DWP05195 in Healthy Adult Male Volunteers

This study has been completed.
Sponsor:
Information provided by:
Daewoong Pharmaceutical Co. LTD.
ClinicalTrials.gov Identifier:
NCT00969787
First received: July 13, 2009
Last updated: March 31, 2010
Last verified: August 2009
  Purpose

The purpose of this study is to evaluate safety, tolerability, pharmacokinetics and pharmacodynamics of orally administrated DWP05195 in healthy male volunteers.


Condition Intervention Phase
Healthy
Drug: DWP05195
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Official Title: DWP05195 in Healthy Adult Male Volunteers

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

Primary Outcome Measures:
  • Assessment of Safety & tolerability: Adverse events, vital signs, 12-Lead ECG, laboratory safety variables and physical examination [ Time Frame: 72hr after drug administration ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Pharmacokinetics: Cmax, tmax, AUC, and t½ in plasma / amount of drug, fraction, and CLr in urine Pharmacodynamics: Thermal NeuroSensory Analyser [ Time Frame: 72 hr after drug administration ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: April 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: DWP05195 Drug: DWP05195
tablets, oral administration, single and multiple administrations

  Eligibility

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

Inclusion Criteria:

  • Healthy adult male subjects aged 20 to 45 years
  • The subject has a Body weight ≥ 50 kg and < 90 kg and Body Mass Index (BMI) ≥ 19.0 kg/m2 and < 27.0 kg/m2
  • A subject who provided written informed consent to participate in this study and cooperative with regard to compliance with study related constraints
  • 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 respiratory, cardiovascular, endocrinology, liver, kidney, gastrointestinal, hematology, neurology and psychology function or other significant diseases and history or suspicion of current drug abuse and alcohol abuse
  • A subject who had any allergic history to any drug (prescription drug or OTC medication etc.)
  • A subject who had received treatment with below listed drug within specified period prior to the first dose of study medication

    • Within last 1 month: drug or food known CYP1A2 inducer or inhibitor
    • Within 2 weeks: Prescribed or herbal or Non-prescribed medicine
    • Within 3 days: Consumption of grapefruit juice/grapefruit containing products or orange juice/orange containing products, garlic extracted functional foods
    • Within 3 days: Consumption of alcohol or caffeine
  • A subject who had participated in any other clinical study within the last 12 weeks
  • A subject from whom over 400mL of blood was sampled(whole blood or plasma donation, etc.) within last 12 weeks
  • A Subject with the known evidence of the following infections or drug abuse
  • HIV, HBs, HCV
  • cannabinoid, opioid, amphetamine, cocaine, barbiturate, benzodiazepine
  • Smoker or smoking cessation within 1 month or ex-smoker with positive results by cotinine test
  • AST or ALT greater than 1.5 times the upper limit of reference range or QTc > 430 msec base on screening results
  • Blood pressure: SBP ≥ 140 mmHg, DBP ≤ 85 mmHg
  • A subject judged ineligible by the investigator to participate in this study for other reason containing clinical laboratory tests
  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: NCT00969787

Locations
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., Daewoong Pharmaceutical Co. LTD
ClinicalTrials.gov Identifier: NCT00969787     History of Changes
Other Study ID Numbers: DWP05195-P001
Study First Received: July 13, 2009
Last Updated: March 31, 2010
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

ClinicalTrials.gov processed this record on October 21, 2014