Clinical trial NCT00969787: DWP05195 in Healthy Adult Male Volunteers
Official title: DWP05195 in Healthy Adult Male Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Daewoong Pharmaceutical Co. LTD.
Sponsor class: INDUSTRY
First posted: 2009-09-01
Enrollment: 80
Sex: MALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP

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


Eligibility criteria: 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

Primary outcomes:
measure: Assessment of Safety & tolerability: Adverse events, vital signs, 12-Lead ECG, laboratory safety variables and physical examination
timeFrame: 72hr after drug administration
Secondary outcomes:
measure: Pharmacokinetics: Cmax, tmax, AUC, and t½ in plasma / amount of drug, fraction, and CLr in urine Pharmacodynamics: Thermal NeuroSensory Analyser
timeFrame: 72 hr after drug administration
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Kyung-Sang Yu
role: PRINCIPAL_INVESTIGATOR
References: