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Sponsored by: |
Genaera Corporation |
Information provided by: | Genaera Corporation |
ClinicalTrials.gov Identifier: | NCT00606112 |
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 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).
Condition | Intervention | Phase |
Diabetes Mellitus Obesity |
Drug: Trodusquemine (MSI-1436) |
Phase I |
MedlinePlus related topics: | Diabetes Obesity |
Drug Information available for: | Trodusquemine |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Single Group Assignment, Safety Study |
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 |
Estimated Enrollment: | 28 |
Study Start Date: | January 2008 |
Estimated Primary Completion Date: | June 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
1: Placebo Comparator |
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/
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2: Placebo Comparator |
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/
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3: Placebo Comparator |
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/
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4: Placebo Comparator |
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/
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Ages Eligible for Study: | 18 Years to 55 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Wayne Yarnall | 610-941-4020 |
United States, Texas | |||||
dgd Research | Recruiting | ||||
San Antonio, Texas, United States, 78229 |
Genaera Corporation |
Principal Investigator: | Mark Kipnes, MD | dgd Research |
Responsible Party: | Genaera Corporation ( Michael Gast, MD, PhD ) |
Study ID Numbers: | MSI-1436C-103 |
First Received: | January 21, 2008 |
Last Updated: | January 31, 2008 |
ClinicalTrials.gov Identifier: | NCT00606112 |
Health Authority: | United States: Food and Drug Administration |
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