Overview

An Ascending Multi-Dose, Tolerance and Pharmacokinetic Study in Obese or Overweight Type 2 Diabetic Volunteers

Status:
Completed
Trial end date:
2009-04-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to evaluate the safety and tolerance of multiple intravenous (through a vein) doses of trodusquemine (MSI-1436) in obese or overweight, type 2 diabetics.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Genaera Corporation
Criteria
Inclusion Criteria:

1. male or female obese or overweight type 2 diabetic subjects, between 18 and 65 years
old (inclusive) either treatment naïve or who are inadequately controlled on metformin
alone;

2. subjects receiving metformin should be on stable dose for at least two weeks prior to
enrollment;

3. have a fasting blood sugar of ≥ 100 mg/dL and hemoglobin A1C ≥ 7.5% (but ≤ 11.0%) at
study entry;

4. of any race who are in good health (based on medical history, physical examination,
electrocardiograms [ECGs], and clinical laboratory tests);

5. non-smokers (refrained from any tobacco or nicotine usage, including smokeless
tobacco, nicotine patches, etc.,) for 6 months prior to Day 0 of the study. Subjects
must have cotinine levels below those measured for smokers based on reference lab
values;

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

7. able to execute informed written consent;

8. willingness to remain in the clinic for the inpatient portion of the study and return
for follow-up visits as required by the protocol and as deemed necessary by the
Principal Investigator;

Exclusion Criteria:

1. likely allergy or sensitivity to any components of Trodusquemine (MSI-1436C) for
Injection;

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

3. 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;

4. history of seizure, epilepsy, severe head injury, multiple sclerosis, or other known
neurological conditions;

5. abnormal pre-admission vital signs, physical examination, clinical laboratory, or any
safety variable which is considered clinically significant for this population by the
Principal Investigator or Sponsor (or designee). Subjects with an abnormal serum
creatinine should not be enrolled. Subjects with AST (SGOT), ALT (SGPT), GGT, alkaline
phosphatase, bilirubin, blood urea nitrogen (BUN), prothrombin time (PT), or activated
partial thromboplastin time (aPPT) >1.5 times above the upper limit of normal should
not be enrolled;

6. any subject with a clinically significant mental or physical illness within 1 year
prior to the first dose, including a history of alcohol and/or drug abuse within 1
year prior to the first dose of study medication;

7. Insulin requiring diabetics;

8. any subject who has received any known hepatic or renal clearance altering agents (eg,
erythromycin, cimetidine, barbiturates, phenothiazines, St. John's Wort, etc.) within
a period of 90 days prior to the first dose of study medication;

9. any subject who has received any approved prescription anti-obesity drug or has taken
any over-the-counter medication for weight loss or who has received a
thiazolidinedione or exanatide within a period of 90 days prior to the first dose of
study medication;

10. ingestion or use of any investigational medication or device within 60 days prior to
the first dose of study medication; ingestion or use of any investigational
anti-obesity medication is prohibited within 3 months prior to the first dose of study
medication;

11. any subject with history of malignancy in last 5 years, with exception of basal and
squamous cell carcinomas of the skin;

12. any subject who is positive for HBsAG, Hepatitis C antibody, Hepatitis A IgM, or Human
Immunodeficiency Virus (HIV) Viral Serology tests at the screening visit;

13. a positive qualitative urine drug or alcohol test at screening or at check-in;

14. mental capacity is limited to the extent that the subject cannot provide legal consent
or understand information regarding the study;

15. any subject who has had a 10% weight loss in the past 3 months prior to the screening
visit.