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Trials / Completed

CompletedNCT00509132

A Tolerance and Pharmacokinetic Study of Trodusquemine in Healthy Volunteers

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

Status
Completed
Phase
Phase 1
Study type
Interventional
Enrollment
42 (estimated)
Sponsor
Genaera Corporation · Industry
Sex
All
Age
18 Years – 55 Years
Healthy volunteers
Accepted

Summary

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).

Conditions

Interventions

TypeNameDescription
DRUGtrodusquemine

Timeline

Start date
2007-05-01
Primary completion
2007-10-01
Completion
2007-10-01
First posted
2007-07-31
Last updated
2008-01-09

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT00509132. Inclusion in this directory is not an endorsement.

A Tolerance and Pharmacokinetic Study of Trodusquemine in Healthy Volunteers (NCT00509132) · Clinical Trials Directory