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

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ClinicalTrials.gov Identifier: NCT00555451
Recruitment Status : Completed
First Posted : November 8, 2007
Last Update Posted : May 13, 2010
Sponsor:
Information provided by:
Harbor Therapeutics

Tracking Information
First Submitted Date  ICMJE November 6, 2007
First Posted Date  ICMJE November 8, 2007
Last Update Posted Date May 13, 2010
Study Start Date  ICMJE October 2007
Actual Primary Completion Date September 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 19, 2008)
safety and pharmacokinetics [ Time Frame: Duration of the study ]
Original Primary Outcome Measures  ICMJE
 (submitted: November 6, 2007)
Safety [ Time Frame: Duration of the study ]
Change History Complete list of historical versions of study NCT00555451 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 19, 2008)
To assess the potential activity of HE3286 to decrease insulin resistance [ Time Frame: duration of study ]
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety, Pharmacokinetics and Potential Activity of HE3286 in Obese Adult Subjects
Official Title  ICMJE 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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Insulin Resistance
Intervention  ICMJE 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)
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: May 19, 2008)
66
Original Estimated Enrollment  ICMJE
 (submitted: November 6, 2007)
54
Actual Study Completion Date  ICMJE September 2009
Actual Primary Completion Date September 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00555451
Other Study ID Numbers  ICMJE HE3286-0102
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Nanette Onizuka-Handa, Sr. Vice President, Regulatory Affairs and Quality, Hollis-Eden Pharmaceuticals
Study Sponsor  ICMJE Harbor Therapeutics
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Dwight R. Stickney, MD Harbor Therapeutics
PRS Account Harbor Therapeutics
Verification Date May 2010

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