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

This study is currently recruiting participants.
Verified by Genaera Corporation, January 2008

Sponsored by: 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 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   

U.S. FDA Resources

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

Further study details as provided by Genaera Corporation:

Primary Outcome Measures:
  • Safety and Tolerance of a single intravenous dose of trodusquemine (MSI-1436) in obese, type 2 diabetics [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

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/
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/
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/
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/

  Eligibility
Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

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;
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00606112

Contacts
Contact: Wayne Yarnall     610-941-4020    

Locations
United States, Texas
dgd Research     Recruiting
      San Antonio, Texas, United States, 78229

Sponsors and Collaborators
Genaera Corporation

Investigators
Principal Investigator:     Mark Kipnes, MD     dgd Research    
  More Information


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

Study placed in the following topic categories:
Body Weight
Signs and Symptoms
Obesity
Metabolic Diseases
Diabetes Mellitus
Nutrition Disorders
Endocrine System Diseases
Overnutrition
Overweight
Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on November 06, 2008




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