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

Sponsor
Daewoong Pharmaceutical Co. LTD. (Industry)
Overall Status
Terminated
CT.gov ID
NCT01522586
Collaborator
(none)
74
Enrollment
1
Location
2
Arms
23
Duration (Months)
3.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
74 participants
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Masking:
Double (Participant, 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
Study Start Date :
Jan 1, 2012
Actual Primary Completion Date :
May 1, 2013
Actual Study Completion Date :
Dec 1, 2013

Arms and Interventions

Arm Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

  1. Safety&tolerability [-1d, 0 (predose), 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 h, 8d (post-study visit)]

    Adverse events, Physical exam, Vital sign, laboratory(CBC,chemistry,U/A etc)

Secondary Outcome Measures

  1. Pharmacokinetics [0 (predose), 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12 ,24 ,36, 48 h]

    Cmax, AUClast, AUCinf, t1/2, CL/F, Vd/F

Eligibility Criteria

Criteria

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

  1. 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

Locations

Site City State Country Postal Code
1 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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Daewoong Pharmaceutical Co. LTD.
ClinicalTrials.gov Identifier:
NCT01522586
Other Study ID Numbers:
  • DWP09031
First Posted:
Jan 31, 2012
Last Update Posted:
Feb 13, 2014
Last Verified:
Jan 1, 2012

Study Results

No Results Posted as of Feb 13, 2014