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A Tolerance and Pharmacokinetic Study of Trodusquemine in Healthy Volunteers

This study has been completed.
Information provided by:
Genaera Corporation Identifier:
First received: July 27, 2007
Last updated: January 8, 2008
Last verified: January 2008
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
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, 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

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)

Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00509132

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

Responsible Party: Michael Gast, MD, PhD, Genaera Corporation Identifier: NCT00509132     History of Changes
Other Study ID Numbers: MSI-1436C-101
Study First Received: July 27, 2007
Last Updated: January 8, 2008 processed this record on August 18, 2017