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

NCT01093677 | Withdrawn Phase 1

• 1 other identifier: LIM-0705-CL-003
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Impaired Glucose Tolerance

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Incidence of treatment emergent adverse events and pharmacokinetics of LIM-0705 and its major metabolite

  approx. 1 month

Study Arms (2)

A

EXPERIMENTAL

750 mg of LIM-0705 BID for 14 days. Up to 20 subjects.

Drug: LIM-0705

B

PLACEBO COMPARATOR

Placebo BID for 14 days. Up to 10 subjects.

Drug: Placebo

Interventions

LIM-0705 DRUG

Oral solution 750 mg LIM 0705 BID for 14 days.

A

Placebo DRUG

Oral solution placebo BID for 14 days.

B

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Limerick BioPharma: lead

MeSH Terms

Conditions

Glucose Intolerance

Condition Hierarchy (Ancestors)

Hyperglycemia; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Albert Frauman, MD

  Nucleus Network

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 15, 2010
• First Posted: March 26, 2010
• Study Start: March 1, 2010
• Primary Completion: June 1, 2010
• Study Completion: July 1, 2010
• Last Updated: June 8, 2010

Record last verified: 2010-06