A Single Dose Study of DWP10292 in Healthy Male Subjects

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

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

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Placebo; Drug: DWP10292

• Study Type: Interventional
• Enrollment (Actual): 52
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Seoul National University Hospital
  • Korea
    • Seoul, Korea, Korea, Republic of
      • Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Composite of Pharmacokinetics	Cmax, AUClast, AUCinf, Tmax, t1/2, CL/F	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)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety&tolerability	Adverse events, Physical exam, Vital sign, laboratory(CBC,chemistry,U/A etc)	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)

Collaborators and Investigators

• Sponsor: Daewoong Pharmaceutical Co. LTD.

Study record dates

Study Major Dates

• Study Start: August 1, 2011
• Primary Completion (Actual): February 1, 2012
• Study Completion (Actual): February 1, 2012

Study Registration Dates

• First Submitted: August 24, 2011
• First Submitted That Met QC Criteria: August 25, 2011
• First Posted (Estimate): August 26, 2011

Study Record Updates

• Last Update Posted (Estimate): February 25, 2014
• Last Update Submitted That Met QC Criteria: February 23, 2014
• Last Verified: August 1, 2011

More Information

Terms related to this study

• Other Study ID Numbers: DWP10292