A Multiple Dose Study of DWP05195 in Healthy Adult Subjects

Healthy Adult Volunteers Clinical Trial

Official title:

A Multiple Dose Study To Determine Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of DWP05195 in Healthy Adult Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01094834
• Other study ID #: DWP05195-P002
• Status: Completed
• Phase: Phase 1
• First received: March 26, 2010
• Last updated: February 8, 2011
• Start date: April 2010

Study information

• Verified date: February 2011
• Source: Daewoong Pharmaceutical Co. LTD.
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. primary completion date: October 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 45 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator)

Related Conditions & MeSH terms

• Healthy Adult Volunteers

Intervention

Drug:
• DWP05195
tablets, oral administration, multiple administration

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Daewoong Pharmaceutical Co. LTD.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of safety & tolerability: adverse events, vital signs, 12-Lead ECG, laboratory safety variables and physical examination		17 days after drug administration	No