Non-Small Cell Lung CancerPhase 1NCT03556436
Clinical Trial to Evaluate the Safety and Effects of Ethnicity and Food on Pharmacokinetics of YH25448
A Phase 1 study testing YH25448 240mg in people with Non-Small Cell Lung Cancer, run by Yuhan Corporation at 1 site in South Korea.
Trial summary
Clinical trial is to evaluate the effect of ethnicity and food on the pharmacokinetics (how a drug is absorbed, metabolized, distributed and excreted; plasma drug concentration will be measured in this clinical trial) of YH25448, which Yuhan Corporation plans to develop as a therapeutic agent for Non-Small Cell Lung… Read more about this study
- Who is it for?
- Ages 19 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Non-Small Cell Lung Cancer
- What is being tested?
- YH25448 240mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteSouth Korea
- Study dates
- 3 Jul 2018to 30 Dec 2018
- 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 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Informed of the investigational nature of this study and voluntarily agree to participate in this study.
- Subjects with BMI range of ≥18.5 kg/m2 and < 30.0 kg/m2 and weighing ≥ 50 kg
- Subjects without congenital or chronic diseases within the last 3 years and without pathologic symptoms as determined by medical diagnosis
- Healthy Korean and Caucasian males who aged ≥ 19 and ≤ 55 years at the time of consent
Who cannot join
- Clinically significant chronic infection (e.g. AIDS) or 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 greater than 450 msec by Bazett's formula
- 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
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, Single-dose Phase 1 Clinical Trial to Evaluate the Safety and Effects of Ethnicity and Food on Pharmacokinetics of YH25448 in Healthy Korean and Caucasian Volunteers
Clinical trial is to evaluate the effect of ethnicity and food on the pharmacokinetics (how a drug is absorbed, metabolized, distributed and excreted; plasma drug concentration will be measured in this clinical trial) of YH25448, which Yuhan Corporation plans to develop as a therapeutic agent for Non-Small Cell Lung Cancer.
Read the detailed description
This clinical trial will be conducted in healthy Korean and Caucasian volunteers at Seoul National University Hospital (SNUH) Clinical Trial Center.
It is expected to take approximately 39 days from the first dosing of Investigational Product until the final follow-up visit. It will be hospitalized twice for 9 nights and 10 days with 21 days of interval, and one visit will be needed for safety evaluation between 14-17 days from the last dosing of the Investigational Product.
- Conditions
- Non-Small Cell Lung Cancer
- Being tested
- YH25448 240mg
- 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.
YH25448 240mgDrug
Also called YH25448
period 1: A single oral dose of YH25448 240 mg an overnight fast period 2: A single oral dose of YH25448 240 mg after a high-fat breakfast
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | YH25448 240mg single dose in korean Receives: Drug: YH25448 240mg |
| Group 2 | Experimental | YH25448 240mg single dose in caucasian Receives: Drug: YH25448 240mg |
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: 0-192 hrs
Cmax of YH25448
Area under the plasma concentration-time curve from zero to the time of Maximum plasma concentration (Cmax) of YH25448
Measured: 0-192 hrs
Secondary outcomes (5)
AUCinf of YH25448
Area under the plasma concentration time curve from zero to infinity (AUC) of YH25448
Measured: 0-192 hrs
Tmax of YH25448
Time to reach Cmax of YH25448
Measured: 0-192 hrs
t1/2 of YH25448
Terminal half life (t1/2) of YH25448
Measured: 0-192 hrs
CL/F of YH25448
The apparent plasma clearance (CL/F) of YH25448
Measured: 0-192 hrs
Vd/F of YH25448
Apparent Volume of distribution of YH25448
Measured: 0-192 hrs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2018
- Study start3 Jul 2018
- Primary completion30 Dec 2018
- Study completion30 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Small Cell Lung CancerStudies 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
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yuhan Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Seoul National University Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03556436
- Sponsor's protocol ID
- YH25448-101
- Status last verified
- Jan 2019
- First submitted
- 1 Jun 2018
- Last updated
- 16 Jan 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 16 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Single-dose Phase 1 Clinical Trial to Evaluate the Safety and Effects of Ethnicity and Food on Pharmacokinetics of YH25448 in Healthy Korean and Caucasian Volunteers
- ClinicalTrials.gov ID
- NCT03556436
- Acronym / sponsor ID
- YH25448-101
- Conditions
- Non-Small Cell Lung Cancer
- Keywords
- YH25448, Non-Small Cell Lung Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Yuhan CorporationIndustry (pharma, biotech, devices)
- Collaborators
- Seoul National University Hospital
- Study start
- 3 Jul 2018 (actual)
- Primary completion
- 30 Dec 2018 (actual)
- Study completion
- 30 Dec 2018 (actual)
- First posted
- 14 Jun 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.
Clinical trial is to evaluate the effect of ethnicity and food on the pharmacokinetics (how a drug is absorbed, metabolized, distributed and excreted; plasma drug concentration will be measured in this clinical trial) of YH25448, which Yuhan Corporation plans to develop as a therapeutic agent for Non-Small Cell Lung Cancer.
Detailed description
This clinical trial will be conducted in healthy Korean and Caucasian volunteers at Seoul National University Hospital (SNUH) Clinical Trial Center.
It is expected to take approximately 39 days from the first dosing of Investigational Product until the final follow-up visit. It will be hospitalized twice for 9 nights and 10 days with 21 days of interval, 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
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Drug: YH25448 240mgYH25448 240mg single dose in korean |
| Group 2 | Experimental | Drug: YH25448 240mgYH25448 240mg single dose in caucasian |
Who may qualify
- Ages
- 19 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Informed of the investigational nature of this study and voluntarily agree to participate in this study.
- Subjects with BMI range of ≥18.5 kg/m2 and < 30.0 kg/m2 and weighing ≥ 50 kg
- Subjects without congenital or chronic diseases within the last 3 years and without pathologic symptoms as determined by medical diagnosis
- Healthy Korean and Caucasian males who aged ≥ 19 and ≤ 55 years at the time of consent
Key exclusion criteria (4 listed)
- Clinically significant chronic infection (e.g. AIDS) or 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 greater than 450 msec by Bazett's formula
- 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
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 |
|---|---|---|
| YH25448 240mgAlso: YH25448period 1: A single oral dose of YH25448 240 mg an overnight fast period 2: A single oral dose of YH25448 240 mg after a high-fat breakfast | Drug | Group 1, Group 2 |
Primary outcome
AUClast of YH25448
Time frame: 0-192 hrs
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: 0-192 hrs
Area under the plasma concentration-time curve from zero to the time of Maximum plasma concentration (Cmax) of YH25448
5 secondary outcomes
AUCinf of YH25448
Time frame: 0-192 hrs
Tmax of YH25448
Time frame: 0-192 hrs
t1/2 of YH25448
Time frame: 0-192 hrs
CL/F of YH25448
Time frame: 0-192 hrs
Vd/F of YH25448
Time frame: 0-192 hrs
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 16 Jan 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.
The record lists no contact. Use the official record to reach the sponsor.
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 YH25448 240mg in people with Non-Small Cell Lung Cancer, 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 4 inclusion and 4 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 16 Jan 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?
AUClast of YH25448 (time frame: 0-192 hrs). 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 16 Jan 2019.