A Study of Four Different Oral Tablet Formulations of Lazertinib (JNJ-73841937) in Healthy Adult Participants

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

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 Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Lazertinib

• Study Type: Interventional
• Enrollment (Actual): 64
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Tempe, Arizona, United States, 85283
      • Celerion

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Sequence: ADBC; Participants will receive intervention A (lazertinib reference formulation) on Day 1 of intervention Period 1, followed by intervention D (lazertinib test formulation) on Day 1 of intervention Period 2, followed by intervention B (lazertinib test formulation) on Day 1 of intervention Period 3 followed by intervention C (lazertinib test formulation) on Day 1 of Intervention Period 4. There will be a wash-out period of at least 14 days and up to 21 days between each intervention period.	Drug: Lazertinib; Lazertinib will be administered orally.; Other Names: JNJ-73841937
Experimental: Intervention Sequence: BACD; Participants will receive intervention B (lazertinib test formulation) on Day 1 of intervention Period 1, followed by intervention A (lazertinib reference formulation) on Day 1 of intervention Period 2, followed by intervention C (lazertinib test formulation) on Day 1 of intervention Period 3 followed by intervention D (lazertinib test formulation) on Day 1 of intervention Period 4. There will be a wash-out period of at least 14 days and up to 21 days between each intervention period.	Drug: Lazertinib; Lazertinib will be administered orally.; Other Names: JNJ-73841937
Experimental: Intervention Sequence: CBDA; Participants will receive intervention C (lazertinib test formulation) on Day 1 of intervention Period 1, followed by intervention B (lazertinib test formulation) on Day 1 of intervention Period 2, followed by intervention D (lazertinib test formulation) on Day 1 of intervention Period 3 followed by intervention A (lazertinib reference formulation) on Day 1 of intervention Period 4. There will be a wash-out period of at least 14 days and up to 21 days between each intervention period.	Drug: Lazertinib; Lazertinib will be administered orally.; Other Names: JNJ-73841937
Experimental: Intervention Sequence: DCAB; Participants will receive intervention D (lazertinib test formulation) on Day 1 of intervention Period 1, followed by intervention C (lazertinib test formulation) on Day 1 of intervention Period 2, followed by intervention A (lazertinib reference formulation) on Day 1 of intervention Period 3 followed by intervention B (lazertinib test formulation) on Day 1 of intervention Period 4. There will be a wash-out period of at least 14 days and up to 21 days between each intervention period.	Drug: Lazertinib; Lazertinib will be administered orally.; Other Names: JNJ-73841937

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Interventions A, B and C: Maximum Observed Plasma Concentration (Cmax) of Lazertinib	Cmax is defined as maximum observed plasma concentration.	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.	Pre dose up to 168 hours post dose

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Interventions A and D: Maximum Observed Plasma Concentration (Cmax) of Lazertinib	Cmax is defined as maximum observed plasma concentration.	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.	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.	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.	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.	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.	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.	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.	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.	Up to 14 weeks

Collaborators and Investigators

• Sponsor: Janssen Research & Development, LLC
• Investigators: Study Director: Janssen Research & Development, LLC Clinical Trail, Janssen Research & Development, LLC

Study record dates

Study Major Dates

• Study Start (Actual): January 3, 2023
• Primary Completion (Actual): March 31, 2023
• Study Completion (Actual): April 3, 2023

Study Registration Dates

• First Submitted: February 15, 2023
• First Submitted That Met QC Criteria: February 23, 2023
• First Posted (Actual): February 24, 2023

Study Record Updates

• Last Update Posted (Actual): June 2, 2023
• Last Update Submitted That Met QC Criteria: June 1, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protein Kinase Inhibitors; Lazertinib
• Other Study ID Numbers: CR109315; 73841937NSC1009 (Other Identifier: Janssen Research & Development, LLC)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No