NCT01550458

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

A Study of the Pharmacokinetic and Safety Profile of QID Dosing of Mibefradil in Normal Human Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Cavion, Inc. · Industry
• Sex: All
• Age: 19 Years – 55 Years
• Healthy volunteers: Accepted

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.

Detailed description

This study will establish the safety, detailed pharmacokinetics, and, possibly, maximum tolerated dose (MTD) of ascending doses of mibefradil administered four times a day (QID) in healthy volunteers. The knowledge gained will then guide the details of a study of Interlaced Therapy™ in patients with recurrent High Grade Glioma (HGG). Non-clinical studies are currently on-going in the efficacy of Interlaced Therapy™ in ovarian cancer, pancreatic cancer, and intracranial malignancy.

Conditions

• Healthy

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2012-02-01
• Primary completion: 2012-06-24
• Completion: 2012-06-24
• First posted: 2012-03-12
• Last updated: 2019-04-08

Locations

1 site across 1 country: United States