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

Healthy, Male Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03674060
• Other study ID #: SYO-1644
• Status: Completed
• Phase: Phase 1
• Start date: October 28, 2018
• Est. completion date: July 23, 2019

Study information

• Verified date: September 2018
• Source: Samyang Biopharmaceuticals Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: July 23, 2019
• Est. primary completion date: February 8, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 19 Years to 50 Years

Eligibility

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.)

Related Conditions & MeSH terms

• Healthy, Male

Intervention

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
• Nexavar tab
Nexavar 200mg/tablet, PO, 1 tablet

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Samyang Biopharmaceuticals Corporation	Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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