drugset / Trial / NCT00606112
A Single Dose, Tolerance and Pharmacokinetic Study in Obese or Overweight Type 2 Diabetic Volunteers
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 |