The purpose of this study is to assess the bioequivalence of four different lazertinib oral tablet formulations in healthy adult participants under fasted condition.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
64
Lazertinib will be administered orally.
Celerion
Tempe, Arizona, United States
Interventions A, B and C: Maximum Observed Plasma Concentration (Cmax) of Lazertinib
Cmax is defined as maximum observed plasma concentration.
Time frame: Pre dose up to 168 hours post dose
Interventions A, B and C: Area Under the Plasma Concentration-time Curve from Time 0 to 72 Hours (h) (AUC[0-72h]) of Lazertinib
AUC (0-72h) is the area under the plasma concentration-time curve from time 0 to 72 hours.
Time frame: Pre dose up to 168 hours post dose
Interventions A and D: Maximum Observed Plasma Concentration (Cmax) of Lazertinib
Cmax is defined as maximum observed plasma concentration.
Time frame: Pre dose up to 168 hours post dose
Interventions A and D: Area Under the Plasma Concentration-time Curve from Time of 0 to 72 Hours [AUC (0-72h)] of Lazertinib
AUC (0-72h) is the area under the plasma concentration-time curve from time 0 to 72 hours.
Time frame: Pre dose up to 168 hours post dose
Number of Participants With Adverse Events (AEs)
AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.
Time frame: Up to 14 weeks
Number of Participants With Serious Adverse Events (SAEs)
A SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
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Time frame: Up to 14 weeks
Number of Participants With AEs by Severity
Number of participants with AEs by severity will be reported. Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. Severity scale ranges from grade 1 (mild) to grade 5 (death). Grade 1= mild, Grade 2= moderate, Grade 3= severe, Grade 4= life-threatening and Grade 5= death related to adverse event.
Time frame: Up to 14 weeks
Number of Participants With Change From Baseline in Clinical Laboratory Test Values
Number of participants with change from baseline in clinical laboratory test values (including hematology and clinical chemistry) will be reported.
Time frame: Up to 14 weeks
Number of Participants With Change From Baseline in 12-lead Electrocardiograms (ECGs)
Number of participants with change from baseline in 12-lead ECGs will be reported.
Time frame: Up to 14 weeks
Number of Participants With Change From Baseline in Vital Signs
Number of participants with change from baselines in vital signs (including temperature \[oral\], pulse/heart rate, respiratory rate, and blood pressure) will be reported.
Time frame: Up to 14 weeks
Number of Participants With Change From Baseline in Physical Examination
Number of participants with change from baseline in physical examination (including height and body weight) will be reported.
Time frame: Up to 14 weeks