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NCT01633723 Clinical Trial

Phase I Clinical Trial of DA-6886 in Healthy Male Subjects

Irritable Bowel Syndrome Clinical Trial

Official title:
A Phase I, Dose Block-randomized, Double-blind, Placebo-controlled, Single/Multiple Dosing, Dose Escalation Clinical Trial With Open-labelled Food Effect Study of Single Dose to Investigate the Safety, Tolerability and Pharmacokinetics of DA-6886 After Oral Administration in Healthy Male Subjects

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01633723
Other study ID # DA6886_IBS_I
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date August 2012
Est. completion date April 2014

Study information
Verified date April 2021
Source Dong-A ST Co., Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

DA-6886_IBS_I is a phase I, dose block-randomized, double-blind, placebo-controlled, single/multiple dosing, dose escalation clinical trial with open-labelled food effect study of single dose to investigate the safety, tolerability and pharmacokinetics of DA-6886 after oral administration in healthy male subjects.

Recruitment information / eligibility
Status Completed
Enrollment 105
Est. completion date April 2014
Est. primary completion date April 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 20 Years to 45 Years
Eligibility Inclusion Criteria: - 20 ~ 45 years old - 27kg/m2 = BMI = 20kg/m2 - Healthy Male - Informed consent Exclusion Criteria: - Clinically significant medical history - smokers - Clinically significant hypersensitivity of Drugs - Clinically significant cutaneous disorder - QTcB > 450msec - have a history of drug abuse or show positive for drug abuse or cotinine at urine screening

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• DA-6886
single dose study : DA-6886 1mg,2.5mg,5mg,10mg,20mg dosage (Dose-escalation) multiple dose study : DA-6886 2.5mg,5mg,10mg or 5mg,10mg,20mg dosage (Dose-escalation)
• Placebo of DA-6886
DA-6886 placebo

Locations
Country Name City State
Korea, Republic of ASAN medical center Seoul Songpa-gu

Sponsors (1)
Lead Sponsor Collaborator
Dong-A ST Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Assessment of safety Adverse Events
Laboratory Results
Vital sign, Physical Examination, EKG		 up to 7 days (single dose study, single dose study for food effect), 15 days (multiple dose study)
Secondary Pharmacokinetics and Pharmacodynamics Cmax, Tmax, AUClast, Ae, Cssmax, Cssmin up to 48 hours after last dosing of DA-6886
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