drugset / Trial / NCT00606112

A Single Dose, Tolerance and Pharmacokinetic Study in Obese or Overweight Type 2 Diabetic Volunteers

NCT00606112 ↗

Phase 1 Completed 28 enrolled Genaera Corporation
RandomizedSingle-groupQuadruple-blindTreatment

Summary

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

Timeline

Start
2008-01
Primary completion
2008-06
Completion
2009-04

Drugs

EvaluationDrugModalityDoseRoute
Comparator Trodusquemine Small molecule 3 mg/m2 Intravenous
Comparator Trodusquemine Small molecule 6 mg/m2 Intravenous
Comparator Trodusquemine Small molecule 10 mg/m2 Intravenous
Comparator Trodusquemine Small molecule 15 mg/m2 Intravenous