HealthyPhase 1NCT04410094
A Study to Assess the Effects of Itraconazole and Rifampin on Lazertinib in Healthy Adult Participants
A Phase 1 study testing Lazertinib, Itraconazole and Rifampin in people with Healthy, run by Janssen Research & Development, LLC at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the effects of multiple doses of strong cytochrome P450 (CYP) 3A4 inhibitor itraconazole and strong CYP3A4 inducer rifampin on the single dose pharmacokinetics (PK) of lazertinib in healthy adult participants. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Lazertinib, Itraconazole and Rifampin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Sep 2020to 2 Feb 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
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- A woman must not be of childbearing potential and must have a negative serum beta-human chorionic gonadotropin (Beta HCG) pregnancy test at screening
- Hormone replacement therapy (if applicable) must have been discontinued at least 28 days prior to the first dose of study drug (Cohort 2 only)
- Participants must have a body mass index (BMI) between 18.0 and 32.0 kilogram per meter square (kg/m^2, inclusive (BMI = weight/height^2), and body weight not less than 50 kg at screening
- Participants must be healthy based on physical examination, medical history, and vital signs (pulse and body temperature), performed at screening
- Male participants must agree to use an adequate contraception method
Who cannot join
- History of or current clinically significant medical illness that the investigator considers should exclude the participant or that could interfere with the interpretation of the study results
- 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 its excipients or to itraconazole and rifampin
- Participant has contraindications to the use itraconazole and rifampin per local prescribing information
- Use of any cytochrome P450 (CYP) 3A4 inhibitors or inducers (other than per-protocol itraconazole/rifampin administration) within 4 weeks before the first dose of the study drug is scheduled until completion of the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1 Open-Label, Fixed-Sequence Drug-Drug Interaction Study to Evaluate the Effects of Steady-state Itraconazole and Rifampin on the Single-dose Pharmacokinetics of Lazertinib Tablets in Healthy Adult Participants
The purpose of this study is to evaluate the effects of multiple doses of strong cytochrome P450 (CYP) 3A4 inhibitor itraconazole and strong CYP3A4 inducer rifampin on the single dose pharmacokinetics (PK) of lazertinib in healthy adult participants.
- Conditions
- Healthy
- Being tested
- Lazertinib, Itraconazole, Rifampin
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 tablets will be administered orally.
ItraconazoleDrug
Itraconazole capsules will be administered orally.
RifampinDrug
Rifampin capsules will be administered orally.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: Lazertinib plus Itraconazole | Experimental | Participants will receive a single oral dose of lazertinib tablets in Treatment Period 1 followed by itraconazole capsules orally along with a single oral dose of lazertinib tablet in Treatment Period 2. Receives: Drug: Lazertinib; Drug: Itraconazole |
| Cohort 2: Lazertinib plus Rifampin | Experimental | Participants will receive a single oral dose of lazertinib tablets in Treatment Period 1 followed by rifampin capsules orally along with a single oral dose of lazertinib tablet in Treatment Period 2. Receives: Drug: Lazertinib; Drug: Rifampin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cohort 1 and 2: Maximum Plasma Concentration (Cmax) of Lazertinib
Cmax is defined as maximum plasma concentration.
Measured: Predose up to 120 hours post dose
Cohort 1 and 2: Area Under the Plasma Concentration-time Curve from Time 0 to 120 Hours (AUC [0-120h]) of Lazertinib
AUC (0-120h) is defined as area under the plasma concentration-time curve from time 0 to 120 hours postdose.
Measured: Predose up to 120 hours post dose
Cohort 1 and 2: Area Under the Plasma Concentration-time Curve from Time Zero to Time of Last Quantifiable Timepoint (AUC [0-last]) of Lazertinib
AUC (0-last) is defined as area under the plasma concentration-time curve from time 0 to time of last quantifiable timepoint.
Measured: Predose up to 120 hours post dose
Cohort 1 and 2: Area Under the Plasma Concentration-time Curve from Time Zero to Infinity (AUC [0-inf]) of Lazertinib
AUC (0-inf) 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 measurable (non-below limit of quantification) concentration.
Measured: Predose up to 120 hours post dose
Cohort 1 and 2: Percentage of Area Under the Plasma Concentration from time Zero to Infinite time obtained by Extrapolation (%AUC [0-inf],ex) of Lazertinib
%AUC (0-inf),ex is defined as percentage of area under the plasma concentration from time zero to infinite time obtained by extrapolation, calculated as (AUC [0-infinity] minus AUC [0-last]/AUC [0-infinity])*100.
Measured: Predose up to 120 hours post dose
Secondary outcomes (1)
Cohort 1 and Cohort 2: 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 65 days (Cohort 1) and up to 70 days (Cohort 2)
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 Sep 2020
- Primary completion30 Dec 2020
- Study completion2 Feb 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 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
- NCT04410094
- Sponsor's protocol ID
- CR108799
- Other IDs
- 73841937NSC1003
- Status last verified
- Feb 2021
- First submitted
- 28 May 2020
- Last updated
- 1 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 1 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Open-Label, Fixed-Sequence Drug-Drug Interaction Study to Evaluate the Effects of Steady-state Itraconazole and Rifampin on the Single-dose Pharmacokinetics of Lazertinib Tablets in Healthy Adult Participants
- ClinicalTrials.gov ID
- NCT04410094
- Acronym / sponsor ID
- CR108799
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
- Study start
- 14 Sep 2020 (actual)
- Primary completion
- 30 Dec 2020 (actual)
- Study completion
- 2 Feb 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 evaluate the effects of multiple doses of strong cytochrome P450 (CYP) 3A4 inhibitor itraconazole and strong CYP3A4 inducer rifampin on the single dose pharmacokinetics (PK) of lazertinib in healthy adult participants.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: Lazertinib plus Itraconazole | Experimental | Drug: Lazertinib, Drug: ItraconazoleParticipants will receive a single oral dose of lazertinib tablets in Treatment Period 1 followed by itraconazole capsules orally along with a single oral dose of lazertinib tablet in Treatment Period 2. |
| Cohort 2: Lazertinib plus Rifampin | Experimental | Drug: Lazertinib, Drug: RifampinParticipants will receive a single oral dose of lazertinib tablets in Treatment Period 1 followed by rifampin capsules orally along with a single oral dose of lazertinib tablet in Treatment Period 2. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- A woman must not be of childbearing potential and must have a negative serum beta-human chorionic gonadotropin (Beta HCG) pregnancy test at screening
- Hormone replacement therapy (if applicable) must have been discontinued at least 28 days prior to the first dose of study drug (Cohort 2 only)
- Participants must have a body mass index (BMI) between 18.0 and 32.0 kilogram per meter square (kg/m^2, inclusive (BMI = weight/height^2), and body weight not less than 50 kg at screening
- Participants must be healthy based on physical examination, medical history, and vital signs (pulse and body temperature), performed at screening
- Male participants must agree to use an adequate contraception method
Key exclusion criteria (5 listed)
- History of or current clinically significant medical illness that the investigator considers should exclude the participant or that could interfere with the interpretation of the study results
- 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 its excipients or to itraconazole and rifampin
- Participant has contraindications to the use itraconazole and rifampin per local prescribing information
- Use of any cytochrome P450 (CYP) 3A4 inhibitors or inducers (other than per-protocol itraconazole/rifampin administration) within 4 weeks before the first dose of the study drug is scheduled until completion of the study
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 tablets will be administered orally. | Drug | Cohort 1: Lazertinib plus Itraconazole, Cohort 2: Lazertinib plus Rifampin |
| ItraconazoleItraconazole capsules will be administered orally. | Drug | Cohort 1: Lazertinib plus Itraconazole |
| RifampinRifampin capsules will be administered orally. | Drug | Cohort 2: Lazertinib plus Rifampin |
Primary outcome
Cohort 1 and 2: Maximum Plasma Concentration (Cmax) of Lazertinib
Time frame: Predose up to 120 hours post dose
Cmax is defined as maximum plasma concentration.
Cohort 1 and 2: Area Under the Plasma Concentration-time Curve from Time 0 to 120 Hours (AUC [0-120h]) of Lazertinib
Time frame: Predose up to 120 hours post dose
AUC (0-120h) is defined as area under the plasma concentration-time curve from time 0 to 120 hours postdose.
Cohort 1 and 2: Area Under the Plasma Concentration-time Curve from Time Zero to Time of Last Quantifiable Timepoint (AUC [0-last]) of Lazertinib
Time frame: Predose up to 120 hours post dose
AUC (0-last) is defined as area under the plasma concentration-time curve from time 0 to time of last quantifiable timepoint.
Cohort 1 and 2: Area Under the Plasma Concentration-time Curve from Time Zero to Infinity (AUC [0-inf]) of Lazertinib
Time frame: Predose up to 120 hours post dose
AUC (0-inf) 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 measurable (non-below limit of quantification) concentration.
Cohort 1 and 2: Percentage of Area Under the Plasma Concentration from time Zero to Infinite time obtained by Extrapolation (%AUC [0-inf],ex) of Lazertinib
Time frame: Predose up to 120 hours post dose
%AUC (0-inf),ex is defined as percentage of area under the plasma concentration from time zero to infinite time obtained by extrapolation, calculated as (AUC [0-infinity] minus AUC [0-last]/AUC [0-infinity])*100.
1 secondary outcome
Cohort 1 and Cohort 2: Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability
Time frame: Up to 65 days (Cohort 1) and up to 70 days (Cohort 2)
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 1 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 Lazertinib, Itraconazole and Rifampin in people with Healthy, run by Janssen Research & Development, LLC at 1 site in United States.
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 1 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 United States. 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?
Cohort 1 and 2: Maximum Plasma Concentration (Cmax) of Lazertinib (time frame: Predose up to 120 hours post dose). The study lists 5 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 1 Mar 2021.