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| Sponsor: | Genaera Corporation |
|---|---|
| Information provided by: | Genaera Corporation |
| ClinicalTrials.gov Identifier: | NCT00606112 |
Purpose
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).
| Condition | Intervention | Phase |
|---|---|---|
|
Diabetes Mellitus Obesity |
Drug: Trodusquemine (MSI-1436) |
Phase I |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Phase I, Double-Blind, Randomized, Placebo-Controlled Ascending IV Single-Dose Tolerance and Pharmacokinetic Study of Trodusquemine (MSI-1436) in Obese Type 2 Diabetics |
| Enrollment: | 28 |
| Study Start Date: | January 2008 |
| Study Completion Date: | April 2009 |
| Primary Completion Date: | June 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Placebo Comparator: 1 |
Drug: Trodusquemine (MSI-1436)
A single dose will be administered on Day 0. Doses are 3mg/m2 in cohort 1, 6mg/m2 in cohort 2, 10mg/m2 in cohort 3 and 15mg/m2 in cohort 4/
|
| Placebo Comparator: 2 |
Drug: Trodusquemine (MSI-1436)
A single dose will be administered on Day 0. Doses are 3mg/m2 in cohort 1, 6mg/m2 in cohort 2, 10mg/m2 in cohort 3 and 15mg/m2 in cohort 4/
|
| Placebo Comparator: 3 |
Drug: Trodusquemine (MSI-1436)
A single dose will be administered on Day 0. Doses are 3mg/m2 in cohort 1, 6mg/m2 in cohort 2, 10mg/m2 in cohort 3 and 15mg/m2 in cohort 4/
|
| Placebo Comparator: 4 |
Drug: Trodusquemine (MSI-1436)
A single dose will be administered on Day 0. Doses are 3mg/m2 in cohort 1, 6mg/m2 in cohort 2, 10mg/m2 in cohort 3 and 15mg/m2 in cohort 4/
|
Eligibility| Ages Eligible for Study: | 18 Years to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Texas | |
| dgd Research | |
| San Antonio, Texas, United States, 78229 | |
| Principal Investigator: | Mark Kipnes, MD | dgd Research |
| Principal Investigator: | Gilbert R. Weiner, D.O. AOBFP | Allied Research International |
More Information
| Responsible Party: | Michael Gast, MD, PhD, Genaera Corporation |
| ClinicalTrials.gov Identifier: | NCT00606112 History of Changes |
| Other Study ID Numbers: | MSI-1436C-103 |
| Study First Received: | January 21, 2008 |
| Last Updated: | April 14, 2009 |
| Health Authority: | United States: Food and Drug Administration |
|
Diabetes Mellitus Obesity Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |
Overnutrition Nutrition Disorders Overweight Body Weight Signs and Symptoms |