NCT01549496

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 1, 2012

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 9, 2012

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2012

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
Last Updated

January 9, 2015

Status Verified

January 1, 2015

Enrollment Period

4 months

First QC Date

March 1, 2012

Last Update Submit

January 7, 2015

Conditions

Hepatitis CHypertension

Keywords

HCVpharmacokineticsboceprevirhypertensionamlodipinediltiazem

Outcome Measures

Primary Outcomes (1)

  • pharmacokinetics

    AUC, Cmax, Cmin

    7 days

Secondary Outcomes (1)

  • number of participants with adverse events

    29 days

Study Arms (1)

boceprevir

EXPERIMENTAL

boceprevir 800 mg tid

Drug: AmlodipineDrug: Diltiazem

Interventions

AmlodipineDRUG

amlodipine 2.5 mg QD

boceprevir
DiltiazemDRUG

diltiazem 120 mg qd

boceprevir

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Investigation Unit, Ottawa Hospital Research Institute

Ottawa, Ontario, K1H8L6, Canada

Location

Related Links

MeSH Terms

Conditions

Hepatitis CHypertension

Interventions

AmlodipineDiltiazem

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitisLiver DiseasesDigestive System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

DihydropyridinesPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Charles la Porte, PharmD, PhD

    Ottawa Hospital Research Institute

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 1, 2012

First Posted

March 9, 2012

Study Start

May 1, 2012

Primary Completion

September 1, 2012

Last Updated

January 9, 2015

Record last verified: 2015-01

Locations

CA(1)