DWP05195 in Healthy Adult Male Volunteers

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

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: DWP05195

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Phase 1

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 45 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Allocation: RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: DOUBLE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: DWP05195	Drug: DWP05195; tablets, oral administration, single and multiple administrations

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Assessment of Safety & tolerability: Adverse events, vital signs, 12-Lead ECG, laboratory safety variables and physical examination	72hr after drug administration

Secondary Outcome Measures

Outcome Measure	Time Frame
Pharmacokinetics: Cmax, tmax, AUC, and t½ in plasma / amount of drug, fraction, and CLr in urine Pharmacodynamics: Thermal NeuroSensory Analyser	72 hr after drug administration

Collaborators and Investigators

• Sponsor: Daewoong Pharmaceutical Co. LTD.

Study record dates

Study Major Dates

• Study Start: April 1, 2009
• Primary Completion (ACTUAL): November 1, 2009

Study Registration Dates

• First Submitted: July 13, 2009
• First Submitted That Met QC Criteria: August 31, 2009
• First Posted (ESTIMATE): September 1, 2009

Study Record Updates

• Last Update Posted (ESTIMATE): April 1, 2010
• Last Update Submitted That Met QC Criteria: March 31, 2010
• Last Verified: August 1, 2009

More Information

Terms related to this study

• Other Study ID Numbers: DWP05195-P001