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- Title
PII-15.
- Authors
Kim, J. R.; Cho, J. Y.; Lim, K. S.; Kim, J. W.; Kim, B. H.; Shin, H. S.; Jeon, J. Y.; Chung, O. H.; Tae, Y. M.; Yu, K. S.; Shin, S. G.; Ahn, S. K.; Shin, J. S.; Jang, I. J.
- Abstract
Background: PPARα/γ dual agonists are new compounds for the treatment of diabetes mellitus. This study aimed to investigate safety, tolerability, and pharmacokinetics of CKD-501, a novel PPARα/γ dual agonist.Methods: A randomized, placebo-controlled, double-blind, parallel-group, single- and multiple-dose, dose-rising study was performed at the Clinical Trial Center of Seoul National University Hospital in Korea. Thirty-six healthy male subjects received single oral doses ranging from 0.5-8 mg CKD-501 or placebo. In the multiple-dose study, 24 subjects were administered 1 mg, 2 mg or 4 mg CKD-501 or placebo once daily for 7 days. Serial blood and urine samples were collected and safety was evaluated throughout the study.Results: No serious adverse events were observed and AEs reported were all of mild severity. In the single-dose study, mean Cmax and AUCinf increased up to 418 ug/L and 6154 ug·h/L at the 8 mg dose level, respectively. Tmax and t1/2 ranged from 0.5-4 hours and 7.8-9.8 hours, respectively. Less than 1% CKD-501 was excreted in urine. After multiple-dose administration, accumulation index was in the range of 1.1-1.4. Mean apparent clearance, Tmax and t1/2 in steady state were independent of dosage and not significantly different from those after first dosing.Conclusions: Single oral doses up to 8 mg CKD-501 and multiple doses up to 4 mg once daily for 7 days were safe and well tolerated. Mean Cmax and AUCinf were mainly dose proportional and there was no remarkable accumulation after multiple dosing.Clinical Pharmacology & Therapeutics (2005) 79, P39–P39; doi: 10.1016/j.clpt.2005.12.140
- Subjects
PHARMACEUTICAL research; PEROXISOMES; TREATMENT of diabetes; CHEMICAL agonists; PHARMACOKINETICS; PHARMACOLOGY; THERAPEUTICS
- Publication
Clinical Pharmacology & Therapeutics, 2006, Vol 79, Issue 2, pP39
- ISSN
0009-9236
- Publication type
Article
- DOI
10.1016/j.clpt.2005.12.140