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

Phase 1

Completed

• Conditions: Healthy, Male
• Interventions: Drug: SYO-1644; Drug: Nexavar tab

• Registration Number: NCT03674060
• Lead Sponsor: Samyang Biopharmaceuticals Corporation

Brief Summary

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

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.

Study Timeline

• Status Verified: 2018-09
• Study First Submitted: 2018-09-09
• Study First Submitted QC: 2018-09-13
• Study First Posted: 2018-09-17
• Study Start: 2018-10-28
• Primary Completion: 2019-02-08
• Study Completion: 2019-07-23
• Last Update Submitted: 2019-08-28
• Last Update Posted: 2019-08-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 32

Inclusion Criteria

1. Healthy male age between 19 and 50 years old at the time of screening

2. 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

3. Agreement with written informed consent

Exclusion Criteria

1. Participants with clinically significant liver, kidney, nervous system, respiratory, endocrine, hematologic, cardiovascular, urinary, psychiatric disorders or history
2. 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)
3. Participants with hypersensitivity reactions or clinically significant hypersensitivity reactions to drugs including sorafenib and allogeneic drugs, and other drugs (aspirin, antibiotics, etc.)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SYO-1644 100mg	SYO-1644	SYO-1644 tablet, PO, 1 100mg tablet
SYO-1644 200mg	SYO-1644	SYO-1644 tablet, PO, 2 100mg tablet
Nexavar	Nexavar tab	Nexavar 200mg/tablet, PO, 1 tablet
SYO-1644 150mg	SYO-1644	SYO-1644 tablet, PO, 1 100mg tablet and 1 50mg tablet

Primary Outcome Measures

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

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of