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

NCT ID: NCT03674060

Last Updated: 2019-08-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-28

Study Completion Date

2019-07-23

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.

Conditions

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Healthy, Male

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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SYO-1644 100mg

SYO-1644 tablet, PO, 1 100mg tablet

Group Type EXPERIMENTAL

SYO-1644

Intervention Type DRUG

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

SYO-1644 150mg

SYO-1644 tablet, PO, 1 100mg tablet and 1 50mg tablet

Group Type EXPERIMENTAL

SYO-1644

Intervention Type DRUG

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

SYO-1644 200mg

SYO-1644 tablet, PO, 2 100mg tablet

Group Type EXPERIMENTAL

SYO-1644

Intervention Type DRUG

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

Nexavar 200mg/tablet, PO, 1 tablet

Group Type ACTIVE_COMPARATOR

Nexavar tab

Intervention Type DRUG

Nexavar 200mg/tablet, PO, 1 tablet

Interventions

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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

Intervention Type DRUG

Nexavar tab

Nexavar 200mg/tablet, PO, 1 tablet

Intervention Type DRUG

Other Intervention Names

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SYO-1644 100, 150, 200mg Sorafenib 200mg

Eligibility Criteria

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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.)
Minimum Eligible Age

19 Years

Maximum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role collaborator

Samyang Biopharmaceuticals Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kyung-Sang Yu, MD

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Locations

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Seoul National University Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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SYO-1644

Identifier Type: -

Identifier Source: org_study_id