Healthy, MalePhase 1NCT03208218
Crossover Study to Compare Pharmacokinetic Property of SYP-1512 Tab and Revlimid Cap in Healthy Male Volunteers
A Phase 1 study testing SYP-1512 and Revlimid cap in people with Healthy, Male, run by Samyang Biopharmaceuticals Corporation.
Trial summary
The purpose of this study is to evaluate the pharmacokinetics equivalence and safety by comparing pharmacokinetics characteristics between the SYP-1512 Tab and Revlimid cap (25mg) when administered a single-dose to healthy male volunteers. Read more about this study
- Who is it for?
- Ages 20 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy, Male
- What is being tested?
- SYP-1512 and Revlimid cap
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- No sites listed yet
- Study dates
- 17 Aug 2016to 31 Oct 2016
- 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 20 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Over 20aged in healthy males
- Those who do not have congenital or chronic diseases or pathological symptoms based on screening.
- The person who is determined to be the subject of the clinical laboratory test results such as hematology test, blood chemistry test, urine test, etc. set by the person in charge of the examination of the medical institution
- BMI : 18-30
- Those who have not donated blood within 2 weeks
- Those without a history of gastrointestinal resection
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- Those who have no history of mental illness within the last 5 years
- Agreement with written informed consent
- Anyone who can follow and follow all scheduled admission and outpatient visits, dosing, clinical laboratory testing and subject compliance
- If the partner is a woman of childbearing age who does not use the appropriate method of contraception (even if the man has undergone a vasectomy), while taking lenalidomide, during the interruption, for consenting to use condoms for 28 days after the last dose
- In the vital sign measured in a sitting position, the systolic blood pressure ≤145 mmHg and ≥100 mmHg, the diastolic blood pressure ≤95 mmHg and ≥60 mmHg, the pulse rate> 40 and <100 times / minute
- Electrocardiogram (ECG) of the 12-electrode, QTc ≤ 450 msec
- Those who have agreed not to donate blood or plasma and semen for at least 28 days after taking this drug
- If the contraceptive is withdrawn due to contraception or partner's pregnancy confirmation during testing. Those who agree to respond to follow-up within 6 months after pregnancy and after delivery
Who cannot join
- Those taking drugs that significantly induce drug metabolizing enzymes within one month before screening (eg, barbiturate) or inhibit
- Those taking medication that could affect the test within 10 days before screening
- The person who is in charge of the examination of the medical institution (or the examining doctor who is delegated)
- Those who have participated in the bioequivalence test or other clinical studies within 3 months prior to the administration of the test and administered the clinical trial drug
- Persons with hypersensitivity to venous puncture
- Screening Within the first 6 months, a person with a history of regular alcohol consumption as follows: 1 cup = 150 mL of wine or 360 mL of beer or 45 mL of distillate)
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- Patients with severe hepatic impairment
- Patients who are hypersensitive to NSAIDs and other components of NSAID
- Patients with genetic problems such as galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption.
- Patients with renal impairment (Cockcroft-Gault-type creatinine clearance <50 mL / min)
- Positive result of Serum test [RPR Ab (VDRL), HBsAg, HCV Ab, anti HIV (AIDS)]
About this study
Official title: An Open-label, Randomized, Single Dose, Crossover Bioequivalent Study to Compare Pharmacokinetic Property of SYP-1512 Tab and Revlimid Cap, 25mg in Healthy Male Volunteers
The purpose of this study is to evaluate the pharmacokinetics equivalence and safety by comparing pharmacokinetics characteristics between the SYP-1512 Tab and Revlimid cap (25mg) when administered a single-dose to healthy male volunteers.
Read the detailed description
Healthy volunteers are administrated single-dose over the period I and II (crossover) of SYP-1512 Tab and Revlimid cap (25mg) as of lenalidomide 25mg.
Every time before and after each medication, pharmacokinetic (PK) parameters and safety of SYP-1512 Tab and Revlimid cap (25mg) is performed using a blood sample and conducting some tests (vital signs, physical exam, ECG, laboratory test, etc.) respectively
- Conditions
- Healthy, Male
- Being tested
- SYP-1512, Revlimid cap
- Keywords
- Evaluation of the pharmacokinetics equivalence, Healthy volunteers, Single dose over the period I and II(crossover), Healthy male volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SYP-1512Drug
Also called Lenalidomide 25mg
Lenalidomide 25mg/tablet, PO, 1 tablet once daily for I\&II D1(crossover)
Revlimid capDrug
Also called Lenalidomide 25mg
Lenalidomide 25mg/capsule, po, 1 capsule once daily for period I\&II D1(crossover)
| Study group | Role | What they receive |
|---|---|---|
| SYP-1512 | Experimental | Lenalidomide 25mg/tablet, PO, 1 tablet once daily for I\&II D1(crossover) Receives: Drug: SYP-1512 |
| Revlimid cap. | Active comparator | Lenalidomide 25mg/capsule, po, 1 capsule once daily for period I\&II D1(crossover) Receives: Drug: Revlimid cap |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics of the AUCt between SYP-1512 and Revlimid cap(25mg)
Bioequivalance of the AUCt between SYP-1512 and Revlimid cap(25mg)
Measured: 0-24hours
Pharmacokinetics of the Cmax between SYP-1512 and Revlimid cap(25mg)
Bioequivalance of the Cmax between SYP-1512 and Revlimid cap(25mg)
Measured: 0-24hours
Secondary outcomes (3)
Pharmacokinetics of the AUCinf SYP-1512 and Revlimid cap (25mg)
Bioequivalance of the AUCinf SYP-1512 and Revlimid cap (25mg)
Measured: 0-inf
Pharmacokinetics of the Tmax of SYP-1512 and Revlimid cap (25mg)
Bioequivalance of the Tmax of SYP-1512 and Revlimid cap (25mg)
Measured: 0-24hours
Pharmacokinetics of the T1/2 of SYP-1512 and Revlimid cap (25mg)
Bioequivalance of the T1/2 of SYP-1512 and Revlimid cap (25mg)
Measured: 0-24hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2017
- Study start17 Aug 2016
- Primary completion25 Aug 2016
- Study completion31 Oct 2016
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
- Crossover
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samyang Biopharmaceuticals Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Chungnam National University Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03208218
- Sponsor's protocol ID
- BIBE2016-02
- Status last verified
- Jul 2017
- First submitted
- 25 Jun 2017
- Last updated
- 6 Jul 2017
- 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 6 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Randomized, Single Dose, Crossover Bioequivalent Study to Compare Pharmacokinetic Property of SYP-1512 Tab and Revlimid Cap, 25mg in Healthy Male Volunteers
- ClinicalTrials.gov ID
- NCT03208218
- Acronym / sponsor ID
- BIBE2016-02
- Conditions
- Healthy, Male
- Keywords
- Evaluation of the pharmacokinetics equivalence, Healthy volunteers, Single dose over the period I and II(crossover), Healthy male volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Samyang Biopharmaceuticals CorporationIndustry (pharma, biotech, devices)
- Collaborators
- Chungnam National University Hospital
- Study start
- 17 Aug 2016 (actual)
- Primary completion
- 25 Aug 2016 (actual)
- Study completion
- 31 Oct 2016 (actual)
- First posted
- 5 Jul 2017 (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 equivalence and safety by comparing pharmacokinetics characteristics between the SYP-1512 Tab and Revlimid cap (25mg) when administered a single-dose to healthy male volunteers.
Detailed description
Healthy volunteers are administrated single-dose over the period I and II (crossover) of SYP-1512 Tab and Revlimid cap (25mg) as of lenalidomide 25mg.
Every time before and after each medication, pharmacokinetic (PK) parameters and safety of SYP-1512 Tab and Revlimid cap (25mg) is performed using a blood sample and conducting some tests (vital signs, physical exam, ECG, laboratory test, etc.) respectively
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SYP-1512 | Experimental | Drug: SYP-1512Lenalidomide 25mg/tablet, PO, 1 tablet once daily for I\&II D1(crossover) |
| Revlimid cap. | Active comparator | Drug: Revlimid capLenalidomide 25mg/capsule, po, 1 capsule once daily for period I\&II D1(crossover) |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- Over 20aged in healthy males
- Those who do not have congenital or chronic diseases or pathological symptoms based on screening.
- The person who is determined to be the subject of the clinical laboratory test results such as hematology test, blood chemistry test, urine test, etc. set by the person in charge of the examination of the medical institution
- BMI : 18-30
- Those who have not donated blood within 2 weeks
Key exclusion criteria (11 listed)
- Those taking drugs that significantly induce drug metabolizing enzymes within one month before screening (eg, barbiturate) or inhibit
- Those taking medication that could affect the test within 10 days before screening
- The person who is in charge of the examination of the medical institution (or the examining doctor who is delegated)
- Those who have participated in the bioequivalence test or other clinical studies within 3 months prior to the administration of the test and administered the clinical trial drug
- Persons with hypersensitivity to venous puncture
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 |
|---|---|---|
| SYP-1512Also: Lenalidomide 25mgLenalidomide 25mg/tablet, PO, 1 tablet once daily for I\&II D1(crossover) | Drug | SYP-1512 |
| Revlimid capAlso: Lenalidomide 25mgLenalidomide 25mg/capsule, po, 1 capsule once daily for period I\&II D1(crossover) | Drug | Revlimid cap. |
Primary outcome
Pharmacokinetics of the AUCt between SYP-1512 and Revlimid cap(25mg)
Time frame: 0-24hours
Bioequivalance of the AUCt between SYP-1512 and Revlimid cap(25mg)
Pharmacokinetics of the Cmax between SYP-1512 and Revlimid cap(25mg)
Time frame: 0-24hours
Bioequivalance of the Cmax between SYP-1512 and Revlimid cap(25mg)
3 secondary outcomes
Pharmacokinetics of the AUCinf SYP-1512 and Revlimid cap (25mg)
Time frame: 0-inf
Pharmacokinetics of the Tmax of SYP-1512 and Revlimid cap (25mg)
Time frame: 0-24hours
Pharmacokinetics of the T1/2 of SYP-1512 and Revlimid cap (25mg)
Time frame: 0-24hours
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 6 Jul 2017.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SYP-1512 and Revlimid cap in people with Healthy, Male, run by Samyang Biopharmaceuticals Corporation.
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 14 inclusion and 11 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 6 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Pharmacokinetics of the AUCt between SYP-1512 and Revlimid cap(25mg) (time frame: 0-24hours). 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 6 Jul 2017.