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Safety Study of Mibefradil When Given Four Times a Day in Healthy Volunteers

NCT01550458 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2019-04-08

No results posted yet for this study

Summary

The objective of the study is to determine the safety and pharmacokinetics of a 7 day course of oral mibefradil given four times a day in healthy volunteers. This is a dose escalation study in which the total daily dose of mibefradil will be increased with each cohort.

Conditions

  • Healthy

Interventions

DRUG

mibefradil

25 mg tablets for oral administration given for 7 days at a total daily dose beginning at 100 mg per day divided into four doses. Doses will be incremented in successive cohorts by 25 mg/day up to 400 mg/day.

OTHER

Placebo

1 out of 6 patients per cohort will receive placebo tablets identical in appearance and number to the active mibefradil arm.

Sponsors & Collaborators

  • Celerion

    collaborator INDUSTRY

  • Dana-Farber Cancer Institute

    collaborator OTHER

  • LifeWatch Services, Inc.

    collaborator INDUSTRY

  • Cavion, Inc.

    lead INDUSTRY

Principal Investigators

  • Scott Rasmussen, MD · Celerion

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-02-29
Primary Completion
2012-06-24
Completion
2012-06-24

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01550458 on ClinicalTrials.gov