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

Sponsor

Harbor Therapeutics (Industry)

Overall Status

Completed

CT.gov ID

NCT00555451

Collaborator

(none)

Enrollment

Locations

Duration (Months)

Patients Per Site

1.4

Patients Per Site Per Month

Study Details

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).

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.

Study Design

Study Type:

Interventional

Anticipated 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 :

Oct 1, 2007

Actual Primary Completion Date :

Sep 1, 2009

Actual Study Completion Date :

Sep 1, 2009

Outcome Measures

Primary Outcome Measures

safety and pharmacokinetics [Duration of the study]

Secondary Outcome Measures

To assess the potential activity of HE3286 to decrease insulin resistance [duration of study]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

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