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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator |
| |
| DA-1229 | Experimental | DA-1229 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DA-1229 | Drug | single dose study : DA-1229 1.25,2.5,5,10,20,40,60mg multiple dose study : DA-1229 5,10,20,40mg |
|
| Measure | Description | Time Frame |
|---|---|---|
| To characterize the pharmacokinetic/pharmacodynamic of DA-1229 in healthy male subjects | Multiple blood and urine samples will be collected for 120 hours after dosing of DA-1229 |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the safety and tolerance of DA-1229 | up to 10 days (single dose study), 17 days (single dose study for food effect), 20 days (multiple dose study) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kyung-Sang Yu, M.D., Ph.d., M.B.A. | Contact | +82-2-2072-1920 | ksyu@snuh.ac.kr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Trials Center, Seoul National University Hospital | Recruiting | Seoul | Chongo-Gu, Yon-Gon Dong | 110-744 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22943970 | Derived | 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. |
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| ID | Term |
|---|---|
| C557982 | 4-(3-amino-4-(2,4,5-trifluorophenyl)butanoyl)-3-(tert-butoxymethyl)piperazin-2-one |
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| Placebo | Drug | placebo |
|