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

Essentialis

Status and phase: Withdrawn; Phase 1

Conditions: Hypertriglyceridemia

Treatments: Drug: Diazoxide choline high dose; Drug: Diazoxide choline

Study type: Interventional

Funder types: Industry

Identifiers

NCT00901823

PK010

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Sequence 1

Experimental group

Description:

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

Treatment:

Drug: Diazoxide choline

Sequence 2

Experimental group

Description:

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

Treatment:

Drug: Diazoxide choline high dose