Back to resultsSafety, Pharmacokinetics and Potential Activity of HE3286 in Obese Adult Subjects
Primary Purpose
Insulin Resistance
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
HE3286
Sponsored by
About this trial
This is an interventional treatment trial for Insulin Resistance focused on measuring phase I, safety, tolerance, insulin resistance, obese, pharmacokinetics
Eligibility Criteria
Main Inclusion Criteria:
- Males or females between 18 and 65 years of age
- Body mass index for females between 29 and 35 kg/m2 and no more than 37 kgm2 for males
- Fasting blood glucose level < 126 mg/dL at screening
- 2 hour postprandial (following 75 grams glucose) blood glucose between 140 to 200 mg/dL
- Normal thyroid stimulating hormone with or without thyroid replacement therapy
- Fasting triglycerides < 350 mg/dL
- For females of reproductive potential, agree to avoid pregnancy during the study and for 3 months following study completion, have a negative serum and/or urine pregnancy test, and use an acceptable method of birth control
- Non-smoker or has not smoked for 6 months prior to the screening visit
- No history of alcohol abuse within 2 years
- Negative drug screen at screening and baseline
- Stable weight (+/- 5%); no history of weight loss or gain (> 10% body weight)
- Must provide voluntary, written, informed consent prior to screening evaluations
- Must be able to swallow capsules
Main Exclusion Criteria:
- Marked prolongation of QT/QTc interval or history of additional risk factors for Torsades de Pointes at screening or baseline
- Positive for HIV, HAV, HBV or HCV
- History of clinically significant cardiovascular, hepatic, respiratory or renal or endocrine disorders
- History of breast and/or prostate cancer
- Clinically significant neurological or psychiatric condition, uncontrolled hypertension, clinically significant unstable medical abnormality, chronic disease or active, serious clinical infection or condition
- Personal or family member with breast and/or prostate cancer
- Malignancy within past 5 years except for successfully treated basal cell carcinoma of the skin
- Personal and/or family history of venous thromboembolism
- History of stroke and/or heart attack
- Medication prohibited from study
Sites / Locations
- dgd Research, Inc.
Outcomes
Primary Outcome Measures
safety and pharmacokinetics
Secondary Outcome Measures
To assess the potential activity of HE3286 to decrease insulin resistance
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00555451
Brief Title
Safety, Pharmacokinetics and Potential Activity of HE3286 in Obese Adult Subjects
Official Title
A Phase I, Double-Blind, Placebo-Controlled, Dose Ranging Study of the Safety, Tolerance, Pharmacokinetics and Potential Activity of HE3286 When Administered Orally to Obese Adult Subjects for 28 Days
Study Type
Interventional
2. Study Status
Record Verification Date
May 2010
Overall Recruitment Status
Completed
Study Start Date
October 2007 (undefined)
Primary Completion Date
September 2009 (Actual)
Study Completion Date
September 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Harbor Therapeutics
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The objectives of this study are to evaluate the safety, tolerance and pharmacokinetics of HE3286 when administered daily for 28 days to obese adult subjects and to assess potential activity of HE3286 to decrease insulin resistance. An open-label cohort of 6 patients with type II diabetes mellitus will be treated at 10 mg (5 mg BID).
Detailed Description
HE3286 has a potentially new mechanism of action that may improve the current therapeutic options available to patients with metabolic disorders, inflammatory and autoimmune diseases. In preclinical experiments, HE3286 has shown to have anti-inflammatory activity associated with corticosteroids but without the side effects known with corticosteroid use, such as immune suppression and bone loss. HE3286 has demonstrated glucose-lowering and insulin-enhancing effects in several preclinical mouse and rat models of insulin resistance. In these experiments, HE3286 lowered blood glucose levels and prevented progression of hyperglycemia and HE3286 appeared to enhance insulin sensitivity.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insulin Resistance
Keywords
phase I, safety, tolerance, insulin resistance, obese, pharmacokinetics
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
66 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
HE3286
Intervention Description
Dose escalating cohort driven study. 6 planned cohorts.
HE3286 5 mg or placebo QD for 28 days;
HE3286 10 mg (5 mg BID) or placebo BID for 28 days
HE3286 20 mg (10 mg BID) or placebo BID for 28 days
HE3286 40 mg (20 mg BID) or placebo BID for 28 days
HE3286 4 mg (2 mg BID), 20 mg (10 mg BID) or placebo BID for 28 days
HE3286 10mg (5 mg BID) for 28 days (open-label cohort in patients with T2DM)
Primary Outcome Measure Information:
Title
safety and pharmacokinetics
Time Frame
Duration of the study
Secondary Outcome Measure Information:
Title
To assess the potential activity of HE3286 to decrease insulin resistance
Time Frame
duration of study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Main Inclusion Criteria:
Males or females between 18 and 65 years of age
Body mass index for females between 29 and 35 kg/m2 and no more than 37 kgm2 for males
Fasting blood glucose level < 126 mg/dL at screening
2 hour postprandial (following 75 grams glucose) blood glucose between 140 to 200 mg/dL
Normal thyroid stimulating hormone with or without thyroid replacement therapy
Fasting triglycerides < 350 mg/dL
For females of reproductive potential, agree to avoid pregnancy during the study and for 3 months following study completion, have a negative serum and/or urine pregnancy test, and use an acceptable method of birth control
Non-smoker or has not smoked for 6 months prior to the screening visit
No history of alcohol abuse within 2 years
Negative drug screen at screening and baseline
Stable weight (+/- 5%); no history of weight loss or gain (> 10% body weight)
Must provide voluntary, written, informed consent prior to screening evaluations
Must be able to swallow capsules
Main Exclusion Criteria:
Marked prolongation of QT/QTc interval or history of additional risk factors for Torsades de Pointes at screening or baseline
Positive for HIV, HAV, HBV or HCV
History of clinically significant cardiovascular, hepatic, respiratory or renal or endocrine disorders
History of breast and/or prostate cancer
Clinically significant neurological or psychiatric condition, uncontrolled hypertension, clinically significant unstable medical abnormality, chronic disease or active, serious clinical infection or condition
Personal or family member with breast and/or prostate cancer
Malignancy within past 5 years except for successfully treated basal cell carcinoma of the skin
Personal and/or family history of venous thromboembolism
History of stroke and/or heart attack
Medication prohibited from study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dwight R. Stickney, MD
Organizational Affiliation
Harbor Therapeutics
Official's Role
Study Director
Facility Information:
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70808
Country
United States
Facility Name
dgd Research, Inc.
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
12. IPD Sharing Statement
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Safety, Pharmacokinetics and Potential Activity of HE3286 in Obese Adult Subjects
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