Investigation of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LIM-0705 in Male Subjects With Impaired Glucose Tolerance (LIM)
Primary Purpose
Impaired Glucose Tolerance
Status
Withdrawn
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
LIM-0705
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Impaired Glucose Tolerance
Eligibility Criteria
Inclusion Criteria:
- Males, age 18-70 years old
- Measured waist circumference to hip circumference ratio >0.90
- Body mass index (BMI) of 27 - 40 kg/m2
- Screening and Day -1 capillary glucose measurement between 110-160 mg/dL (6.1-8.9 mmol/L) after a 12 hour fast
- Screening and Day -1 OGTT with a 2 hour post-glucose measurement ≥140 mg/dL (7.8 mmol/L) after a 12 hour fast
- Screening HbA1c > 6 and ≤ 7.5%
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
- 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
- Willing to consume only the food that is provided by the clinical study unit
- Non-smokers or "social smokers" (defined as fewer than 5 cigarettes per week) willing to abstain from smoking for the duration of study
- Willing to abstain from alcohol-containing, grapefruit-containing, or caffeine-containing foods or beverages
- Able to read, understand and follow the study instructions
- Agree to use of two effective methods of contraception
Exclusion Criteria:
- Allergy to onions or red wine
- Strict vegetarians (i.e., subjects who do not eat meat, fish, fowl, or dairy)
- 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)
- 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
- 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
- History of bacterial or viral infection requiring treatment with antibiotics or antivirals within 30 days of randomization
- Difficulty in swallowing oral medications
- History of seizure disorder
- Moderate to severe gastro-esophageal reflux disease
- History of arrhythmia
- Cognitive or psychiatric disorders, or any other condition that could interfere with compliance with study procedures and/or confinement in a clinical study unit
- Baseline liver enzymes greater than the upper limit of normal
- Baseline creatine phosphokinase (CPK) greater than 2.5x the upper limit of normal
- History of drug or alcohol abuse
- Use of any other investigational drug within 30 days of randomization or investigational biologic within 180 days of randomization
- 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
- Use of prescription pharmaceuticals within 30 days of randomization
- Donation and/or receipt of any blood or blood products within 90 days of randomization
- Current gastrointestinal (GI), renal, hepatic, or coagulant disorder within 12 months of randomization
- History of peptic or duodenal ulcer or GI bleed
- Subjects with Gilbert's Syndrome
- Subjects with positive drug or alcohol screen
- Subject positive for hepatitis C antibody (HCV), hepatitis B surface antigen (HBsAg), or human immunodeficiency virus (HIV) antibody
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
A
B
Arm Description
750 mg of LIM-0705 BID for 14 days. Up to 20 subjects.
Placebo BID for 14 days. Up to 10 subjects.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01093677
Brief Title
Investigation of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LIM-0705 in Male Subjects With Impaired Glucose Tolerance
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2010
Overall Recruitment Status
Withdrawn
Why Stopped
no subjects enrolled
Study Start Date
March 2010 (undefined)
Primary Completion Date
June 2010 (Anticipated)
Study Completion Date
July 2010 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Limerick BioPharma
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
LIM-0705 will gain results on the effects of LIM-0705 on Male Subjects with Impaired Glucose Tolerance
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Impaired Glucose Tolerance
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Experimental
Arm Description
750 mg of LIM-0705 BID for 14 days. Up to 20 subjects.
Arm Title
B
Arm Type
Placebo Comparator
Arm Description
Placebo BID for 14 days. Up to 10 subjects.
Intervention Type
Drug
Intervention Name(s)
LIM-0705
Intervention Description
Oral solution 750 mg LIM 0705 BID for 14 days.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Oral solution placebo BID for 14 days.
Primary Outcome Measure Information:
Title
To evaluate the effect of LIM-0705 on glucose metabolism, lipid metabolism and renal function in subjects with impaired glucose tolerance
Description
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
Time Frame
approx. 1 month
Secondary Outcome Measure Information:
Title
Incidence of treatment emergent adverse events and pharmacokinetics of LIM-0705 and its major metabolite
Description
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
Time Frame
approx. 1 month
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Males, age 18-70 years old
Measured waist circumference to hip circumference ratio >0.90
Body mass index (BMI) of 27 - 40 kg/m2
Screening and Day -1 capillary glucose measurement between 110-160 mg/dL (6.1-8.9 mmol/L) after a 12 hour fast
Screening and Day -1 OGTT with a 2 hour post-glucose measurement ≥140 mg/dL (7.8 mmol/L) after a 12 hour fast
Screening HbA1c > 6 and ≤ 7.5%
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
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
Willing to consume only the food that is provided by the clinical study unit
Non-smokers or "social smokers" (defined as fewer than 5 cigarettes per week) willing to abstain from smoking for the duration of study
Willing to abstain from alcohol-containing, grapefruit-containing, or caffeine-containing foods or beverages
Able to read, understand and follow the study instructions
Agree to use of two effective methods of contraception
Exclusion Criteria:
Allergy to onions or red wine
Strict vegetarians (i.e., subjects who do not eat meat, fish, fowl, or dairy)
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)
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
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
History of bacterial or viral infection requiring treatment with antibiotics or antivirals within 30 days of randomization
Difficulty in swallowing oral medications
History of seizure disorder
Moderate to severe gastro-esophageal reflux disease
History of arrhythmia
Cognitive or psychiatric disorders, or any other condition that could interfere with compliance with study procedures and/or confinement in a clinical study unit
Baseline liver enzymes greater than the upper limit of normal
Baseline creatine phosphokinase (CPK) greater than 2.5x the upper limit of normal
History of drug or alcohol abuse
Use of any other investigational drug within 30 days of randomization or investigational biologic within 180 days of randomization
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
Use of prescription pharmaceuticals within 30 days of randomization
Donation and/or receipt of any blood or blood products within 90 days of randomization
Current gastrointestinal (GI), renal, hepatic, or coagulant disorder within 12 months of randomization
History of peptic or duodenal ulcer or GI bleed
Subjects with Gilbert's Syndrome
Subjects with positive drug or alcohol screen
Subject positive for hepatitis C antibody (HCV), hepatitis B surface antigen (HBsAg), or human immunodeficiency virus (HIV) antibody
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Albert Frauman, MD
Organizational Affiliation
Nucleus Network
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
Investigation of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LIM-0705 in Male Subjects With Impaired Glucose Tolerance
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