A Single Dose, Tolerance and Pharmacokinetic Study in Obese or Overweight Type 2 Diabetic Volunteers
This study has been completed.
Sponsor:
Genaera Corporation
Information provided by:
Genaera Corporation
ClinicalTrials.gov Identifier:
NCT00606112
First received: January 21, 2008
Last updated: April 14, 2009
Last verified: April 2009
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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 1 |
| 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 |
Resource links provided by NLM:
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 ]
| 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 |
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%);
- non-smoker
- 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;
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00606112
Locations
| United States, Texas | |
| dgd Research | |
| San Antonio, Texas, United States, 78229 | |
Sponsors and Collaborators
Genaera Corporation
Investigators
| Principal Investigator: | Mark Kipnes, MD | dgd Research |
| Principal Investigator: | Gilbert R. Weiner, D.O. AOBFP | Allied Research International |
More Information
No publications provided
| 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 |
Additional relevant MeSH terms:
|
Diabetes Mellitus Obesity Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |
Overnutrition Nutrition Disorders Overweight Body Weight Signs and Symptoms |
ClinicalTrials.gov processed this record on June 17, 2013