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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
Sponsor:
Information provided by (Responsible Party):
Dong-A ST Co., Ltd. ( Dong-A Pharmaceutical Co., Ltd. )

Tracking Information
First Submitted Date  ICMJE July 2, 2012
First Posted Date  ICMJE July 4, 2012
Last Update Posted Date August 13, 2013
Study Start Date  ICMJE August 2012
Estimated Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 3, 2012)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 3, 2012)
Pharmacokinetics and Pharmacodynamics [ Time Frame: up to 48 hours after last dosing of DA-6886 ]
Cmax, Tmax, AUClast, Ae, Cssmax, Cssmin
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Phase I Clinical Trial of DA-6886 in Healthy Male Subjects
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Irritable Bowel Syndrome
Intervention  ICMJE
  • 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)

  • Drug: Placebo of DA-6886
    DA-6886 placebo
Study Arms  ICMJE
  • Experimental: DA-6886
    Intervention: Drug: DA-6886
  • Placebo Comparator: DA-6886 placebo
    Intervention: Drug: Placebo of DA-6886
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: July 3, 2012)
88
Original Estimated Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Estimated Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 20 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01633723
Other Study ID Numbers  ICMJE DA6886_IBS_I
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dong-A ST Co., Ltd. ( Dong-A Pharmaceutical Co., Ltd. )
Study Sponsor  ICMJE Dong-A Pharmaceutical Co., Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Dong-A ST Co., Ltd.
Verification Date August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP