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Clinical Trial to Investigate the Safety, Tolerability, and Pharmacokinetics of DWP09031

This study has been terminated.
(change development strategy)
Sponsor:
Information provided by (Responsible Party):
Daewoong Pharmaceutical Co. LTD.
ClinicalTrials.gov Identifier:
NCT01522586
First received: January 27, 2012
Last updated: February 12, 2014
Last verified: January 2012

January 27, 2012
February 12, 2014
January 2012
May 2013   (final data collection date for primary outcome measure)
Safety&tolerability [ Time Frame: -1d, 0 (predose), 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 h, 8d (post-study visit) ] [ Designated as safety issue: Yes ]
Adverse events, Physical exam, Vital sign, laboratory(CBC,chemistry,U/A etc)
Same as current
Complete list of historical versions of study NCT01522586 on ClinicalTrials.gov Archive Site
Pharmacokinetics [ Time Frame: 0 (predose), 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12 ,24 ,36, 48 h ] [ Designated as safety issue: Yes ]
Cmax, AUClast, AUCinf, t1/2, CL/F, Vd/F
Same as current
Not Provided
Not Provided
 
Clinical Trial to Investigate the Safety, Tolerability, and Pharmacokinetics of DWP09031
A Dose Block-randomized, Double-blind, Placebo-controlled, Single/Multiple Dosing, Dose-escalation Clinical Phase 1 Trial to Investigate the Safety, Tolerability, and Pharmacokinetics of DWP09031

The purpose of this study is to evaluate safety, tolerability, pharmacokinetics and pharmacodynamics of orally administrated DWP09031 in healthy male volunteers.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Healthy
  • Drug: DWP09031
    DWP09031 50mg/100mg/400mg/200mg/800mg/1200mg/1600mg/2000mg single dosing
  • Drug: Placebo
    placebo comparator 50mg/100mg/400mg/200mg/800mg/1200mg/1600mg/2000mg single dosing
  • Experimental: DWP09031
    DWP09031 50mg/100mg/400mg/200mg/800mg/1200mg/1600mg/2000mg single dosing
    Intervention: Drug: DWP09031
  • Placebo Comparator: Placebo
    placebo comparator 50mg/100mg/400mg/200mg/800mg/1200mg/1600mg/2000mg single dosing
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
74
December 2013
May 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Healthy adult male subjects aged 20 to 45 years
  2. The subject has Broca's index ≤ 20%
  3. A Subject who was judged to be healthy by the investigator to participate in this study based on screening results (according to standard reference index updated recently)
  4. A subject who provided written informed consent to participate in this study and cooperative with regard to compliance with study related constraints

Exclusion Criteria:

  1. A subject with sign or symptoms or previously diagnosed disease of liver (viral hepatitis), digestive system, cardiovascular, kidney, respiratory, endocrinology, neurology, immune system, hematology, and psychology function or other significant diseases and history or suspicion of current drug abuse and alcohol abuse
  2. A subject who shows vital signs with the number of systolic blood pressure of ≥141 mmHg or ≤89 mmHg, and the number of diastolic blood pressure of ≥91mmHg
  3. A subject who shows the following result in clinical laboratory test:

    AST,ALT>1.25 times of the upper limit of normal range PR ≥ 210 msec QRS ≥ 120 msec QT ≥ 500 msec QTcF ≥ 450 msec creatinine clearance ≤ 80mL/min

  4. Subject who has taken other clinical or licensed medication from another clinical trial within an 90-day period prior to the first administration of the study medication (The last administration of the medication is considered as an end point of the previous clinical trial).
Male
20 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01522586
DWP09031
Yes
Daewoong Pharmaceutical Co. LTD.
Daewoong Pharmaceutical Co. LTD.
Not Provided
Principal Investigator: Jae-Gook Shin, Professor BUSAN PAIK HOSPITAL
Daewoong Pharmaceutical Co. LTD.
January 2012

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