Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03674060
Recruitment Status : Completed
First Posted : September 17, 2018
Last Update Posted : August 30, 2019
Sponsor:
Collaborator:
Seoul National University Hospital
Information provided by (Responsible Party):
Samyang Biopharmaceuticals Corporation

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.

Condition or disease Intervention/treatment Phase
Healthy, Male Drug: SYO-1644 Drug: Nexavar tab Phase 1

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : October 28, 2018
Actual Primary Completion Date : February 8, 2019
Actual Study Completion Date : July 23, 2019

Resource links provided by the National Library of Medicine


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 Name: 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 Name: 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 Name: SYO-1644 100, 150, 200mg

Active Comparator: Nexavar
Nexavar 200mg/tablet, PO, 1 tablet
Drug: Nexavar tab
Nexavar 200mg/tablet, PO, 1 tablet
Other Name: Sorafenib 200mg




Primary Outcome Measures :
  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)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   19 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes
Criteria

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.)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03674060


Locations
Layout table for location information
Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Samyang Biopharmaceuticals Corporation
Seoul National University Hospital
Investigators
Layout table for investigator information
Principal Investigator: Kyung-Sang Yu, MD Seoul National University Hospital
Layout table for additonal information
Responsible Party: Samyang Biopharmaceuticals Corporation
ClinicalTrials.gov Identifier: NCT03674060    
Other Study ID Numbers: SYO-1644
First Posted: September 17, 2018    Key Record Dates
Last Update Posted: August 30, 2019
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Samyang Biopharmaceuticals Corporation:
Healthy Male Volunteers
Evaluation of the Pharmacokinetic Property
A Dose-block Randomized, Active-controlled, Open-label
Additional relevant MeSH terms:
Layout table for MeSH terms
Sorafenib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action