Phase I Clinical Trial of DA-6886 in Healthy Male Subjects
Primary Purpose
Irritable Bowel Syndrome
Status
Completed
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
DA-6886
Placebo of DA-6886
Sponsored by

About this trial
This is an interventional treatment trial for Irritable Bowel Syndrome
Eligibility Criteria
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
Sites / Locations
- ASAN medical center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
DA-6886
DA-6886 placebo
Arm Description
Outcomes
Primary Outcome Measures
Assessment of safety
Adverse Events
Laboratory Results
Vital sign, Physical Examination, EKG
Secondary Outcome Measures
Pharmacokinetics and Pharmacodynamics
Cmax, Tmax, AUClast, Ae, Cssmax, Cssmin
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01633723
Brief Title
Phase I Clinical Trial of DA-6886 in Healthy Male Subjects
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
August 2012 (undefined)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
April 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dong-A ST Co., Ltd.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Irritable Bowel Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Factorial Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
105 (Actual)
8. Arms, Groups, and Interventions
Arm Title
DA-6886
Arm Type
Experimental
Arm Title
DA-6886 placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
DA-6886
Intervention Description
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)
Intervention Type
Drug
Intervention Name(s)
Placebo of DA-6886
Intervention Description
DA-6886 placebo
Primary Outcome Measure Information:
Title
Assessment of safety
Description
Adverse Events
Laboratory Results
Vital sign, Physical Examination, EKG
Time Frame
up to 7 days (single dose study, single dose study for food effect), 15 days (multiple dose study)
Secondary Outcome Measure Information:
Title
Pharmacokinetics and Pharmacodynamics
Description
Cmax, Tmax, AUClast, Ae, Cssmax, Cssmin
Time Frame
up to 48 hours after last dosing of DA-6886
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
ASAN medical center
City
Seoul
State/Province
Songpa-gu
ZIP/Postal Code
138-736
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Phase I Clinical Trial of DA-6886 in Healthy Male Subjects
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