Study to Compare Pharmacokinetic Property of SYO-1644 Tab. and Nexavar Tab. in Healthy Male Volunteers

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the pharmacokinetics characteristics ,tolerability, and safety after orally administrating SYO-1644 to healthy male volunteers in randomized, active-controlled, open-label clinical study.

Detailed Description
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After orally administrating SYO-1644 and Nexavar 200 mg to healthy male participants , the safety, tolerability, and pharmacokinetic characteristics are to be compared while testing pharmacokinetic characteristics based on the dosage.

Official Title
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A Dose-block Randomized, Active-controlled, Open-label Clinical Study to Compare Pharmacokinetic Property of SYO-1644 Tab and Nexavar Tab in Healthy Male Volunteers

Conditions
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Healthy, Male

Intervention / Treatment
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* Drug: SYO-1644
* Drug: Nexavar tab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy male age between 19 and 50 years old at the time of screening Healthy male more than or equal to 50 kg or less than or equal to 90 kg with BMI of 18 27 BMI(kg/m2) = Weight(kg) / {Height(m)}2 Agreement with written informed consent Exclusion Criteria: Participants with clinically significant liver, kidney, nervous system, respiratory, endocrine, hematologic, cardiovascular, urinary, psychiatric disorders or history Participants with history of gastrointestinal ulcers, gastritis, gastric ulcer, gastroesophageal reflux disease, Crohn's disease, etc, that may affect the safety and pharmacokinetic evaluation of the test drug, except simple appendectomy and hernia surgery) Participants with hypersensitivity reactions or clinically significant hypersensitivity reactions to drugs including sorafenib and allogeneic drugs, and other drugs (aspirin, antibiotics, etc.)

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SYO-1644 100mg<br>SYO-1644 tablet, PO, 1 100mg tablet | Drug: SYO-1644<br>* 100mg: SYO-1644 tablet, PO, 1 100mg tablet 150mg: SYO-1644 tablet, PO, 1 100mg tablet and 1 50mg tablet 200mg: SYO-1644 tablet, PO, 2 100mg tablet<br>* Other names: SYO-1644 100, 150, 200mg;|
| Experimental: SYO-1644 150mg<br>SYO-1644 tablet, PO, 1 100mg tablet and 1 50mg tablet | Drug: SYO-1644<br>* 100mg: SYO-1644 tablet, PO, 1 100mg tablet 150mg: SYO-1644 tablet, PO, 1 100mg tablet and 1 50mg tablet 200mg: SYO-1644 tablet, PO, 2 100mg tablet<br>* Other names: SYO-1644 100, 150, 200mg;|
| Experimental: SYO-1644 200mg<br>SYO-1644 tablet, PO, 2 100mg tablet | Drug: SYO-1644<br>* 100mg: SYO-1644 tablet, PO, 1 100mg tablet 150mg: SYO-1644 tablet, PO, 1 100mg tablet and 1 50mg tablet 200mg: SYO-1644 tablet, PO, 2 100mg tablet<br>* Other names: SYO-1644 100, 150, 200mg;|
| Active Comparator: Nexavar<br>Nexavar 200mg/tablet, PO, 1 tablet | Drug: Nexavar tab<br>* Nexavar 200mg/tablet, PO, 1 tablet<br>* Other names: Sorafenib 200mg;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of pharmacokinetic properties | Pharmacokinetics of the AUCt between SYO-1644 and Nexavar cap(200mg) | 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 168 hours | 
| Evaluation of pharmacokinetic properties | Pharmacokinetics of the Cmax between SYO-1644 and Nexavar cap(200mg) | 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 168 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Healthy Male Volunteers, Evaluation of the Pharmacokinetic Property, A Dose-block Randomized, Active-controlled, Open-label