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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
Dong-A ST Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Irritable Bowel Syndrome

Eligibility Criteria

20 Years - 45 Years (Adult)MaleAccepts Healthy Volunteers

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

First Posted
July 2, 2012
Last Updated
April 13, 2021
Sponsor
Dong-A ST Co., Ltd.
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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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