Open-Label, Single- and Multiple-Dose Pharmacokinetic Study of Diazoxide Choline

Sponsor

Essentialis, Inc. (Industry)

Overall Status

Withdrawn

CT.gov ID

NCT00901823

Collaborator

(none)

Enrollment

Arms

Study Details

Study Description

Brief Summary

This is a single-center, randomized, open-label, single- and multiple-dose, five-treatment, two-period, four-way parallel study comparing the pharmacokinetics (PK) of Diazoxide Choline Controlled-Release Tablet (DCCR) administered orally under fed and fasting conditions at two dose levels.

Condition or Disease	Intervention/Treatment	Phase
Hypertriglyceridemia	Drug: Diazoxide choline Drug: Diazoxide choline high dose	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Randomized, Open-Label, Single- and Multiple-Dose, Four-Way Parallel Study Comparing the Fed and Fasted Pharmacokinetics of Two Dose Levels of Diazoxide Choline Controlled-Release Tablet (DCCR) in Healthy VolunteersVOLUNTEERS

Study Start Date :

Mar 1, 2011

Anticipated Primary Completion Date :

Mar 1, 2011

Anticipated Study Completion Date :

Mar 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Sequence 1 Single dose of low dose DCCR followed by a 14 day washout, then re-randomized to either low or high multiple dose DCCR	Drug: Diazoxide choline A single dose low dose DCCR then re-randomized to either multiple dose low dose DCCR or high dose DCCR
Experimental: Sequence 2 Single dose of high dose DCCR followed by a 14 day washout, then re-randomized to either low or high multiple dose DCCR	Drug: Diazoxide choline high dose A single dose high dose DCCR then re-randomized to either low or high multiple doses of DCCR

Arm

Intervention/Treatment

Experimental: Sequence 1

Single dose of low dose DCCR followed by a 14 day washout, then re-randomized to either low or high multiple dose DCCR

Drug: Diazoxide choline

A single dose low dose DCCR then re-randomized to either multiple dose low dose DCCR or high dose DCCR

Experimental: Sequence 2

Single dose of high dose DCCR followed by a 14 day washout, then re-randomized to either low or high multiple dose DCCR

Drug: Diazoxide choline high dose

A single dose high dose DCCR then re-randomized to either low or high multiple doses of DCCR

Outcome Measures

Primary Outcome Measures

Compare the single-dose and steady-state, fed and fasting PK profiles of two dose levels of diazoxide administered as DCCR [35 days]

Secondary Outcome Measures

Assess the impact of dosing in the absence of food on the steady-state pharmacokinetic profiles of two dose levels of diazoxide administered orally as DCCR under fed conditions [35 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Signed informed consent
Healthy adults
Fasting glucose ≤ 125 mg/dL and HbA1C ≤ 6.5
Fasting triglyceride ≥150 mg/dL and ≤ 500 mg/dL

Exclusion Criteria:

Known CAD, DM, uncontrolled HTN
Pregnancy or unable to complaint with the birth control method required

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Essentialis, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT00901823

Other Study ID Numbers:

PK010

First Posted:

May 14, 2009

Last Update Posted:

Sep 1, 2016

Last Verified:

Aug 1, 2016

Additional relevant MeSH terms:

Hypertriglyceridemia

Diazoxide

Choline

Study Results

No Results Posted as of Sep 1, 2016