DWP05195 in Healthy Adult Male Volunteers

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: DWP05195

• Registration Number: NCT00969787
• Lead Sponsor: Daewoong Pharmaceutical Co. LTD.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2009-04
• Study First Submitted: 2009-07-13
• Status Verified: 2009-08
• Study First Submitted QC: 2009-08-31
• Study First Posted: 2009-09-01
• Primary Completion: 2009-11
• Last Update Submitted: 2010-03-31
• Last Update Posted: 2010-04-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 80

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
DWP05195	DWP05195	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of