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Completed

NCT Number: NCT01423526

A Single Dose Study of DWP10292 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.

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Key information

Conditions

Age range

20 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Seoul National University Hospital, Seoul, Korea, South Korea

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

DWP10292

Drug

Drug: DWP10292 tablets, oral administration, single administration

Placebo

Drug

Placebo tablets, oral administration, single administrations

Primary outcomes

  1. 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)

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

Secondary outcomes

  1. 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)

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

Sponsors and collaborators

Lead sponsor

Daewoong Pharmaceutical Co. LTD.

Industry

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Aug 26, 2011
Registry last updated
Feb 25, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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