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

This study has been completed.
Sponsor:
Information provided by:
Harbor Therapeutics
ClinicalTrials.gov Identifier:
NCT00555451
First received: November 6, 2007
Last updated: May 11, 2010
Last verified: May 2010
  Purpose

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 Intervention Phase
Insulin Resistance
Drug: HE3286
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Harbor Therapeutics:

Primary Outcome Measures:
  • safety and pharmacokinetics [ Time Frame: Duration of the study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To assess the potential activity of HE3286 to decrease insulin resistance [ Time Frame: duration of study ] [ Designated as safety issue: No ]

Estimated Enrollment: 66
Study Start Date: October 2007
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
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)
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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. 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: NCT00555451

Locations
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
Investigators
Study Director: Dwight R. Stickney, MD Harbor Therapeutics
  More Information

No publications provided

Responsible Party: Nanette Onizuka-Handa, Sr. Vice President, Regulatory Affairs and Quality, Hollis-Eden Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00555451     History of Changes
Other Study ID Numbers: HE3286-0102
Study First Received: November 6, 2007
Last Updated: May 11, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Harbor Therapeutics:
phase I
safety
tolerance
insulin resistance
obese
pharmacokinetics

Additional relevant MeSH terms:
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on September 18, 2014