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A Tolerance and Pharmacokinetic Study of Trodusquemine in Healthy Volunteers

This study has been completed.
Sponsor:
Information provided by:
Genaera Corporation
ClinicalTrials.gov Identifier:
NCT00509132
First received: July 27, 2007
Last updated: January 8, 2008
Last verified: January 2008
History of Changes
  Purpose

The purpose of this study is to evaluate the safety and tolerance of single intravenous (through a vein) doses of trodusquemine. Different amounts of trodusquemine will be given to each volunteer group throughout the study. Another purpose is to evaluate the pharmacokinetics (PK - the study of the way the drug enters and leaves the blood and tissues over time) of trodusquemine. Finally, this study will also determine whether trodusquemine has any effect on appetite, mood or behavior, and selective biomarkers (substances in your blood that may change in response to the study drug).


Condition Intervention Phase
Obesity
 Drug: trodusquemine
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase I, Double-Blind, Randomized, Placebo-Controlled Ascending IV Single-Dose Tolerance and Pharmacokinetic Study of Trodusquemine in Healthy Volunteers

Resource links provided by NLM:

MedlinePlus related topics: Obesity
U.S. FDA Resources

Further study details as provided by Genaera Corporation:

Estimated Enrollment: 42
Study Start Date: May 2007
Study Completion Date: October 2007
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • male or female subjects, between 18 and 55 years old (inclusive);
  • body mass index (BMI) of 27-40 kg/m2;

Exclusion Criteria:

  • likely allergy or sensitivity to any components of Trodusquemine for Injection based on known allergies to drugs of the same class, or which, in the opinion of the Principal Investigator, suggests an increased potential for an adverse hypersensitivity to trodusquemine HCl;
  • any subject with a history of allergy (rash, hives, breathing difficulty, etc.) to any medications, either prescription or nonprescription, including dietary supplements or herbal medications;
  • any subject with a history of severe allergy or bronchial asthma;
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00509132

Locations
United States, Kansas
Quintiles, Inc.
Overland Park, Kansas, United States, 66283
Sponsors and Collaborators
Genaera Corporation
Investigators
Principal Investigator: Phil Leese, MD Quintiles
  More Information

No publications provided

Responsible Party: Michael Gast, MD, PhD, Genaera Corporation
ClinicalTrials.gov Identifier: NCT00509132     History of Changes
Other Study ID Numbers: MSI-1436C-101
Study First Received: July 27, 2007
Last Updated: January 8, 2008
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
 Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on June 18, 2013