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

This study has been withdrawn prior to enrollment.
(no subjects enrolled)
Sponsor:
Information provided by:
Limerick BioPharma
ClinicalTrials.gov Identifier:
NCT01093677
First received: March 15, 2010
Last updated: June 4, 2010
Last verified: June 2010
  Purpose

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


Condition Intervention Phase
Impaired Glucose Tolerance
Drug: LIM-0705
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
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

Further study details as provided by Limerick BioPharma:

Primary Outcome Measures:
  • To evaluate the effect of LIM-0705 on glucose metabolism, lipid metabolism and renal function in subjects with impaired glucose tolerance [ Time Frame: approx. 1 month ] [ Designated as safety issue: Yes ]
    • 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


Secondary Outcome Measures:
  • Incidence of treatment emergent adverse events and pharmacokinetics of LIM-0705 and its major metabolite [ Time Frame: approx. 1 month ] [ Designated as safety issue: Yes ]
    • 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


Estimated Enrollment: 30
Study Start Date: March 2010
Estimated Study Completion Date: July 2010
Estimated Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
750 mg of LIM-0705 BID for 14 days. Up to 20 subjects.
Drug: LIM-0705
Oral solution 750 mg LIM 0705 BID for 14 days.
Placebo Comparator: B
Placebo BID for 14 days. Up to 10 subjects.
Drug: Placebo
Oral solution placebo BID for 14 days.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01093677

Sponsors and Collaborators
Limerick BioPharma
Investigators
Study Director: Albert Frauman, MD Nucleus Network
  More Information

No publications provided

Responsible Party: Wendye Rae Robbins, MD, Limerick BioPharma
ClinicalTrials.gov Identifier: NCT01093677     History of Changes
Other Study ID Numbers: LIM-0705-CL-003
Study First Received: March 15, 2010
Last Updated: June 4, 2010
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
Australia: Human Research Ethics Committee

Additional relevant MeSH terms:
Glucose Intolerance
Hyperglycemia
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on April 21, 2014