Investigation of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LIM-0705 in Male Subjects With Impaired Glucose Tolerance

Impaired Glucose Tolerance Clinical Trial

— LIM  

Official title:

A Single-Blind,Randomized,Placebo-Controlled Phase 1 Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Exploratory Pharmacodynamics of LIM-0705 in Male Subjects With Impaired Glucose Tolerance

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01093677
• Other study ID #: LIM-0705-CL-003
• Status: Withdrawn
• Phase: Phase 1
• First received: March 15, 2010
• Last updated: June 4, 2010
• Start date: March 2010
• Est. completion date: July 2010

Study information

• Verified date: June 2010
• Source: Limerick BioPharma
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Department of Health and Ageing Therapeutic Goods AdministrationAustralia: Human Research Ethics Committee
• Study type: Interventional

Clinical Trial Summary

LIM-0705 will gain results on the effects of LIM-0705 on Male Subjects with Impaired Glucose Tolerance

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 30
• Est. completion date: July 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

1. Males, age 18-70 years old

2. Measured waist circumference to hip circumference ratio >0.90

3. Body mass index (BMI) of 27 - 40 kg/m2

4. Screening and Day -1 capillary glucose measurement between 110-160 mg/dL (6.1-8.9 mmol/L) after a 12 hour fast

5. Screening and Day -1 OGTT with a 2 hour post-glucose measurement =140 mg/dL (7.8 mmol/L) after a 12 hour fast

6. Screening HbA1c > 6 and = 7.5%

7. Subjects must be in reasonably good health as determined by pre-study medical history, physical examination, 12-lead ECG, and the following laboratory measures:

• Electrolytes, ALP, LDH, creatinine, and urea must be within normal range without medication

• Urinalysis within normal limits

8. Willing to remain in confinement at the clinical study unit for up to 18 days/17 nights and to return to the unit as specified for additional assessments

9. Willing to consume only the food that is provided by the clinical study unit

10. Non-smokers or "social smokers" (defined as fewer than 5 cigarettes per week) willing to abstain from smoking for the duration of study

11. Willing to abstain from alcohol-containing, grapefruit-containing, or caffeine-containing foods or beverages

12. Able to read, understand and follow the study instructions

13. Agree to use of two effective methods of contraception

Exclusion Criteria:

1. Allergy to onions or red wine

2. Strict vegetarians (i.e., subjects who do not eat meat, fish, fowl, or dairy)

3. Use of any non-study medication(s) during the study period other than those approved by the Investigator for treatment of an adverse event (AE)

4. Use of chemotherapy agents or history of cancer, other than non-metastatic non-melanoma skin cancer that has been completely excised, within five (5) years prior to the Screening visit

5. Use of any dietary aids or foods known to modulate drug metabolizing enzymes (e.g., St. John's Wort, grapefruit juice) within 4 days of randomization

6. History of bacterial or viral infection requiring treatment with antibiotics or antivirals within 30 days of randomization

7. Difficulty in swallowing oral medications

8. History of seizure disorder

9. Moderate to severe gastro-esophageal reflux disease

10. History of arrhythmia

11. Cognitive or psychiatric disorders, or any other condition that could interfere with compliance with study procedures and/or confinement in a clinical study unit

12. Baseline liver enzymes greater than the upper limit of normal

13. Baseline creatine phosphokinase (CPK) greater than 2.5x the upper limit of normal

14. History of drug or alcohol abuse

15. Use of any other investigational drug within 30 days of randomization or investigational biologic within 180 days of randomization

16. Use of over-the-counter (OTC) medications or nutraceuticals, excluding routine vitamins, within 14 days of randomization or 5 half-lives of the drug, whichever is longer

17. Use of prescription pharmaceuticals within 30 days of randomization

18. Donation and/or receipt of any blood or blood products within 90 days of randomization

19. Current gastrointestinal (GI), renal, hepatic, or coagulant disorder within 12 months of randomization

20. History of peptic or duodenal ulcer or GI bleed

21. Subjects with Gilbert's Syndrome

22. Subjects with positive drug or alcohol screen

23. Subject positive for hepatitis C antibody (HCV), hepatitis B surface antigen (HBsAg), or human immunodeficiency virus (HIV) antibody

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glucose Intolerance
• Impaired Glucose Tolerance

Intervention

Drug:
• LIM-0705
Oral solution 750 mg LIM 0705 BID for 14 days.
• Placebo
Oral solution placebo BID for 14 days.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Limerick BioPharma

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the effect of LIM-0705 on glucose metabolism, lipid metabolism and renal function in subjects with impaired glucose tolerance	Assessment of glucose metabolism will be based on monitoring of overnight-fasting glucose levels and on performance of an Oral Glucose Tolerance Test (OGTT); Assessment of lipid metabolism will be based on 12 hour-fasting lipid profiles (including LDL, HDL, total cholesterol, free fatty acids, and triglycerides); Assessment of renal function will be performed by monitoring serum BUN and creatinine levels	approx. 1 month	Yes
Secondary	Incidence of treatment emergent adverse events and pharmacokinetics of LIM-0705 and its major metabolite	To evaluate the incidence of treatment emergent adverse events; as well as changes in physical examination findings, vital signs, ECGs, and clinical laboratory tests (serum chemistry, hematology urinalysis, and coagulation); To characterize the pharmacokinetics of LIM-0705 and its major metabolite	approx. 1 month	Yes