A Tolerance and Pharmacokinetic Study of Trodusquemine in Healthy Volunteers

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).

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Quintiles, Inc.

Overland Park, Kansas, 66283, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

trodusquemine

Drug

Sponsors and collaborators

Lead sponsor

Genaera Corporation

Industry

Registry information

Official study title

A Phase I, Double-Blind, Randomized, Placebo-Controlled Ascending IV Single-Dose Tolerance and Pharmacokinetic Study of Trodusquemine in Healthy Volunteers

Important dates

Study start: 2007
Primary completion: 2007
Study completion: 2007
First posted: Jul 31, 2007
Registry last updated: Jan 9, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed