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

NCT00555451 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2010-05-13

No results posted yet for this study

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

Interventions

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)

Sponsors & Collaborators

  • Harbor Therapeutics

    lead INDUSTRY

Principal Investigators

  • Dwight R. Stickney, MD · Harbor Therapeutics

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-10-31
Primary Completion
2009-09-30
Completion
2009-09-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00555451 on ClinicalTrials.gov