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

This study is currently recruiting participants.
Verified August 2013 by Dong-A Pharmaceutical Co., Ltd.
Sponsor:
Information provided by (Responsible Party):
Dong-A Pharmaceutical 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 Pharmaceutical 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
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 Pharmaceutical Co., Ltd.
  More Information

No publications provided

Responsible Party: Dong-A Pharmaceutical 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 April 17, 2014