Healthy
Conditions
Brief 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.
Interventions
DRUGLazertinib
Lazertinib tablets will be administered orally.
DRUGItraconazole
Itraconazole capsules will be administered orally.
DRUGRifampin
Rifampin capsules will be administered orally.
Sponsors
Janssen Research & Development, LLC
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cohort 1 and 2: Maximum Plasma Concentration (Cmax) of Lazertinib | 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 | 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 | 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 | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cohort 1 and Cohort 2: Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability | Up to 65 days (Cohort 1) and up to 70 days (Cohort 2) | 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. |
Countries
United States
Outcome results
None listed