Ignite Creation Date:
2025-12-25 @ 2:08 AM
Ignite Modification Date:
2025-12-28 @ 12:01 AM
Study NCT ID:
NCT01211860
Status:
COMPLETED
Last Update Posted:
2014-01-10
First Post:
2010-09-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pharmacokinetic Study of Diazoxide Choline in Hypertriglyeridemic Subjects
Sponsor:
Essentialis, Inc.
Organization:
Study Overview
Official Title:
A Multiple-Dose Pharmacokinetic Study of Diazoxide Choline Controlled-Release Tablet (DCCR) in Subjects With Elevated Fasting Triglyceride Levels
Status:
COMPLETED
Status Verified Date:
2014-01
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:
Once a day oral administration with DCCR is the optimal dosing regimen
Detailed Description:
POPULATION The population will consist of generally healthy subjects with elevated fasting triglyceride levels in the range of ≥ 150 mg/dL and ≤ 1500 mg/dL at the Screening Visit.
Number of Subjects A total of 10 subjects will be enrolled in the study at 1 site in the USA.
Number of Subjects A total of 10 subjects will be enrolled in the study at 1 site in the USA.
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?: