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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
32
Lazertinib tablets will be administered orally.
Itraconazole capsules will be administered orally.
Rifampin capsules will be administered orally.
Celerion
Tempe, Arizona, United States
Cohort 1 and 2: Maximum Plasma Concentration (Cmax) of Lazertinib
Cmax is defined as maximum plasma concentration.
Time frame: Predose up to 120 hours post dose
Cohort 1 and 2: Area Under the Plasma Concentration-time Curve from Time 0 to 120 Hours (AUC [0-120h]) of Lazertinib
AUC (0-120h) is defined as area under the plasma concentration-time curve from time 0 to 120 hours postdose.
Time frame: Predose up to 120 hours post dose
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
AUC (0-last) is defined as area under the plasma concentration-time curve from time 0 to time of last quantifiable timepoint.
Time frame: Predose up to 120 hours post dose
Cohort 1 and 2: Area Under the Plasma Concentration-time Curve from Time Zero to Infinity (AUC [0-inf]) of Lazertinib
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.
Time frame: Predose up to 120 hours post dose
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
%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.
Time frame: Predose up to 120 hours post dose
Cohort 1 and Cohort 2: Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability
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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.
Time frame: Up to 65 days (Cohort 1) and up to 70 days (Cohort 2)