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

NCT03674060 | Completed Phase 1

• 1 other identifier: SYO-1644
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy, Male

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (4)

SYO-1644 100mg

EXPERIMENTAL

SYO-1644 tablet, PO, 1 100mg tablet

Drug: SYO-1644

SYO-1644 150mg

EXPERIMENTAL

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

Drug: SYO-1644

SYO-1644 200mg

EXPERIMENTAL

SYO-1644 tablet, PO, 2 100mg tablet

Drug: SYO-1644

Nexavar

ACTIVE COMPARATOR

Nexavar 200mg/tablet, PO, 1 tablet

Drug: Nexavar tab

Interventions

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

Also known as: SYO-1644 100, 150, 200mg

SYO-1644 100mg; SYO-1644 150mg; SYO-1644 200mg

Nexavar tab DRUG

Nexavar 200mg/tablet, PO, 1 tablet

Also known as: Sorafenib 200mg

Nexavar

Eligibility Criteria

• Age: 19 Years - 50 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.)

Sponsors & Collaborators

• Samyang Biopharmaceuticals Corporation: lead
• Seoul National University Hospital: collaborator

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

Location

MeSH Terms

Interventions

Sorafenib

Intervention Hierarchy (Ancestors)

Phenylurea Compounds; Urea; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Niacinamide; Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Study Officials

• Kyung-Sang Yu, MD

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2018
• First Posted: September 17, 2018
• Study Start: October 28, 2018
• Primary Completion: February 8, 2019
• Study Completion: July 23, 2019
• Last Updated: August 30, 2019

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)