Clinical trial NCT05896683: A Study of Lazertinib (JNJ-73841937) Tablet in Healthy Adult Participants
Official title: A Phase 1, Open-label, Randomized, 2-Part, 2-Way Crossover Study in Healthy Adult Participants to Assess the Relative Bioavailability of Tablet Formulations of Lazertinib (JNJ-73841937)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2023-06-09
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to assess the extent of availability of drug to the body of four different lazertinib tablet formulations at a single oral dose under fasted conditions in healthy adult participants.


Eligibility criteria: Inclusion Criteria:

* Healthy on the basis of physical examination, medical history (at screening only), vital signs, and 12-lead electrocardiogram (ECG) performed at screening and at admission to the study site in Intervention Period 1
* Body weight not less than 50.0 kilograms (kgs) and body mass index (BMI, weight/height\^2) within the range 19.0-30.0 kg/m\^2 (inclusive) at screening
* All female participants must have a negative highly sensitive serum beta-human chorionic gonadotropin (beta-HCG) test at screening and a negative urine pregnancy test on Day -1 of Intervention Period 1
* A male participant must agree not to donate sperm for the purpose of reproduction during the study and for a minimum of 6 months after receiving the last dose of study intervention
* Must sign an ICF indicating that the participant understands the purpose of, and procedures required for, the study and is willing to participate in the study

Exclusion Criteria:

* History of or current clinically significant medical illness including (but not limited to) cardiac arrhythmias or other cardiac disease, hematologic disease, coagulation disorders (including any abnormal bleeding or blood dyscrasias), lipid abnormalities, significant pulmonary disease, including bronchospastic respiratory disease and interstitial lung disease, diabetes mellitus (with the exception of history of gestational diabetes), hepatic insufficiency, inflammation bowel disease/Crohn's disease, thyroid disease, neurologic or psychiatric disease, infection, or any other illness that the investigator considers should exclude the participant or that could interfere with the interpretation of the study results
* History of stomach or intestinal surgery or resection, including cholecystectomy, that would potentially alter absorption or excretion of orally administered drugs
* History of malignancy within 5 years before screening
* Use of any prescription or nonprescription medication (including vitamins and herbal supplements), except for paracetamol, ibuprofen, and stable hormone replacement therapy (in postmenopausal female participants only) within 14 days before the first dose of study intervention is scheduled until completion of the study
* History of human immunodeficiency virus (HIV) antibody positive, or tests positive for HIV at screening

Primary outcomes:
measure: Part 1: Maximum Observed Plasma Concentration (Cmax) of Lazertinib
timeFrame: Pre dose up to 168 hours post dose on Day 1
measure: Part 2: Maximum Observed Plasma Concentration (Cmax) of Lazertinib
timeFrame: Pre dose up to 168 hours post dose on Day 1
measure: Part 1: Area Under the Plasma Concentration-time Curve from Time 0 to 72 Hours (h) (AUC[0-72h]) of Lazertinib
timeFrame: Pre dose up to 72 hours post dose on Day 1
measure: Part 2: Area Under the Plasma Concentration-time Curve from Time 0 to 72h (AUC[0-72h]) of Lazertinib
timeFrame: Pre dose up to 72 hours post dose on Day 1
Secondary outcomes:
measure: Number of Participants With Adverse Events (AEs)
timeFrame: Up to 8 Weeks
measure: Number of Participants With Serious Adverse Events (SAEs)
timeFrame: Up to 8 Weeks
measure: Number of Participants With AEs by Severity
timeFrame: Up to 8 Weeks
measure: Number of Participants With Change From Baseline in Clinical Laboratory Test Values
timeFrame: Up to 8 Weeks
measure: Number of Participants With Change From Baseline in 12-lead Electrocardiograms (ECGs)
timeFrame: Up to 8 Weeks
measure: Number of Participants With Change From Baseline in Vital Signs
timeFrame: Up to 8 Weeks
measure: Number of Participants With Change From Baseline in Physical Examination
timeFrame: Up to 8 Weeks
Other outcomes:
Locations:
city: Edegem
country: Belgium
facility: SGS Belgium NV
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References: