A Multiple Dose Study of DWP05195 in Healthy Adult Subjects

Daewoong Pharmaceutical

Status and phase: Completed; Phase 1

Conditions: Healthy Adult Volunteers

Treatments: Drug: DWP05195

Study type: Interventional

Funder types: Industry

Identifiers

NCT01094834

DWP05195-P002

Details and patient eligibility

About

The purpose of this study is to evaluate safety, tolerability, pharmacokinetics and pharmacodynamics of multiple administered DWP05195 in healthy volunteers

Enrollment: 40 estimated patients

Sex: Male

Ages: 20 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Healthy adult male subjects aged 20 to 45 years
2. 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.
3. A subject who provided written informed consent to participate in this study and cooperative with regard to compliance with study related constraints
4. 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

1. 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 2. A subject who had any allergic history to any drug (prescription drug or OTC medication etc.) 3. 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 4. A subject who had participated in any other clinical study within the last 12 weeks 5. A subject from whom over 400mL of blood was sampled(whole blood or plasma donation, etc.) within last 12 weeks 6. A Subject with the known evidence of the following infections or drug abuse
• HIV, HBs, HCV
• cannabinoid, opioid, amphetamine, cocaine, barbiturate, benzodiazepine 7. Smoker or smoking cessation within 1 month or ex-smoker with positive results by cotinine test 8. AST or ALT greater than 1.5 times the upper limit of reference range or QTc > 430 msec base on screening results 9. Blood pressure : SBP≥140mmHg, DBP≤85mmHg 10. A subject judged ineligible by the investigator to participate in this study for other reason containing clinical laboratory tests

Trial design

40 participants in 1 patient group

DWP05195

Experimental group

Treatment:

Drug: DWP05195