A Single Dose Study of DWP10292 in Healthy Male Subjects

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Daewoong Pharmaceutical Co. LTD.
ClinicalTrials.gov Identifier:
NCT01423526
First received: August 24, 2011
Last updated: February 23, 2014
Last verified: August 2011
  Purpose

The purpose of this study is to evaluate safety, tolerability, pharmacokinetics and pharmacodynamics of orally administrated DWP10292 in healthy male volunteers.


Condition Intervention Phase
Healthy
Drug: DWP10292
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, Caregiver, Investigator)
Primary Purpose: Basic Science
Official Title: A Dose Block-randomized, Double-blind, Placebo Controlled, Single-dosing, Dose-escalation Clinical Trial to Investigate the Safety, Tolerability and Pharmacokinetic Characteristics of DWP10292 After Oral Administration in Healthy Male Subjects

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

Primary Outcome Measures:
  • Composite of Pharmacokinetics [ Time Frame: 0 (predose), 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 14, 16, 24 (2d 0h), 36, 48 (3d 0h), 60, 72 (4d 0h), 96 h(5d 0h) and Post study visit 216h (10d 0h) ] [ Designated as safety issue: Yes ]
    Cmax, AUClast, AUCinf, Tmax, t1/2, CL/F


Secondary Outcome Measures:
  • Safety&tolerability [ Time Frame: 0 (predose), 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 14, 16, 24 (2d 0h), 36, 48 (3d 0h), 60, 72 (4d 0h), 96 h(5d 0h) Post study visit 216h (10d 0h) ] [ Designated as safety issue: Yes ]
    Adverse events, Physical exam, Vital sign, laboratory(CBC,chemistry,U/A etc)


Enrollment: 52
Study Start Date: August 2011
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo

Drug: Placebo tablets, oral administration, single administrations

Arms: Placebo

Drug: Placebo
Placebo tablets, oral administration, single administrations
Experimental: DWP10292

Drug: DWP10292 tablets, oral administration, single administrations

Arms: DWP10292

Drug: DWP10292
Drug: DWP10292 tablets, oral administration, single administration

  Eligibility

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

Inclusion Criteria:

  • A subject who provided written informed consent to participate in this study and cooperative with regard to compliance with study related constraints
  • Healthy adult male subjects aged 20 to 45 years
  • The subject has a Body weight ≥ 60 kg and < 90 kg and Body Mass Index (BMI) ≥ 18.5 kg/m2 and < 27.0 kg/m2
  • 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)

Exclusion Criteria:

  • 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
  • A subject who shows vital signs with the number of systolic blood pressure of ≥140 mmHg or ≤100 mmHg, and the number of diastolic blood pressure of ≥90mmHg or ≤60mmHg
  • A subject who shows the following result in clinical laboratory test:

    • AST,ALT>1.25 times of the upper limit of normal range
    • QTc>430msec
    • T.bil>1.25 times of the upper limit of normal range
  • A subject from whom over 400mL of blood was sampled(whole blood or plasma donation, etc.) within last 8 weeks
  • Subject who has taken other clinical or licensed medication from another clinical trial within an 8-week 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).
  • Subject who smokes an average of 10 cigarettes/day and is unable to quit smoking during the 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: NCT01423526

Locations
Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Daewoong Pharmaceutical Co. LTD.
Investigators
Principal Investigator: Kyung-Sang Yu Seoul National University Hospital
  More Information

No publications provided

Responsible Party: Daewoong Pharmaceutical Co. LTD.
ClinicalTrials.gov Identifier: NCT01423526     History of Changes
Other Study ID Numbers: DWP10292
Study First Received: August 24, 2011
Last Updated: February 23, 2014
Health Authority: United States: Food and Drug Administration
South Korea: Korea Food and Drug Administration (KFDA)

ClinicalTrials.gov processed this record on August 19, 2014