DWP05195 in Healthy Adult Male Volunteers

NCT00969787 | Completed Phase 1 DMC

• 1 other identifier: DWP05195-P001
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Assessment of Safety & tolerability: Adverse events, vital signs, 12-Lead ECG, laboratory safety variables and physical examination

  72hr after drug administration

Secondary Outcomes (1)

• 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

Study Arms (1)

DWP05195

EXPERIMENTAL

Drug: DWP05195

Interventions

DWP05195 DRUG

tablets, oral administration, single and multiple administrations

DWP05195

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Daewoong Pharmaceutical Co. LTD.: lead

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

Location

Study Officials

• Kyung-Sang Yu

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: July 13, 2009
• First Posted: September 1, 2009
• Study Start: April 1, 2009
• Primary Completion: November 1, 2009
• Last Updated: April 1, 2010

Record last verified: 2009-08

Locations

KR (1)