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Open-label Pharmacokinetic Study of Diazoxide Choline Coated vs. Uncoated Formulations
This study has been completed.
Sponsor:
Essentialis, Inc.
Collaborator:
Cetero Research, San Antonio
Information provided by:
Essentialis, Inc.
ClinicalTrials.gov Identifier:
NCT00688857
First received: May 28, 2008
Last updated: November 4, 2010
Last verified: November 2010
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
| Hypertriglyceridemia | Drug: Diazoxide choline | Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Crossover Assignment Masking: None (Open Label) Primary Purpose: Treatment |
| Official Title: | A Randomized, Open-label, Multi-dose Crossover Study Assessing the Pharmacokinetic Profiles of Diazoxide Choline Coated Versus Uncoated Formulations in Healthy Volunteers |
Resource links provided by NLM:
Further study details as provided by Essentialis, Inc.:
Primary Outcome Measures:
- Compare the pharmacokinetic (PK) profiles of diazoxide choline controlled-release coated tablets versus uncoated tablets in healthy volunteers under fed conditions. [ Time Frame: 16 days ]
Secondary Outcome Measures:
- Assess diazoxide choline pharmacokinetic (PK) parameters under fasted conditions [ Time Frame: Study days 8 and 16 ]
- Assess the safety and tolerability of diazoxide choline controlled-release coated tablets versus uncoated tablets in healthy volunteers. [ Time Frame: Entire study ]
| Estimated Enrollment: | 12 |
| Study Start Date: | May 2008 |
| Study Completion Date: | July 2008 |
| Primary Completion Date: | June 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: A
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).
|
Drug: Diazoxide choline
Diazoxide choline controlled-release coated tablets versus Diazoxide choline controlled-release uncoated tablets administered orally once daily
|
|
Experimental: B
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)
|
Drug: Diazoxide choline
Diazoxide choline controlled-release uncoated tablets versus Diazoxide choline controlled-release coated tablets administered orally once daily
|
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
Criteria
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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00688857
Please refer to this study by its ClinicalTrials.gov identifier: NCT00688857
Locations
| United States, North Dakota | |
| PRACS Institute, Ltd. - Cetero Research | |
| Fargo, North Dakota, United States, 58104 | |
Sponsors and Collaborators
Essentialis, Inc.
Cetero Research, San Antonio
Investigators
| Principal Investigator: | Alan K. Copa, Pharm. D. | PRACS Institute, Ltd. - Cetero Research |
More Information
| Responsible Party: | Neil M Cowen, PhD/Chief Scientific Officer, Essentialis, Inc |
| ClinicalTrials.gov Identifier: | NCT00688857 History of Changes |
| Other Study ID Numbers: |
PK008 |
| Study First Received: | May 28, 2008 |
| Last Updated: | November 4, 2010 |
Additional relevant MeSH terms:
|
Hypertriglyceridemia Hyperlipidemias Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases Choline Diazoxide Lipotropic Agents |
Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Gastrointestinal Agents Lipid Regulating Agents Nootropic Agents Antihypertensive Agents Vasodilator Agents |
ClinicalTrials.gov processed this record on September 21, 2017