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Completed

NCT Number: NCT03674060

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.

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Key information

Conditions

Age range

19 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Seoul National University Hospital

Seoul, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy male age between 19 and 50 years old at the time of screening
  • 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
  • Agreement with written informed consent

Exclusion criteria

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

Treatment and study plan

SYO-1644

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

Other names: SYO-1644 100, 150, 200mg

Nexavar tab

Drug

Nexavar 200mg/tablet, PO, 1 tablet

Other names: Sorafenib 200mg

Primary outcomes

  1. Evaluation of pharmacokinetic properties

    Time frame: 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)

  2. Evaluation of pharmacokinetic properties

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Samyang Biopharmaceuticals Corporation

Industry

Collaborators

  • Seoul National University Hospital

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Sep 17, 2018
Registry last updated
Aug 30, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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