A Study to Characterize the Pharmacokinetics/Pharmacodynamics and Effect of Food of DA-1229 in Healthy Male Subjects

Phase 1 Unknown 110 enrolled Dong-A Pharmaceutical Co., Ltd.

RandomizedParallel-groupDouble-blindTreatment

Summary

This is a dose block-randomized, double-blind, placebo-controlled, single/multiple dosing, dose-escalation study. The study is designed to describe the relationship between multiple doses and pharmacokinetic/pharmacodynamic parameters of DA-1229 as well as safety profile.

Timeline

Start: 2009-05
Primary completion: 2010-02
Completion: 2010-03

Publications

Kim TE, Lim KS, Park MK, Yoon SH, Cho JY, Shin SG, Jang IJ, Yu KS. Evaluation of the pharmacokinetics, food effect, pharmacodynamics, and tolerability of DA-1229, a dipeptidyl peptidase IV inhibitor, in healthy volunteers: first-in-human study. Clin Ther. 2012 Sep;34(9):1986-98. doi: 10.1016/j.clinthera.2012.08.006. Epub 2012 Sep 1.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Evogliptin	Small molecule	1.25 mg	Oral
Subject	Evogliptin	Small molecule	2.5 mg	Oral
Subject	Evogliptin	Small molecule	5 mg	Oral
Subject	Evogliptin	Small molecule	10 mg	Oral
Subject	Evogliptin	Small molecule	20 mg	Oral
Subject	Evogliptin	Small molecule	40 mg	Oral
Subject	Evogliptin	Small molecule	60 mg	Oral

A Study to Characterize the Pharmacokinetics/Pharmacodynamics and Effect of Food of DA-1229 in Healthy Male Subjects

Summary

Timeline

Publications

Drugs

Indications