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

NCT00555451 | Completed Phase 1

• 1 other identifier: HE3286-0102
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 2

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).

Conditions

Insulin Resistance

Keywords

phase I; safety; tolerance; insulin resistance; obese; pharmacokinetics

Outcome Measures

Primary Outcomes (1)

• safety and pharmacokinetics

  Duration of the study

Secondary Outcomes (1)

• To assess the potential activity of HE3286 to decrease insulin resistance

  duration of study

Interventions

HE3286 DRUG

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)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Harbor Therapeutics: lead

Study Sites (2)

Unknown Facility

Baton Rouge, Louisiana, 70808, United States

Location

dgd Research, Inc.

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Insulin Resistance; Obesity

Interventions

17-ethynyl-5-androstene-3, 7, 17-triol

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Dwight R. Stickney, MD

  Harbor Therapeutics

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 6, 2007
• First Posted: November 8, 2007
• Study Start: October 1, 2007
• Primary Completion: September 1, 2009
• Study Completion: September 1, 2009
• Last Updated: May 13, 2010

Record last verified: 2010-05

Locations

US (2)