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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
72
Lazertinib will be administered orally.
SGS Belgium NV
Edegem, Belgium
Part 1: Maximum Observed Plasma Concentration (Cmax) of Lazertinib
Cmax is defined as maximum observed plasma concentration of lazertinib.
Time frame: Pre dose up to 168 hours post dose on Day 1
Part 2: Maximum Observed Plasma Concentration (Cmax) of Lazertinib
Cmax is defined as maximum observed plasma concentration of lazertinib.
Time frame: Pre dose up to 168 hours post dose on Day 1
Part 1: 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 72 hours post dose on Day 1
Part 2: Area Under the Plasma Concentration-time Curve from Time 0 to 72h (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 72 hours post dose on Day 1
Number of Participants With Adverse Events (AEs)
An 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 intervention.
Time frame: Up to 8 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.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: Up to 8 Weeks
Number of Participants With AEs by Severity
An AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. 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 to 5, where 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 8 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 serum chemistry) will be reported.
Time frame: Up to 8 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 8 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 rate, and blood pressure) will be reported.
Time frame: Up to 8 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 8 Weeks