pharmacokinetics	7 days	AUC, Cmax, Cmin

Secondary Outcome Measures

Name	Time	Method
number of participants with adverse events	29 days	description and frequency of adverse events for all participants during the study

Trial Locations

Locations (1)

Clinical Investigation Unit, Ottawa Hospital Research Institute; 🇨🇦 Ottawa, Ontario, Canada