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Safety, Pharmacokinetics and Potential Activity of HE3286 in Obese Adult Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00555451
Recruitment Status : Completed
First Posted : November 8, 2007
Last Update Posted : May 13, 2010
Information provided by:
Harbor Therapeutics

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).

Condition or disease Intervention/treatment Phase
Insulin Resistance Drug: HE3286 Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : October 2007
Actual Primary Completion Date : September 2009
Actual Study Completion Date : September 2009

Intervention Details:
  • Drug: HE3286

    Dose escalating cohort driven study. 6 planned cohorts.

    1. HE3286 5 mg or placebo QD for 28 days;
    2. HE3286 10 mg (5 mg BID) or placebo BID for 28 days
    3. HE3286 20 mg (10 mg BID) or placebo BID for 28 days
    4. HE3286 40 mg (20 mg BID) or placebo BID for 28 days
    5. HE3286 4 mg (2 mg BID), 20 mg (10 mg BID) or placebo BID for 28 days
    6. HE3286 10mg (5 mg BID) for 28 days (open-label cohort in patients with T2DM)

Primary Outcome Measures :
  1. safety and pharmacokinetics [ Time Frame: Duration of the study ]

Secondary Outcome Measures :
  1. To assess the potential activity of HE3286 to decrease insulin resistance [ Time Frame: duration of study ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00555451

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United States, Louisiana
Baton Rouge, Louisiana, United States, 70808
United States, Texas
dgd Research, Inc.
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Harbor Therapeutics
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Study Director: Dwight R. Stickney, MD Harbor Therapeutics

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Responsible Party: Nanette Onizuka-Handa, Sr. Vice President, Regulatory Affairs and Quality, Hollis-Eden Pharmaceuticals Identifier: NCT00555451     History of Changes
Other Study ID Numbers: HE3286-0102
First Posted: November 8, 2007    Key Record Dates
Last Update Posted: May 13, 2010
Last Verified: May 2010
Keywords provided by Harbor Therapeutics:
phase I
insulin resistance
Additional relevant MeSH terms:
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Insulin Resistance
Glucose Metabolism Disorders
Metabolic Diseases
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs