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
  Purpose

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


Condition Intervention Phase
Healthy
Drug: DWP09031
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Official Title: 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

Further study details as provided by Daewoong Pharmaceutical Co. LTD.:

Primary Outcome Measures:
  • 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)


Secondary Outcome Measures:
  • 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


Enrollment: 74
Study Start Date: January 2012
Study Completion Date: December 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: DWP09031
DWP09031 50mg/100mg/400mg/200mg/800mg/1200mg/1600mg/2000mg single dosing
Drug: DWP09031
DWP09031 50mg/100mg/400mg/200mg/800mg/1200mg/1600mg/2000mg single dosing
Placebo Comparator: Placebo
placebo comparator 50mg/100mg/400mg/200mg/800mg/1200mg/1600mg/2000mg single dosing
Drug: Placebo
placebo comparator 50mg/100mg/400mg/200mg/800mg/1200mg/1600mg/2000mg single dosing

  Eligibility

Ages Eligible for Study:   20 Years to 45 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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).
  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: NCT01522586

Locations
Korea, Republic of
Inje University College of Medicine Busan Paik Hospital
Busan, Busanjin-gu, Korea, Republic of, 614-735
Sponsors and Collaborators
Daewoong Pharmaceutical Co. LTD.
Investigators
Principal Investigator: Jae-Gook Shin, Professor BUSAN PAIK HOSPITAL
  More Information

No publications provided

Responsible Party: Daewoong Pharmaceutical Co. LTD.
ClinicalTrials.gov Identifier: NCT01522586     History of Changes
Other Study ID Numbers: DWP09031
Study First Received: January 27, 2012
Last Updated: February 12, 2014
Health Authority: United States: Food and Drug Administration
South Korea: Korea Food and Drug Administration (KFDA)

ClinicalTrials.gov processed this record on September 30, 2014