Clinical trial NCT05742594: A Study of Four Different Oral Tablet Formulations of Lazertinib (JNJ-73841937) in Healthy Adult Participants
Official title: A Phase 1, Open-label, Randomized, 4-Way Crossover Pivotal Study to Assess the Bioequivalence of Four Different Oral Tablet Formulations of Lazertinib (JNJ-73841937) in Healthy Adult Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2023-02-24
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to assess the bioequivalence of four different lazertinib oral tablet formulations in healthy adult participants under fasted condition.


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
* All female participants must have a negative highly sensitive serum Beta-human chorionic gonadotropin (Beta-HCG) at screening and 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 informed consent form (ICF) indicating that the participant understands the purpose of, and procedures required for, the study and is willing to participate in the study
* Female participants must be postmenopausal or surgically sterile

Exclusion Criteria:

* 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
* Known allergies, hypersensitivity, or intolerance to lazertinib or its excipients
* Participant has a history of clinically significant allergies
* Had major surgery, (for example, requiring general anesthesia) within 8 weeks before screening, or will not have fully recovered from the surgery, or has surgery planned during the time the participant is expected to participate in the study or within 4 weeks after the last dose of study intervention administration

Primary outcomes:
measure: Interventions A, B and C: Maximum Observed Plasma Concentration (Cmax) of Lazertinib
timeFrame: Pre dose up to 168 hours post dose
measure: Interventions A, B and C: Area Under the Plasma Concentration-time Curve from Time 0 to 72 Hours (h) (AUC[0-72h]) of Lazertinib
timeFrame: Pre dose up to 168 hours post dose
Secondary outcomes:
measure: Interventions A and D: Maximum Observed Plasma Concentration (Cmax) of Lazertinib
timeFrame: Pre dose up to 168 hours post dose
measure: Interventions A and D: Area Under the Plasma Concentration-time Curve from Time of 0 to 72 Hours [AUC (0-72h)] of Lazertinib
timeFrame: Pre dose up to 168 hours post dose
measure: Number of Participants With Adverse Events (AEs)
timeFrame: Up to 14 weeks
measure: Number of Participants With Serious Adverse Events (SAEs)
timeFrame: Up to 14 weeks
measure: Number of Participants With AEs by Severity
timeFrame: Up to 14 weeks
measure: Number of Participants With Change From Baseline in Clinical Laboratory Test Values
timeFrame: Up to 14 weeks
measure: Number of Participants With Change From Baseline in 12-lead Electrocardiograms (ECGs)
timeFrame: Up to 14 weeks
measure: Number of Participants With Change From Baseline in Vital Signs
timeFrame: Up to 14 weeks
measure: Number of Participants With Change From Baseline in Physical Examination
timeFrame: Up to 14 weeks
Other outcomes:
Locations:
city: Tempe
country: United States
facility: Celerion
state: Arizona
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trail
role: STUDY_DIRECTOR
References: