HealthyPhase 1NCT04410081
A Study of (14C)-JNJ-73841937 (Lazertinib) in Healthy Male Participants
A Phase 1 study testing 14C-lazertinib in people with Healthy, run by Janssen Research & Development, LLC at 1 site in Netherlands.
Trial summary
The purpose of this study is to characterize the absorption, metabolic pathways of lazertinib, and the excretion of the parent lazertinib and its metabolites, after a single oral dose of 14C-lazertinib in healthy adult male participants. Read more about this study
- Who is it for?
- Ages 18 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- 14C-lazertinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteNetherlands
- Study dates
- 14 Jul 2020to 2 Mar 2021
- 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 60 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Must be healthy on the basis of medical history performed at screening and physical examination and vital signs (pulse rate and body temperature) performed at screening and admission to the study site
- Participants must be healthy on the basis of clinical laboratory tests performed at screening. If the results of the serum chemistry or hematology panel are outside the normal reference ranges, the participant may be included only if the investigator judges the abnormalities or deviations from normal to be not clinically significant. This determination must be recorded in the participant's source documents and initialed by the investigator
- Body mass index (BMI) between 18.0 and 30.0 kilogram per meter square (kg/m^2, inclusive (BMI = weight/height^2), and body weight not less than 50 kg at screening
- Blood pressure at screening and admission to the study site (after the participant supine for 5 minutes) between 90 and 140 millimeter of Mercury (mmHg) systolic, inclusive; and no higher than 90 mmHg diastolic at screening
- A 12-lead electrocardiogram (ECG) consistent with normal cardiac conduction and function, including: Sinus rhythm, Pulse rate between 45 and 100 beats per minute (bpm), corrected QT (QTc) interval less than or equal to (<=) 450 millisecond (msec), QRS interval of less than (<)120 msec, PR interval <210 msec
Who cannot join
- History of infection suspected or confirmed to be related to Coronavirus disease 2019 (COVID-19) within 4 weeks before intake of study drug
- Participant has known allergies, hypersensitivity, or intolerance to lazertinib or any of its excipients
- Participant has a positive test for hepatitis A antibody immunoglobulin M (IgM), hepatitis B surface antigen (HBsAg), hepatitis B (anti-HBc or anti-HBs), or hepatitis C (anti-HCV) antibodies positive at screening. Hepatitis B surface antibody positivity is not exclusionary if participant can provide evidence of Hepatitis B vaccination
- Participant who plans to father a child while enrolled in the study or within 6 months after study drug administration
- Exposure to radiation for professional or medical reasons with the exception of up to 2 standard diagnostic radiographs (example, [dental X-rays, plain chest X-ray]) within 1 year before study drug administration on Study Day 1. Participants cannot have participated in a radiolabeled drug study within 12 months prior to dosing if the dose was higher than 0.1 megabecquerel (MBq)
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
PRA Health Sciences Onderzoekscentrum Groningen, locatie Martini
Groningen, 9728 NZ
About this study
Official title: An Open-Label Study to Investigate the Absorption, Metabolism, and Excretion of [14C]-JNJ-73841937 (Lazertinib) After a Single Oral Dose in Healthy Male Participants
The purpose of this study is to characterize the absorption, metabolic pathways of lazertinib, and the excretion of the parent lazertinib and its metabolites, after a single oral dose of 14C-lazertinib in healthy adult male participants.
- Conditions
- Healthy
- Being tested
- 14C-lazertinib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
14C-lazertinibDrug
Also called JNJ-73841937
A single oral dose of 14C-lazertinib will be administered.
| Study group | Role | What they receive |
|---|---|---|
| 14C-lazertinib | Experimental | Participants will receive a single oral dose of 14C-lazertinib on Day 1. Receives: Drug: 14C-lazertinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Observed Plasma Concentration (Cmax) of 14C-lazertinib
Cmax is defined as maximum observed plasma concentration.
Measured: Up to 99 days
Time to Reach Maximum Observed Plasma Concentration (Tmax) of 14C-lazertinib
Tmax is defined time to reach the maximum observed concentration.
Measured: Up to 99 days
Area Under the Plasma Concentration-time Curve from Time Zero to Time of Last Quantifiable Concentration (AUC [0-last]) of 14C-lazertinib
AUC (0-last) is defined as area under the plasma concentration-time curve from time 0 to the time of last observed quantifiable concentration.
Measured: Up to 99 days
Area Under the Plasma Concentration-time Curve from Time Zero to Infinity (AUC [0-infinity]) of 14C-lazertinib
AUC (0-infinity) is defined as area under the plasma concentration-time curve from time 0 to infinity, calculated as the sum of AUC(0-last)+C(last)/ lambda(z), where C(last) is the last observed quantifiable concentration, and lambda(z) is elimination rate constant.
Measured: Up to 99 days
Elimination Half-life (t1/2) of 14C-lazertinib
Elimination half-life associated with the terminal slope lambda(z) of the semilogarithmic drug concentration-time curve, calculated as 0.693/lambda(z).
Measured: Up to 99 days
Apparent Terminal Elimination Rate Constant (Lambda[z])
Lambda(z) is defined as apparent terminal elimination rate constant, estimated by linear regression using the terminal log-linear phase of the log transformed concentration vs time data.
Measured: Up to 99 days
Total Apparent Clearance (CL/F) of 14C-lazertinib
Clearance is a quantitative measure of the rate at which a drug substance is removed from the body, calculated as dose/AUC (0-infinity).
Measured: Up to 99 days
Apparent Volume of Distribution (Vdz/F) of 14C-lazertinib
Apparent volume of distribution, calculated as dose/(Lambda(z)*AUC (0-infinity).
Measured: Up to 99 days
Ratio of Blood to Plasma Total Radioactivity of 14C-lazertinib
Blood to plasma total radioactivity ratio, calculated as blood total radioactivity/plasma total radioactivity.
Measured: Up to 99 days
Ratio of AUC (0-infinity) of 14C-lazertinib to AUC (0-infinity) of Total Radioactivity in Plasma
The ratio of AUC (0-infinity) of 14C-lazertinib to AUC (0-infinity) of total radioactivity in plasma will be assessed.
Measured: Up to 99 days
Ratio of AUC (0-last) of 14C-lazertinib Concentration to AUC (0-last) of Total Radioactivity in Plasma
The ratio of AUC (0-last) of 14C-lazertinib to AUC (0-last) of total radioactivity in plasma will be assessed.
Measured: Up to 99 days
Ratio of Cmax of 14C-lazertinib to Cmax of Total Radioactivity in Plasma
The ratio of Cmax of 14C-lazertinib to Cmax of total radioactivity in plasma will be assessed.
Measured: Up to 99 days
Ratio of 14C-lazertinib Concentration to Total Radioactivity in Plasma
The ratio of 14C-lazertinib concentration to total radioactivity in plasma for each sampling time point will be assessed.
Measured: Up to 99 days
Amount of 14C-lazertinib Excreted in Urine (Ae[t1-t2])
Amount excreted into the urine during a collection interval, where t1 and t2 are the start and end times of the collection interval, and calculated by multiplying the urinary volume with the urinary concentration for that interval.
Measured: Up to 99 days
Cumulative Amount of 14C-lazertinib Excreted in Urine (Ae)
Cumulative amount excreted into the urine over the entire collection period, calculated as the sum of Ae's across the collection intervals for each participant.
Measured: Up to 99 days
Percentage of 14C-lazertinib Dose Excreted in Urine (%Ae)
Cumulative amount excreted into the urine, expressed as a percentage of the administered dose, calculated as (Ae divided by dose)*100.
Measured: Up to 99 days
Renal Clearance (CLr) of 14C-lazertinib
The CLr is the renal clearance of the drug, calculated as Ae/AUC(0-infinity).
Measured: Up to 99 days
Amount of 14C-lazertinib Excreted in Feces (Fe[t1-t2])
Amount excreted into the feces during a collection interval, where t1 and t2 are the start and end times of the collection interval, and calculated by multiplying the feces weight with the feces concentration for that interval.
Measured: Up to 99 days
Cumulative Amount of 14C-lazertinib Excreted in Feces (Fe)
Cumulative amount excreted into the feces over the entire collection period, calculated as the sum of Fe's across the collection intervals for each participant.
Measured: Up to 99 days
Percentage of 14C-lazertinib Dose Excreted in Feces (%Fe)
Cumulative amount excreted into the feces, expressed as a percentage of the administered dose, calculated as (Fe divided by dose)*100.
Measured: Up to 99 days
Total Recovery of 14C-lazertinib Dose in Feces and Urine
Total recovery, calculated as sum of %Ae and %Fe.
Measured: Up to 99 days
Secondary outcomes (1)
Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability
An AE is any untoward medical occurrence in a clinical study participant administered a investigational or non investigational medicinal product. An AE does not necessarily have a causal relationship with the treatment.
Measured: Up to 135 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2020
- Study start14 Jul 2020
- Primary completion2 Mar 2021
- Study completion2 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 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
- NCT04410081
- Sponsor's protocol ID
- CR108791
- Other IDs
- 73841937NSC1004, 2020-000646-34
- Status last verified
- Mar 2021
- First submitted
- 28 May 2020
- Last updated
- 29 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- 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 29 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Study to Investigate the Absorption, Metabolism, and Excretion of [14C]-JNJ-73841937 (Lazertinib) After a Single Oral Dose in Healthy Male Participants
- ClinicalTrials.gov ID
- NCT04410081
- Acronym / sponsor ID
- CR108791
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
- Study start
- 14 Jul 2020 (actual)
- Primary completion
- 2 Mar 2021 (actual)
- Study completion
- 2 Mar 2021 (actual)
- First posted
- 1 Jun 2020 (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 characterize the absorption, metabolic pathways of lazertinib, and the excretion of the parent lazertinib and its metabolites, after a single oral dose of 14C-lazertinib in healthy adult male participants.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 14C-lazertinib | Experimental | Drug: 14C-lazertinibParticipants will receive a single oral dose of 14C-lazertinib on Day 1. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Must be healthy on the basis of medical history performed at screening and physical examination and vital signs (pulse rate and body temperature) performed at screening and admission to the study site
- Participants must be healthy on the basis of clinical laboratory tests performed at screening. If the results of the serum chemistry or hematology panel are outside the normal reference ranges, the participant may be included only if the investigator judges the abnormalities or deviations from normal to be not clinically significant. This determination must be recorded in the participant's source documents and initialed by the investigator
- Body mass index (BMI) between 18.0 and 30.0 kilogram per meter square (kg/m^2, inclusive (BMI = weight/height^2), and body weight not less than 50 kg at screening
- Blood pressure at screening and admission to the study site (after the participant supine for 5 minutes) between 90 and 140 millimeter of Mercury (mmHg) systolic, inclusive; and no higher than 90 mmHg diastolic at screening
- A 12-lead electrocardiogram (ECG) consistent with normal cardiac conduction and function, including: Sinus rhythm, Pulse rate between 45 and 100 beats per minute (bpm), corrected QT (QTc) interval less than or equal to (<=) 450 millisecond (msec), QRS interval of less than (<)120 msec, PR interval <210 msec
Key exclusion criteria (5 listed)
- History of infection suspected or confirmed to be related to Coronavirus disease 2019 (COVID-19) within 4 weeks before intake of study drug
- Participant has known allergies, hypersensitivity, or intolerance to lazertinib or any of its excipients
- Participant has a positive test for hepatitis A antibody immunoglobulin M (IgM), hepatitis B surface antigen (HBsAg), hepatitis B (anti-HBc or anti-HBs), or hepatitis C (anti-HCV) antibodies positive at screening. Hepatitis B surface antibody positivity is not exclusionary if participant can provide evidence of Hepatitis B vaccination
- Participant who plans to father a child while enrolled in the study or within 6 months after study drug administration
- Exposure to radiation for professional or medical reasons with the exception of up to 2 standard diagnostic radiographs (example, [dental X-rays, plain chest X-ray]) within 1 year before study drug administration on Study Day 1. Participants cannot have participated in a radiolabeled drug study within 12 months prior to dosing if the dose was higher than 0.1 megabecquerel (MBq)
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 |
|---|---|---|
| 14C-lazertinibAlso: JNJ-73841937A single oral dose of 14C-lazertinib will be administered. | Drug | 14C-lazertinib |
Primary outcome
Maximum Observed Plasma Concentration (Cmax) of 14C-lazertinib
Time frame: Up to 99 days
Cmax is defined as maximum observed plasma concentration.
Time to Reach Maximum Observed Plasma Concentration (Tmax) of 14C-lazertinib
Time frame: Up to 99 days
Tmax is defined time to reach the maximum observed concentration.
Area Under the Plasma Concentration-time Curve from Time Zero to Time of Last Quantifiable Concentration (AUC [0-last]) of 14C-lazertinib
Time frame: Up to 99 days
AUC (0-last) is defined as area under the plasma concentration-time curve from time 0 to the time of last observed quantifiable concentration.
Area Under the Plasma Concentration-time Curve from Time Zero to Infinity (AUC [0-infinity]) of 14C-lazertinib
Time frame: Up to 99 days
AUC (0-infinity) is defined as area under the plasma concentration-time curve from time 0 to infinity, calculated as the sum of AUC(0-last)+C(last)/ lambda(z), where C(last) is the last observed quantifiable concentration, and lambda(z) is elimination rate constant.
Elimination Half-life (t1/2) of 14C-lazertinib
Time frame: Up to 99 days
Elimination half-life associated with the terminal slope lambda(z) of the semilogarithmic drug concentration-time curve, calculated as 0.693/lambda(z).
Apparent Terminal Elimination Rate Constant (Lambda[z])
Time frame: Up to 99 days
Lambda(z) is defined as apparent terminal elimination rate constant, estimated by linear regression using the terminal log-linear phase of the log transformed concentration vs time data.
Total Apparent Clearance (CL/F) of 14C-lazertinib
Time frame: Up to 99 days
Clearance is a quantitative measure of the rate at which a drug substance is removed from the body, calculated as dose/AUC (0-infinity).
Apparent Volume of Distribution (Vdz/F) of 14C-lazertinib
Time frame: Up to 99 days
Apparent volume of distribution, calculated as dose/(Lambda(z)*AUC (0-infinity).
Ratio of Blood to Plasma Total Radioactivity of 14C-lazertinib
Time frame: Up to 99 days
Blood to plasma total radioactivity ratio, calculated as blood total radioactivity/plasma total radioactivity.
Ratio of AUC (0-infinity) of 14C-lazertinib to AUC (0-infinity) of Total Radioactivity in Plasma
Time frame: Up to 99 days
The ratio of AUC (0-infinity) of 14C-lazertinib to AUC (0-infinity) of total radioactivity in plasma will be assessed.
Ratio of AUC (0-last) of 14C-lazertinib Concentration to AUC (0-last) of Total Radioactivity in Plasma
Time frame: Up to 99 days
The ratio of AUC (0-last) of 14C-lazertinib to AUC (0-last) of total radioactivity in plasma will be assessed.
Ratio of Cmax of 14C-lazertinib to Cmax of Total Radioactivity in Plasma
Time frame: Up to 99 days
The ratio of Cmax of 14C-lazertinib to Cmax of total radioactivity in plasma will be assessed.
Ratio of 14C-lazertinib Concentration to Total Radioactivity in Plasma
Time frame: Up to 99 days
The ratio of 14C-lazertinib concentration to total radioactivity in plasma for each sampling time point will be assessed.
Amount of 14C-lazertinib Excreted in Urine (Ae[t1-t2])
Time frame: Up to 99 days
Amount excreted into the urine during a collection interval, where t1 and t2 are the start and end times of the collection interval, and calculated by multiplying the urinary volume with the urinary concentration for that interval.
Cumulative Amount of 14C-lazertinib Excreted in Urine (Ae)
Time frame: Up to 99 days
Cumulative amount excreted into the urine over the entire collection period, calculated as the sum of Ae's across the collection intervals for each participant.
Percentage of 14C-lazertinib Dose Excreted in Urine (%Ae)
Time frame: Up to 99 days
Cumulative amount excreted into the urine, expressed as a percentage of the administered dose, calculated as (Ae divided by dose)*100.
Renal Clearance (CLr) of 14C-lazertinib
Time frame: Up to 99 days
The CLr is the renal clearance of the drug, calculated as Ae/AUC(0-infinity).
Amount of 14C-lazertinib Excreted in Feces (Fe[t1-t2])
Time frame: Up to 99 days
Amount excreted into the feces during a collection interval, where t1 and t2 are the start and end times of the collection interval, and calculated by multiplying the feces weight with the feces concentration for that interval.
Cumulative Amount of 14C-lazertinib Excreted in Feces (Fe)
Time frame: Up to 99 days
Cumulative amount excreted into the feces over the entire collection period, calculated as the sum of Fe's across the collection intervals for each participant.
Percentage of 14C-lazertinib Dose Excreted in Feces (%Fe)
Time frame: Up to 99 days
Cumulative amount excreted into the feces, expressed as a percentage of the administered dose, calculated as (Fe divided by dose)*100.
Total Recovery of 14C-lazertinib Dose in Feces and Urine
Time frame: Up to 99 days
Total recovery, calculated as sum of %Ae and %Fe.
1 secondary outcome
Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability
Time frame: Up to 135 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 29 Mar 2021.
- 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
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 14C-lazertinib in people with Healthy, run by Janssen Research & Development, LLC at 1 site in Netherlands.
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 5 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 29 Mar 2021. 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 Netherlands. 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?
Maximum Observed Plasma Concentration (Cmax) of 14C-lazertinib (time frame: Up to 99 days). The study lists 21 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 29 Mar 2021.