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

November 6, 2007
May 11, 2010
October 2007
September 2009   (final data collection date for primary outcome measure)
safety and pharmacokinetics [ Time Frame: Duration of the study ] [ Designated as safety issue: No ]
Safety [ Time Frame: Duration of the study ]
Complete list of historical versions of study NCT00555451 on ClinicalTrials.gov Archive Site
To assess the potential activity of HE3286 to decrease insulin resistance [ Time Frame: duration of study ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
Safety, Pharmacokinetics and Potential Activity of HE3286 in Obese Adult Subjects
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

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).

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.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Insulin Resistance
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)
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
66
September 2009
September 2009   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00555451
HE3286-0102
No
Nanette Onizuka-Handa, Sr. Vice President, Regulatory Affairs and Quality, Hollis-Eden Pharmaceuticals
Harbor Therapeutics
Not Provided
Study Director: Dwight R. Stickney, MD Harbor Therapeutics
Harbor Therapeutics
May 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP