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

• Status: Withdrawn
• Trial end date: 2011-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Essentialis, Inc.
• Treatments: Choline; Diazoxide

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