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

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ClinicalTrials.gov Identifier: NCT01633723
Recruitment Status : Unknown
Verified August 2013 by Dong-A ST Co., Ltd. ( Dong-A Pharmaceutical Co., Ltd. ).
Recruitment status was:  Recruiting
First Posted : July 4, 2012
Last Update Posted : August 13, 2013
Information provided by (Responsible Party):
Dong-A ST Co., Ltd. ( Dong-A Pharmaceutical Co., Ltd. )

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.

Condition or disease Intervention/treatment Phase
Irritable Bowel Syndrome Drug: DA-6886 Drug: Placebo of DA-6886 Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 88 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Triple (Participant, Care Provider, 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
Study Start Date : August 2012
Estimated Primary Completion Date : December 2013

Arm Intervention/treatment
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

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

Secondary Outcome Measures :
  1. Pharmacokinetics and Pharmacodynamics [ Time Frame: up to 48 hours after last dosing of DA-6886 ]
    Cmax, Tmax, AUClast, Ae, Cssmax, Cssmin

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01633723

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

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.

Responsible Party: Dong-A Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT01633723     History of Changes
Other Study ID Numbers: DA6886_IBS_I
First Posted: July 4, 2012    Key Record Dates
Last Update Posted: August 13, 2013
Last Verified: August 2013

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