A Study of the Safety, Tolerance and Assessment of HE3286 on Insulin Sensitivity and Hepatic Glucose Production
A Phase I, Open Label Study of the Safety, Tolerance and Assessment of HE3286 on Insulin Sensitivity and Hepatic Glucose Production When Administered Orally to Obese Insulin-Resistant Adult Subjects for 28 Days
1 other identifier
interventional
5
1 country
1
Brief Summary
The objectives of this study are to evaluate the safety and tolerance of 20 mg (10 mg BID) of HE3286 when administered orally over 28 days to obese insulin-resistant adult subjects and, to assess the activity of HE3286 on insulin sensitivity and hepatic glucose production in obese insulin-resistant adult subjects.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Sep 2009
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2009
CompletedFirst Submitted
Initial submission to the registry
October 5, 2009
CompletedFirst Posted
Study publicly available on registry
October 7, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2010
CompletedMarch 9, 2011
March 1, 2011
11 months
October 5, 2009
March 8, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Safety and tolerance of 20 mg (10 mg BID) of HE3286 when administered orally over 28 days to obese insulin-resistant adult subjects
Study duration and 1-month follow-up
Secondary Outcomes (1)
Activity of HE3286 on insulin sensitivity and hepatic glucose production in obese insulin-resistant adult subjects.
Study period (28-days)
Study Arms (1)
HE3286
EXPERIMENTALHE3286 20 mg (10 mg BID)
Interventions
Eligibility Criteria
You may qualify if:
- Male or female subject 18-65 years of age
- Body Mass Index (BMI) is at least 29 kg/m2 but no more than 35 kg/m2 for females and no more than 37 kg/m2 for males
- Subject has fasting blood glucose level of \< 126 mg/dL at Screening
- Subject has a 2 hour postprandial (following 75 grams glucose administration) blood glucose of 140-200 mg/dL at Screening
- Subject has fasting plasma insulin \>=10 μU/mL
You may not qualify if:
- Subject has a history of clinically significant cardiovascular disease (including coronary artery disease), clinically significant hepatic, respiratory or renal abnormalities, clinically significant endocrine disorders (including history of diabetes); or clinically significant neurological or psychiatric condition;
- Subject has any clinically significant abnormalities in laboratory results at screening
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Clinical Site
Baton Rouge, Louisiana, 70808, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Dwight R. Stickney, MD
Harbor Therapeutics
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
October 5, 2009
First Posted
October 7, 2009
Study Start
September 1, 2009
Primary Completion
August 1, 2010
Study Completion
August 1, 2010
Last Updated
March 9, 2011
Record last verified: 2011-03