Ignite Creation Date:
2025-12-25 @ 12:01 AM
Ignite Modification Date:
2025-12-25 @ 9:59 PM
Study NCT ID:
NCT01550458
Status:
COMPLETED
Last Update Posted:
2019-04-08
First Post:
2012-02-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Safety Study of Mibefradil When Given Four Times a Day in Healthy Volunteers
Sponsor:
Cavion, Inc.
Organization:
Study Overview
Official Title:
A Study of the Pharmacokinetic and Safety Profile of QID Dosing of Mibefradil in Normal Human Volunteers
Status:
COMPLETED
Status Verified Date:
2018-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: