Healthy, MalePhase 1NCT03674060
Study to Compare Pharmacokinetic Property of SYO-1644 Tab. and Nexavar Tab. in Healthy Male Volunteers
A Phase 1 study testing SYO-1644 and Nexavar tab in people with Healthy, Male, run by Samyang Biopharmaceuticals Corporation at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy, Male
- What is being tested?
- SYO-1644 and Nexavar tab
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteSouth Korea
- Study dates
- 28 Oct 2018to 23 Jul 2019
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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.)
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Healthy, Male
- Being tested
- SYO-1644, Nexavar tab
- Keywords
- Healthy Male Volunteers, Evaluation of the Pharmacokinetic Property, A Dose-block Randomized, Active-controlled, Open-label
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SYO-1644Drug
Also called SYO-1644 100, 150, 200mg
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 tabDrug
Also called Sorafenib 200mg
Nexavar 200mg/tablet, PO, 1 tablet
| Study group | Role | What they receive |
|---|---|---|
| SYO-1644 100mg | Experimental | SYO-1644 tablet, PO, 1 100mg tablet Receives: Drug: SYO-1644 |
| SYO-1644 150mg | Experimental | SYO-1644 tablet, PO, 1 100mg tablet and 1 50mg tablet Receives: Drug: SYO-1644 |
| SYO-1644 200mg | Experimental | SYO-1644 tablet, PO, 2 100mg tablet Receives: Drug: SYO-1644 |
| Nexavar | Active comparator | Nexavar 200mg/tablet, PO, 1 tablet Receives: Drug: Nexavar tab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of pharmacokinetic properties
Pharmacokinetics of the AUCt between SYO-1644 and Nexavar cap(200mg)
Measured: 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)
Measured: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 168 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2018
- Study start28 Oct 2018
- Primary completion8 Feb 2019
- Study completion23 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy, MaleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samyang Biopharmaceuticals Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Seoul National University Hospital
- Responsible party
- Sponsor
- Investigators
- Kyung-Sang Yu, MD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03674060
- Sponsor's protocol ID
- SYO-1644
- Status last verified
- Sep 2018
- First submitted
- 9 Sep 2018
- Last updated
- 30 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03674060
- Acronym / sponsor ID
- SYO-1644
- Conditions
- Healthy, Male
- Keywords
- Healthy Male Volunteers, Evaluation of the Pharmacokinetic Property, A Dose-block Randomized, Active-controlled, Open-label
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Samyang Biopharmaceuticals CorporationIndustry (pharma, biotech, devices)
- Collaborators
- Seoul National University Hospital
- Study start
- 28 Oct 2018 (actual)
- Primary completion
- 8 Feb 2019 (actual)
- Study completion
- 23 Jul 2019 (actual)
- First posted
- 17 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| SYO-1644 100mg | Experimental | Drug: SYO-1644SYO-1644 tablet, PO, 1 100mg tablet |
| SYO-1644 150mg | Experimental | Drug: SYO-1644SYO-1644 tablet, PO, 1 100mg tablet and 1 50mg tablet |
| SYO-1644 200mg | Experimental | Drug: SYO-1644SYO-1644 tablet, PO, 2 100mg tablet |
| Nexavar | Active comparator | Drug: Nexavar tabNexavar 200mg/tablet, PO, 1 tablet |
Who may qualify
- Ages
- 19 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
- Agreement with written informed consent
Key exclusion criteria (3 listed)
- 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.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SYO-1644Also: SYO-1644 100, 150, 200mg100mg: 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 | Drug | SYO-1644 100mg, SYO-1644 150mg, SYO-1644 200mg |
| Nexavar tabAlso: Sorafenib 200mgNexavar 200mg/tablet, PO, 1 tablet | Drug | Nexavar |
Primary outcome
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)
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kyung-Sang Yu, MD principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SYO-1644 and Nexavar tab in people with Healthy, Male, run by Samyang Biopharmaceuticals Corporation at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2019.