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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03674060

Enrollment

Registered

2018-09-17

Start date

2018-10-28

Completion date

2019-07-23

Last updated

2019-08-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy, Male

Keywords

Healthy Male Volunteers, Evaluation of the Pharmacokinetic Property, A Dose-block Randomized, Active-controlled, Open-label

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.

Interventions

DRUGSYO-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

DRUGNexavar tab

Nexavar 200mg/tablet, PO, 1 tablet

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

19 Years to 50 Years

Healthy volunteers

Yes

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.)

Design outcomes

Primary

Measure	Time frame	Description
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 AUCt between SYO-1644 and Nexavar cap(200mg)

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026