A Study to Characterize the Pharmacokinetics/Pharmacodynamics and Effect of Food of DA-1229 in Healthy Male Subjects
A Dose Block-randomized, Double-blind, Placebo-controlled, Single/Multiple Dosing, Dose Escalation Clinical Phase 1 Study to Investigate the Safety, Tolerance, and Pharmacokinetics/Pharmacodynamics of DA-1229 in Healthy Male Subjects
1 other identifier
interventional
110
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started May 2009
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2009
CompletedFirst Submitted
Initial submission to the registry
August 10, 2009
CompletedFirst Posted
Study publicly available on registry
August 18, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2010
CompletedAugust 24, 2009
August 1, 2009
9 months
August 10, 2009
August 20, 2009
Conditions
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (1)
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)
Study Arms (2)
Placebo
PLACEBO COMPARATORDA-1229
EXPERIMENTALDA-1229
Interventions
Eligibility Criteria
You may qualify if:
- years healthy male subjects
- Body weight :50-90kg, BMI between 18.5-25
- Blood glucose level of 70-110mg/dL on the FPG test
You may not qualify if:
- have a family history of diabetes
- Serum AST(SGOT), ALT(SGPT)\>1.25 times upper limit of normal
- Creatinine clearance rate\<80mL/min
- show SBP =\<100mmHg or \>=150mmHg, or DBP=\<65mmHg or \>=95mmHg, or tachycardia (PR\>=100times/min)
- have a history of drug abuse or show positive for drug abuse or cotinine at urine screening
- smokers
- can not digest high-fat or high-calorie food(applicable only for the 10mg dose group subjects
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Clinical Trials Center, Seoul National University Hospital
Seoul, Chongo-Gu, Yon-Gon Dong, 110-744, South Korea
Related Publications (1)
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.
PMID: 22943970DERIVED
MeSH Terms
Interventions
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
August 10, 2009
First Posted
August 18, 2009
Study Start
May 1, 2009
Primary Completion
February 1, 2010
Study Completion
March 1, 2010
Last Updated
August 24, 2009
Record last verified: 2009-08