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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by Dong-A ST Co., Ltd.
Sponsor:
Information provided by (Responsible Party):
Dong-A ST Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01633723
First received: July 2, 2012
Last updated: August 12, 2013
Last verified: August 2013
  Purpose

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.


Condition Intervention Phase
Irritable Bowel Syndrome
Drug: DA-6886
Drug: Placebo of DA-6886
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
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

Further study details as provided by Dong-A ST Co., Ltd.:

Primary Outcome Measures:
  • Assessment of safety [ Time Frame: up to 7 days (single dose study, single dose study for food effect), 15 days (multiple dose study) ] [ Designated as safety issue: Yes ]
    1. Adverse Events
    2. Laboratory Results
    3. Vital sign, Physical Examination, EKG


Secondary Outcome Measures:
  • Pharmacokinetics and Pharmacodynamics [ Time Frame: up to 48 hours after last dosing of DA-6886 ] [ Designated as safety issue: No ]
    Cmax, Tmax, AUClast, Ae, Cssmax, Cssmin


Estimated Enrollment: 88
Study Start Date: August 2012
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: DA-6886 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 Comparator: DA-6886 placebo Drug: Placebo of DA-6886
DA-6886 placebo

  Eligibility

Ages Eligible for Study:   20 Years to 45 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01633723

Contacts
Contact: Kyun-Seop Bae, M.D., Ph.d. +82-2-3010-4611 ksbae@amc.seoul.kr

Locations
Korea, Republic of
ASAN medical center Recruiting
Seoul, Songpa-gu, Korea, Republic of, 138-736
Contact: Kyun-Seop Bae, M.D., Ph.D.    +82-2-3010-4611    ksbae@amc.seoul.kr   
Sponsors and Collaborators
Dong-A ST Co., Ltd.
  More Information

No publications provided

Responsible Party: Dong-A ST Co., Ltd.
ClinicalTrials.gov Identifier: NCT01633723     History of Changes
Other Study ID Numbers: DA6886_IBS_I
Study First Received: July 2, 2012
Last Updated: August 12, 2013
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Additional relevant MeSH terms:
Irritable Bowel Syndrome
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on September 15, 2014