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

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy, Male
• Intervention / Treatment: Drug: SYO-1644; Drug: Nexavar tab

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 Type: Interventional
• Enrollment (Actual): 32
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Samyang Biopharmaceuticals Corporation
• Collaborators: Seoul National University Hospital
• Investigators: Principal Investigator: Kyung-Sang Yu, MD, Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 28, 2018
• Primary Completion (Actual): February 8, 2019
• Study Completion (Actual): July 23, 2019

Study Registration Dates

• First Submitted: September 9, 2018
• First Submitted That Met QC Criteria: September 13, 2018
• First Posted (Actual): September 17, 2018

Study Record Updates

• Last Update Posted (Actual): August 30, 2019
• Last Update Submitted That Met QC Criteria: August 28, 2019
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Keywords: Healthy Male Volunteers; Evaluation of the Pharmacokinetic Property; A Dose-block Randomized, Active-controlled, Open-label
• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Protein Kinase Inhibitors; Sorafenib
• Other Study ID Numbers: SYO-1644

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No