Investigation of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LIM-0705 in Male Subjects With Impaired Glucose Tolerance (LIM)
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|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Recruitment Status : Withdrawn (no subjects enrolled)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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01093677
|Study Director:||Albert Frauman, MD||Nucleus Network|