Healthy Adult VolunteersPhase 1NCT05162274
Clinical Trial to Assess Bioequivalence of Lazertinib Between Two Formulations in Healthy Volunteers.
A Phase 1 study testing Lazertinib(G001) and Lazertinib(G002) in people with Healthy Adult Volunteers, run by Yuhan Corporation at 1 site in South Korea.
Trial summary
This Clinical Trial is an open, randomized, fasted, single-dose, oral administration 2-sequence, 2-period crossover study to assess bioequivalence of lazertinib between two formulations in healthy adult volunteers. Read more about this study
- Who is it for?
- Ages 19 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Adult Volunteers
- What is being tested?
- Lazertinib(G001) and Lazertinib(G002)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteSouth Korea
- Study dates
- 30 Nov 2021to 14 Jan 2022
- 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 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male, over 19 years of age
- Male participants must agree to use an adequate contraception method from the first to the third month after the last dose.
- Participants must have a body mass index (BMI) between 18.5 and 30.0 kg/m2, inclusive(BMI = weight/height2), and body weight not less than 50 kg.
- Subjects without congenital or chronic diseases within the last 3 years and without pathologic symptoms as determined by medical diagnosis.
- Participants must be healthy on the basis of clinical laboratory tests performed at screening.
- Informed of the investigational nature of this study and voluntarily agree to participate in this study.
Who cannot join
- Clinically significant medical or psychiatric illness.
- Hypotension (SBP ≤ 90 mmHg or DBP ≤ 50 mmHg) or hypertension (SBP ≥ 150 mmHg or DBP ≥ 100 mmHg).
- A marked baseline prolongation of QTc.
- Within 14 days prior to the first administration of investigational product, use of prescription drugs or herbal medication, or within 7 days use of any over-the-counter medications
- Participants who are planning COVID-19 vaccine within 14 days before the first intake of study drug and to the end of the trials.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Hospital Clinical Trial Center
Seoul
About this study
Official title: An Open-label, Randomized, Fasted, Single-dose, Oral Administration, 2-sequence, 2-period Crossover Study to Assess Bioequivalence of Lazertinib Between Two Formulations in Healthy Adult Volunteers
This Clinical Trial is an open, randomized, fasted, single-dose, oral administration 2-sequence, 2-period crossover study to assess bioequivalence of lazertinib between two formulations in healthy adult volunteers. The subjects administer 240mg of lazertinib of different formulations on the fasted status on each period and have a wash-out period for 14-21 days between the first and second period.
Read the detailed description
This clinical trial will be conducted in healthy male volunteers at Seoul National University Hospital (SNUH) Clinical Trial Center.
It is expected to take approximately 32 days from the first dosing of Investigational Product until the final follow-up visit. Subjects will be hospitalized twice for 4 nights and 5 days with 7-14 days of wash-out period, and one visit will be needed for safety evaluation between 14-17 days from the last dosing of the Investigational Product.
- Conditions
- Healthy Adult Volunteers
- Being tested
- Lazertinib(G001), Lazertinib(G002)
- Keywords
- YH25448, Non-Small Cell Lung Cancer
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lazertinib(G001)Drug
Current formulation
Lazertinib(G002)Drug
New formulation
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Participants first received lazertinib(G001) 240mg tablet morning in a fasting state for 1 day. After a washout period of 14~21days, they then received lazertinib(G002) 240mg in a fasting state morning for 1 day. Receives: Drug: Lazertinib(G001); Drug: Lazertinib(G002) |
| Group 2 | Experimental | Participants first received lazertinib(G002) 240mg tablet morning in a fasting state for 1 day. After a washout period of 14~21days, they then received lazertinib(G001) 240mg in a fasting state morning for 1 day. Receives: Drug: Lazertinib(G001); Drug: Lazertinib(G002) |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUClast of YH25448
Area under the plasma concentration-time curve from zero to the time of the last quantitative concentration (AUC) of YH25448
Measured: 0 - 168 hours
Cmax of YH25448
Area under the plasma concentration-time curve from zero to the time of Maximum plasma concentration (Cmax) of YH25448
Measured: 0 - 168 hours
Secondary outcomes (7)
AUC0-72h of YH25448
Area under the plasma concentration-time curve from zero to the time of the last quantitative concentration (AUC) of YH25448
Measured: 0 - 72 hours
AUCinf of YH25448
Area under the plasma concentration time curve from zero to infinity (AUC) of YH25448
Measured: 0 - 168 hours
Tmax of YH25448
Time to reach Cmax of YH25448
Measured: 0 - 168 hours
t1/2 of YH25448
Terminal half life (t1/2) of YH25448
Measured: 0 - 168 hours
λz of YH25448
Terminal rate constant of YH25448
Measured: 0 - 168 hours
CL/F of YH25448
The apparent plasma clearance (CL/F) of YH25448
Measured: 0 - 168 hours
Vd/F of YH25448
Apparent Volume of distribution of YH25448
Measured: 0 - 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 Dec 2021
- Study start30 Nov 2021
- Primary completion14 Jan 2022
- Study completion14 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Adult VolunteersStudies of the same condition, open and under way.
- More trials run by Yuhan CorporationThe sponsor's other registered studies.
- 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
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yuhan Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Development and Medical Department, Study director, Yuhan Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05162274
- Sponsor's protocol ID
- YH25448-102
- Status last verified
- Feb 2022
- First submitted
- 6 Dec 2021
- Last updated
- 11 Dec 2024
- 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 11 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Randomized, Fasted, Single-dose, Oral Administration, 2-sequence, 2-period Crossover Study to Assess Bioequivalence of Lazertinib Between Two Formulations in Healthy Adult Volunteers
- ClinicalTrials.gov ID
- NCT05162274
- Acronym / sponsor ID
- YH25448-102
- Conditions
- Healthy Adult Volunteers
- Keywords
- YH25448, Non-Small Cell Lung Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Yuhan CorporationIndustry (pharma, biotech, devices)
- Study start
- 30 Nov 2021 (actual)
- Primary completion
- 14 Jan 2022 (actual)
- Study completion
- 14 Jan 2022 (actual)
- First posted
- 17 Dec 2021 (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.
This Clinical Trial is an open, randomized, fasted, single-dose, oral administration 2-sequence, 2-period crossover study to assess bioequivalence of lazertinib between two formulations in healthy adult volunteers. The subjects administer 240mg of lazertinib of different formulations on the fasted status on each period and have a wash-out period for 14-21 days between the first and second period.
Detailed description
This clinical trial will be conducted in healthy male volunteers at Seoul National University Hospital (SNUH) Clinical Trial Center.
It is expected to take approximately 32 days from the first dosing of Investigational Product until the final follow-up visit. Subjects will be hospitalized twice for 4 nights and 5 days with 7-14 days of wash-out period, and one visit will be needed for safety evaluation between 14-17 days from the last dosing of the Investigational Product.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Drug: Lazertinib(G001), Drug: Lazertinib(G002)Participants first received lazertinib(G001) 240mg tablet morning in a fasting state for 1 day. After a washout period of 14~21days, they then received lazertinib(G002) 240mg in a fasting state morning for 1 day. |
| Group 2 | Experimental | Drug: Lazertinib(G001), Drug: Lazertinib(G002)Participants first received lazertinib(G002) 240mg tablet morning in a fasting state for 1 day. After a washout period of 14~21days, they then received lazertinib(G001) 240mg in a fasting state morning for 1 day. |
Who may qualify
- Ages
- 19 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male, over 19 years of age
- Male participants must agree to use an adequate contraception method from the first to the third month after the last dose.
- Participants must have a body mass index (BMI) between 18.5 and 30.0 kg/m2, inclusive(BMI = weight/height2), and body weight not less than 50 kg.
- Subjects without congenital or chronic diseases within the last 3 years and without pathologic symptoms as determined by medical diagnosis.
- Participants must be healthy on the basis of clinical laboratory tests performed at screening.
Key exclusion criteria (5 listed)
- Clinically significant medical or psychiatric illness.
- Hypotension (SBP ≤ 90 mmHg or DBP ≤ 50 mmHg) or hypertension (SBP ≥ 150 mmHg or DBP ≥ 100 mmHg).
- A marked baseline prolongation of QTc.
- Within 14 days prior to the first administration of investigational product, use of prescription drugs or herbal medication, or within 7 days use of any over-the-counter medications
- Participants who are planning COVID-19 vaccine within 14 days before the first intake of study drug and to the end of the trials.
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 |
|---|---|---|
| Lazertinib(G001)Current formulation | Drug | Group 1, Group 2 |
| Lazertinib(G002)New formulation | Drug | Group 1, Group 2 |
Primary outcome
AUClast of YH25448
Time frame: 0 - 168 hours
Area under the plasma concentration-time curve from zero to the time of the last quantitative concentration (AUC) of YH25448
Cmax of YH25448
Time frame: 0 - 168 hours
Area under the plasma concentration-time curve from zero to the time of Maximum plasma concentration (Cmax) of YH25448
7 secondary outcomes
AUC0-72h of YH25448
Time frame: 0 - 72 hours
AUCinf of YH25448
Time frame: 0 - 168 hours
Tmax of YH25448
Time frame: 0 - 168 hours
t1/2 of YH25448
Time frame: 0 - 168 hours
λz of YH25448
Time frame: 0 - 168 hours
CL/F of YH25448
Time frame: 0 - 168 hours
Vd/F of YH25448
Time frame: 0 - 168 hours
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 11 Dec 2024.
- 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.
Clinical Development and Medical Department study director
Yuhan Corporation
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 Lazertinib(G001) and Lazertinib(G002) in people with Healthy Adult Volunteers, run by Yuhan 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 6 inclusion and 5 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 11 Dec 2024. 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?
AUClast of YH25448 (time frame: 0 - 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 11 Dec 2024.