Open-label Pharmacokinetic Study of Diazoxide Choline Coated vs. Uncoated Formulations

Essentialis

Status and phase: Completed; Phase 1

Conditions: Hypertriglyceridemia

Treatments: Drug: Diazoxide choline

Study type: Interventional

Funder types: NETWORK; Industry

Identifiers

NCT00688857

PK008

Details and patient eligibility

About

This is a single-center, randomized, open-label, multi-dose crossover study assessing the pharmacokinetic profiles of diazoxide choline coated versus uncoated formulations in healthy volunteers. The primary objective is to compare the pharmacokinetic (PK) profiles of diazoxide choline controlled-release coated tablets versus uncoated tablets in healthy volunteers under fed conditions. Secondary objectives are to assess diazoxide choline pharmacokinetic (PK) parameters under fasted conditions, and to assess the safety and tolerability of diazoxide choline controlled-release coated tablets versus uncoated tablets in healthy volunteers.

Enrollment: 12 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Signed informed consent
• Healthy male and female subjects 18 to 75 years of age
• Body mass index (BMI) between 22-35 kg/m2
• Fasting glucose ≤ 125 mg/dL and HbA1C ≤ 6.5.
• Fasting triglyceride ≥100 mg/dL and ≤ 500 mg/dL
• Not pregnant

Exclusion criteria

• Significant underlying medical conditions
• Clinical laboratory test values outside the accepted range
• Smokers, tobacco users, or subjects currently using nicotine products
• Substance abuse
• History of allergic response(s) to diazoxide or related drugs
• Recent significant weight loss
• Use of medication affecting body weight, lipid or glucose metabolism
• Unable to comply with study procedures

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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12 participants in 2 patient groups

A

Experimental group

Description:

Diazoxide choline controlled-release coated tablets administered orally once daily (Days 1 through 8). Diazoxide choline controlled-release uncoated tablets administered orally once daily (Days 9 through 16).

Treatment:

Drug: Diazoxide choline

Drug: Diazoxide choline

B

Experimental group

Description:

Diazoxide choline controlled-release uncoated tablets administered orally once daily (Days 1 through 8). Diazoxide choline controlled-release coated tablets administered orally once daily (Days 9 through 16)

Treatment:

Drug: Diazoxide choline

Drug: Diazoxide choline