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NCT00555451 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study of Insulin Resistance, sponsored by Harbor Therapeutics.

Completed
Registry status
Phase 1
Development phase
66
Enrollment target
2
Study locations

NCT00555451 is a Phase 1 study of Insulin Resistance that has completed, run by Harbor Therapeutics. The registered enrollment target is 66 participants, below the 245-participant average among 120 other Insulin Resistance trials with a reported enrollment target (73% lower). The trial reports 2 study locations across 2 states.

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The verdict

NCT00555451, a Phase 1 study of Insulin Resistance, has completed, sponsored by Harbor Therapeutics.

COMPLETED
Registry status
Phase 1
Development phase
66 participants
Enrollment target
2
Study locations

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 Studied

Insulin Resistance

Interventions

  • DRUG HE3286

Study Locations (2)

Louisiana

  • - Baton Rouge

Texas

  • dgd Research, Inc. - San Antonio

Trial Details

FieldValue
Enrollment Target 66 participants
Start Date 2007-10
Est. Completion 2009-09
Phase Phase 1

Sponsor

Harbor Therapeutics

7 total trials

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What the Registry Record Tells You About NCT00555451

The ClinicalTrials.gov registry entry for NCT00555451 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 66 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 245-participant average among 120 other Insulin Resistance trials with a reported enrollment target (73% lower). The listed sponsor is Harbor Therapeutics, which has 7 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Insulin Resistance appearing as the primary indexed condition, and to 1 intervention - of which HE3286 is the first listed.

NCT00555451 reports 2 study locations spanning 2 distinct geographic areas - top geographies include Louisiana, Texas.

Frequently Asked Questions

What is clinical trial NCT00555451 about?

NCT00555451 is a clinical study titled "Safety, Pharmacokinetics and Potential Activity of HE3286 in Obese Adult Subjects". 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 w...

What is the current status of trial NCT00555451?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 66 participants. The study started on 2007-10. Estimated completion is 2009-09.

What conditions does trial NCT00555451 study?

This clinical trial studies the following conditions: Insulin Resistance.

What interventions are being tested in trial NCT00555451?

The interventions under investigation include: HE3286 (DRUG).

Who is sponsoring clinical trial NCT00555451?

This trial is sponsored by Harbor Therapeutics, which has 7 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00555451 being conducted?

This trial has 2 study locations across Louisiana, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.