Hepatic ImpairmentPhase 1NCT05112952
A Study to Evaluate the Effect of Hepatic Impairment on Lazertinib (JNJ-73841937)
A Phase 1 study testing Lazertinib in people with Hepatic Impairment and Healthy, run by Janssen Research & Development, LLC at 2 sites in Germany.
Trial summary
The purpose of this study is to evaluate the pharmacokinetics (PK) of a single oral dose of lazertinib in participants with impaired hepatic function when compared with healthy participants with normal hepatic function, under fed conditions. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Hepatic Impairment, Healthy
- What is being tested?
- Lazertinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 2 sitesGermany
- Study dates
- 30 Nov 2021to 11 Jul 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 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All Participants:
- Must have a clinically stable hepatic function as confirmed by the serum bilirubin and transaminase levels measured during screening and those measured on Day -1
- Willing and able to adhere to the prohibitions and restrictions specified in this protocol
- If a woman, must not be of childbearing potential: postmenopausal (amenorrhea for at least 12 months and a serum follicle stimulating hormone within postmenopausal range); or surgically sterile (hysterectomy, bilateral salpingectomy, bilateral oophorectomy, bilateral tubal occlusion/ligation procedure)
- Healthy Participants with normal hepatic function:
- Blood pressure (after the participant is supine for 5 minutes) between 90 and 140 millimeter of mercury (mmHg) systolic for participants less than or equal to (<=) 60 years old and between 90 and 150 mmHg for participants greater than (>) 60 years old, inclusive, and no higher than 90 mmHg diastolic. If blood pressure is out of range, up to 2 repeated assessments are permitted per visit
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- Pharmacogenomics: Healthy participants must have matching glutathione S-transferase Mu 1 (GSTM1) genotype (null or non-null GSTM1 genotype) to individual hepatic impairment group participants
- Participants with hepatic impairment:
- A 12-lead electrocardiogram (ECG) consistent with adequate cardiac conduction and function as per judgement by the investigator, including: a) Sinus rhythm; b) Heart rate between 50 and 100 beats per minute (extremes included); c) QTc interval <= 480 milliseconds (ms) (corrected cf. Fridericia; QTcF)
- Concomitant medications to treat underlying disease states or medical conditions related to hepatic impairment are allowed. Participants must be on a stable dose of medication and/or treatment regimen for at least 2 weeks before dosing as well as during the study
Who cannot join
- All Participants:
- Participant has known allergies, hypersensitivity, or intolerance to Lazertinib or its excipients
- Any surgical or medical condition that may alter the absorption, metabolism, or excretion of the study drug (example, gastrectomy, Crohn's disease etc.), with the exception of hepatic impairment
- Active gall bladder or biliary tract disease (example, acute cholecystitis, symptomatic cholelithiasis)
- Participant tests positive for human immunodeficiency virus (HIV)-1 or HIV-2 at screening
- Participant has a lack of adequate venous access
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
CRS Clinical Research Services Kiel GmbH
Kiel, 24105
APEX GmbH
München, 81241
About this study
Official title: A Single-Dose, Open-Label, Parallel-Group, Multi-Center Study to Evaluate the Effect of Hepatic Impairment on the Pharmacokinetics of Lazertinib (JNJ-73841937)
The purpose of this study is to evaluate the pharmacokinetics (PK) of a single oral dose of lazertinib in participants with impaired hepatic function when compared with healthy participants with normal hepatic function, under fed conditions.
- Conditions
- Hepatic Impairment, Healthy
- Being tested
- Lazertinib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LazertinibDrug
Also called JNJ-73841937,, YH25448
Lazertinib tablet will be administered orally.
| Study group | Role | What they receive |
|---|---|---|
| Part A: Group 1: Moderate Hepatic Impairment | Experimental | Participants with moderate hepatic impairment will receive a single oral dose of lazertinib. Receives: Drug: Lazertinib |
| Part A: Group 2: Normal Hepatic Function | Active comparator | Participants with normal hepatic function who qualify for the control group will receive a single oral dose of lazertinib. Receives: Drug: Lazertinib |
| Part B: Group 3 (Optional): Mild Hepatic Impairment | Experimental | Participants with mild hepatic impairment will receive a single oral dose of lazertinib. Receives: Drug: Lazertinib |
| Part B: Group 4 (Optional): Severe Hepatic Impairment | Experimental | Participants with severe hepatic impairment will receive a single oral dose of lazertinib. Receives: Drug: Lazertinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma Concentrations of Lazertinib
Plasma concentrations of lazertinib will be analyzed using a validated, specific, and sensitive method to assess the effect of hepatic impairment on the pharmacokinetic of lazertinib.
Measured: Predose up to 312 hour postdose (up to Day 14)
Secondary outcomes (1)
Percentage of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability
AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non investigational) product. An AE does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.
Measured: Up to 49 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2021
- Study start30 Nov 2021
- Primary completion11 Jul 2022
- Study completion11 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatic ImpairmentStudies of the same condition, open and under way.
- More trials run by Janssen Research & Development, LLCThe 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Research & Development, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Research & Development, LLC Clinical Trial, Study director, Janssen Research & Development, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05112952
- Sponsor's protocol ID
- CR109022
- Other IDs
- 2021-001950-71, 73841937NSC1007
- Status last verified
- Apr 2025
- First submitted
- 2 Nov 2021
- Last updated
- 27 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Dose, Open-Label, Parallel-Group, Multi-Center Study to Evaluate the Effect of Hepatic Impairment on the Pharmacokinetics of Lazertinib (JNJ-73841937)
- ClinicalTrials.gov ID
- NCT05112952
- Acronym / sponsor ID
- CR109022
- Conditions
- Hepatic Impairment, Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
- Study start
- 30 Nov 2021 (actual)
- Primary completion
- 11 Jul 2022 (actual)
- Study completion
- 11 Jul 2022 (actual)
- First posted
- 9 Nov 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.
The purpose of this study is to evaluate the pharmacokinetics (PK) of a single oral dose of lazertinib in participants with impaired hepatic function when compared with healthy participants with normal hepatic function, under fed conditions.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Part A: Group 1: Moderate Hepatic Impairment | Experimental | Drug: LazertinibParticipants with moderate hepatic impairment will receive a single oral dose of lazertinib. |
| Part A: Group 2: Normal Hepatic Function | Active comparator | Drug: LazertinibParticipants with normal hepatic function who qualify for the control group will receive a single oral dose of lazertinib. |
| Part B: Group 3 (Optional): Mild Hepatic Impairment | Experimental | Drug: LazertinibParticipants with mild hepatic impairment will receive a single oral dose of lazertinib. |
| Part B: Group 4 (Optional): Severe Hepatic Impairment | Experimental | Drug: LazertinibParticipants with severe hepatic impairment will receive a single oral dose of lazertinib. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Must have a clinically stable hepatic function as confirmed by the serum bilirubin and transaminase levels measured during screening and those measured on Day -1
- Willing and able to adhere to the prohibitions and restrictions specified in this protocol
- If a woman, must not be of childbearing potential: postmenopausal (amenorrhea for at least 12 months and a serum follicle stimulating hormone within postmenopausal range); or surgically sterile (hysterectomy, bilateral salpingectomy, bilateral oophorectomy, bilateral tubal occlusion/ligation procedure)
- Blood pressure (after the participant is supine for 5 minutes) between 90 and 140 millimeter of mercury (mmHg) systolic for participants less than or equal to (<=) 60 years old and between 90 and 150 mmHg for participants greater than (>) 60 years old, inclusive, and no higher than 90 mmHg diastolic. If blood pressure is out of range, up to 2 repeated assessments are permitted per visit
- Pharmacogenomics: Healthy participants must have matching glutathione S-transferase Mu 1 (GSTM1) genotype (null or non-null GSTM1 genotype) to individual hepatic impairment group participants
Key exclusion criteria (6 listed)
- Participant has known allergies, hypersensitivity, or intolerance to Lazertinib or its excipients
- Any surgical or medical condition that may alter the absorption, metabolism, or excretion of the study drug (example, gastrectomy, Crohn's disease etc.), with the exception of hepatic impairment
- Active gall bladder or biliary tract disease (example, acute cholecystitis, symptomatic cholelithiasis)
- Participant tests positive for human immunodeficiency virus (HIV)-1 or HIV-2 at screening
- Participant has a lack of adequate venous access
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 |
|---|---|---|
| LazertinibAlso: JNJ-73841937,, YH25448Lazertinib tablet will be administered orally. | Drug | Part A: Group 1: Moderate Hepatic Impairment, Part A: Group 2: Normal Hepatic Function, Part B: Group 3 (Optional): Mild Hepatic Impairment, Part B: Group 4 (Optional): Severe Hepatic Impairment |
Primary outcome
Plasma Concentrations of Lazertinib
Time frame: Predose up to 312 hour postdose (up to Day 14)
Plasma concentrations of lazertinib will be analyzed using a validated, specific, and sensitive method to assess the effect of hepatic impairment on the pharmacokinetic of lazertinib.
1 secondary outcome
Percentage of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability
Time frame: Up to 49 days
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 27 Apr 2025.
- Individual participant dataSharing planned: Yes. The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
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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.
Janssen Research & Development, LLC Clinical Trial study director
Janssen Research & Development, LLC
2 sites 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 in people with Hepatic Impairment and Healthy, run by Janssen Research & Development, LLC at 2 sites in Germany.
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 10 inclusion and 6 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 27 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. 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?
Plasma Concentrations of Lazertinib (time frame: Predose up to 312 hour postdose (up to Day 14)). 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 27 Apr 2025.