Investigation of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LIM-0705 in Male Subjects With Impaired Glucose Tolerance (LIM)
|ClinicalTrials.gov Identifier: NCT01093677|
Recruitment Status : Withdrawn (no subjects enrolled)
First Posted : March 26, 2010
Last Update Posted : June 8, 2010
|Condition or disease||Intervention/treatment||Phase|
|Impaired Glucose Tolerance||Drug: LIM-0705 Drug: Placebo||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|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 Start Date :||March 2010|
|Estimated Primary Completion Date :||June 2010|
|Estimated Study Completion Date :||July 2010|
750 mg of LIM-0705 BID for 14 days. Up to 20 subjects.
Oral solution 750 mg LIM 0705 BID for 14 days.
Placebo Comparator: B
Placebo BID for 14 days. Up to 10 subjects.
Oral solution placebo BID for 14 days.
- 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 ]
- 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
- Incidence of treatment emergent adverse events and pharmacokinetics of LIM-0705 and its major metabolite [ Time Frame: approx. 1 month ]
- 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01093677
|Study Director:||Albert Frauman, MD||Nucleus Network|