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WithdrawnNCT01549496Updated Jan 9, 2015

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

A Phase 1 interventional study of Amlodipine and Diltiazem in Hepatitis C and Hypertension, sponsored by Ottawa Hospital Research Institute. Withdrawn at 1 site in Canada. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-01-09.

Sponsored by Ottawa Hospital Research Institute · Phase 1, Interventional, and Treatment

Why this study was withdrawn
Investigator left this hospital
Phase
Phase 1
Study type
Interventional
Enrollment
0
Allocation
Not applicable
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Hepatitis C
  • Hypertension

Keywords

  • HCV
  • pharmacokinetics
  • boceprevir
  • hypertension
  • amlodipine
  • diltiazem
03

In context

Hepatitis C

2,321 studies on the registry are indexed under Hepatitis C; 102 are open to participants now.

Browse Hepatitis C studies →

Lead sponsor

Ottawa Hospital Research Institute is the lead sponsor of 538 studies on the registry; 100 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
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

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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    boceprevir

    boceprevir 800 mg tid

    Drug: Amlodipine · Drug: Diltiazem

Interventions

  • DrugAmlodipine

    amlodipine 2.5 mg QD

  • DrugDiltiazem

    diltiazem 120 mg qd

06

What researchers measure

Primary outcomes

  1. pharmacokinetics

    AUC, Cmax, Cmin

    Time frame: 7 days

Secondary outcomes

  1. number of participants with adverse events

    description and frequency of adverse events for all participants during the study

    Time frame: 29 days

07

Study locations

1 site
  • Clinical Investigation Unit, Ottawa Hospital Research Institute
    Ottawa, Ontario K1H8L6, Canada
08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 9, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01549496
Lead sponsor
Ottawa Hospital Research Institute
Collaborators
Merck Sharp & Dohme LLC
Responsible party
Sponsor
First posted
Mar 9, 2012
Start date
May 2012
Primary completion
Sep 2012 (estimated)
Last update
Jan 9, 2015

Study contacts

Charles la Porte, PharmD, PhD
principal investigator · Ottawa Hospital Research Institute

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Jan 2015. You cannot join it, but the record below documents what was studied.

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