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

Genaera Corporation1 site in 1 country28 target enrollmentJanuary 2008

ConditionsDiabetes Mellitus Obesity

InterventionsTrodusquemine (MSI-1436)

DrugsTrodusquemine (MSI-1436)

Overview

Phase: Phase 1
Intervention: Trodusquemine (MSI-1436)
Conditions: Diabetes Mellitus
Sponsor: Genaera Corporation
Enrollment: 28
Locations: 1
Primary Endpoint: Safety and Tolerance of a single intravenous dose of trodusquemine (MSI-1436) in obese, type 2 diabetics
Status: Completed
Last Updated: 17 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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).

Registry

clinicaltrials.gov

Start Date

January 2008

End Date

April 2009

Last Updated

17 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Genaera Corporation

Eligibility Criteria

Inclusion Criteria

•male or female obese or overweight type 2 diabetic subjects, between 18 and 55 years old (inclusive)
•either treatment naive or who are inadequately controlled on either metformin alone or metformin in combination with a sulfonylurea. Subjects on metformin in combination with a sulfonylurea will be allowed a 2 week period to wash out the sulfonylurea before dosing.
•have a fasting blood sugar of ≥ 100 mg/dL, hemoglobin A1C ≥ 7.5% (but ≤ 11.0%). Subjects on a combination of metformin and sulfonylurea must have a hemoglobin A1C ≥ 7.5% (but ≤ 10.0%);
•body mass index (BMI) of 27-40 kg/m2

Exclusion Criteria

•likely allergy or sensitivity to any components of Trodusquemine (MSI-1436) for Injection based on known allergies to drugs of the same class;
•any subject with a history of allergy (rash, hives, breathing difficulty, etc.) to any medications, either prescription or nonprescription, including dietary supplements or herbal medications;
•any subject with a history of severe allergy or bronchial asthma;
•a clinically significant history of or current abnormality or disease of any organ system, including renal, hepatic, gastrointestinal, cardiovascular (except hyperlipidemia or controlled hypertension), pulmonary (including chronic asthma), endocrine (except diabetes), central nervous, or hematologic systems, or recent clinically significant surgery;