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

NCT ID: NCT00901823

Last Updated: 2016-09-01

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE1
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-03-31
• Study Completion Date: 2011-03-31

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.

Conditions

Hypertriglyceridemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Diazoxide choline

Intervention Type: DRUG

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

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

Group Type: EXPERIMENTAL

Diazoxide choline high dose

Intervention Type: DRUG

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

Interventions

Diazoxide choline

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

Intervention Type: DRUG

Diazoxide choline high dose

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

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Essentialis, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Essentialis Inc.

Other Identifiers

PK010

Identifier Type: -

Identifier Source: org_study_id