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This study has been withdrawn prior to enrollment.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)
Information provided by:
First received: March 15, 2010
Last updated: June 4, 2010
Last verified: June 2010
LIM-0705 will gain results on the effects of LIM-0705 on Male Subjects with Impaired Glucose Tolerance
|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
|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)|
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.
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