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

Obesity Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00606112
• Other study ID #: MSI-1436C-103
• Status: Completed
• Phase: Phase 1
• First received: January 21, 2008
• Last updated: April 14, 2009
• Start date: January 2008
• Est. completion date: April 2009

Study information

• Verified date: April 2009
• Source: Genaera Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: April 2009
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

1. male or female obese or overweight type 2 diabetic subjects, between 18 and 55 years old (inclusive)

2. 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.

3. 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%);

4. non-smoker

5. body mass index (BMI) of 27-40 kg/m2

Exclusion Criteria:

1. likely allergy or sensitivity to any components of Trodusquemine (MSI-1436) for Injection based on known allergies to drugs of the same class;

2. 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;

3. any subject with a history of severe allergy or bronchial asthma;

4. 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;

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Obesity

Intervention

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/

Locations

Country	Name	City	State
United States	dgd Research	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Genaera Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and Tolerance of a single intravenous dose of trodusquemine (MSI-1436) in obese, type 2 diabetics		6 months	Yes