NCT00806338

An Ascending Multi-Dose, Tolerance and Pharmacokinetic Study in Obese or Overweight Type 2 Diabetic Volunteers

A Phase I, Double-Blind, Randomized, Placebo-Controlled Ascending IV Multiple Dose Tolerance and Pharmacokinetic Study of Trodusquemine (MSI-1436) in Obese or Overweight Type 2 Diabetic Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Genaera Corporation · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the safety and tolerance of multiple intravenous (through a vein) doses of trodusquemine (MSI-1436) in obese or overweight, type 2 diabetics.

Detailed description

Different amounts of trodusquemine (MSI-1436) 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 (MSI-1436). Finally, this study will also determine whether trodusquemine (MSI-1436) 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

• Diabetes Mellitus
• Obesity

Interventions

Type	Name	Description
DRUG	Trodusquemine (MSI-1436)	A single dose of Trodusquemine (MSI-1436) will be administered every 72 hours on Days 0, 3, 6, 9, 12, 15, 18 and 21. Doses are 3mg/m2 in cohort 1, 6mg/m2 in cohort 2 and 10mg/m2 in cohort 3.
DRUG	Placebo

Timeline

• Start date: 2008-11-01
• Primary completion: 2009-04-01
• Completion: 2009-04-01
• First posted: 2008-12-10
• Last updated: 2009-04-15

Locations

2 sites across 1 country: United States