A Study to Characterize the Pharmacokinetics of DA-8031 in Healthy Male Subjects
A Dose Block-randomized, Double-blind, Placebo-controlled, Single/Multiple Dosing, Dose-escalation Clinical Trial to Investigate the Safety, Tolerability, and Pharmacokinetic Characteristics of DA-8031 After Oral Administration in Healthy Male Subjects
1 other identifier
interventional
106
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 parameters of DA-8031 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 2010
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
First Submitted
Initial submission to the registry
April 12, 2010
CompletedFirst Posted
Study publicly available on registry
April 16, 2010
CompletedStudy Start
First participant enrolled
May 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2011
CompletedJuly 11, 2012
July 1, 2012
1.4 years
April 12, 2010
July 10, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
To characterize the pharmacokinetic parameters such as AUC(Area under concentration-time curve), Cmax, Tmax, T1/2, fe, and CL/F of DA-8031 by as assessment of plasma and urine concentration
Secondary Outcomes (1)
To evaluate the safety and tolerance of DA-8031 by assessment of vital signs, clinical laboratory tests, physical examinations, ECG findings, and adverse events collected by investigator questionnaire and subjects spontaneous report
Study Arms (2)
DA-8031
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- years healthy male subjects
- Body weight :60-90kg, BMI between 18.5-25
You may not qualify if:
- show SBP(Systolic Blood Pressure) =\<100mmHg or \>=140mmHg, or DBP(Diastolic Blood Pressure)=\<60mmHg or \>=90mmHg, or tachycardia (PR(Pulse Rate)\>=100times/min)
- have a history of drug abuse or show positive for drug abuse or cotinine at urine screening
- smokers
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Clinical Research Institute, Seoul National University Hospital
Seoul, Chongno-Gu, Yon-Gon Dong 28, 110-744, South Korea
MeSH Terms
Interventions
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 12, 2010
First Posted
April 16, 2010
Study Start
May 1, 2010
Primary Completion
October 1, 2011
Study Completion
October 1, 2011
Last Updated
July 11, 2012
Record last verified: 2012-07