A Phase 1 interventional study of Lazertinib in Healthy, sponsored by Janssen Research & Development, LLC. Completed at 1 site in Belgium. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-02-03.
Sponsored by Janssen Research & Development, LLC · Phase 1, Interventional, and Basic science
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.
Janssen Research & Development, LLC is the lead sponsor of 912 studies on the registry; 76 are open to participants now.
Of its 278 completed or terminated interventional studies of FDA-regulated products, 131 (47%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants will receive intervention A (lazertinib reference formulation) on Day 1 of intervention period 1. After washout period of 14 to 21 days, participants will receive intervention B (lazertinib test formulation) on Day 1 of intervention period 2.
Drug: Lazertinib
Participants will receive intervention B (lazertinib test formulation) on Day 1 of intervention period 1. After washout period of 14 to 21 days, participants will receive intervention A (lazertinib reference formulation) on Day 1 of intervention period 2.
Drug: Lazertinib
Participants will receive Intervention C (lazertinib reference formulation) on Day 1 of intervention period 1. After washout period of 14 to 21 days, participants will receive intervention D (lazertinib test formulation) on Day 1 of intervention period 2.
Drug: Lazertinib
Participants will receive intervention D (lazertinib test formulation) on Day 1 of intervention period 1. After washout period of 14 to 21 days, participants will receive intervention C (lazertinib reference formulation) on Day 1 of intervention period 2.
Drug: Lazertinib
Lazertinib will be administered orally.
Also known as: JNJ-73841937
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.
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
Plan to share: Yes — The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
No publications or documents are linked to this record.
This study is completed, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
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