A Study of Lazertinib (JNJ-73841937) Tablet in Healthy Adult Participants

NCT05896683 | Completed Phase 1

• 3 other identifiers: CR10931473841937NSC10102022-502814-99-00
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (4)

• Part 1: Maximum Observed Plasma Concentration (Cmax) of Lazertinib

  Cmax is defined as maximum observed plasma concentration of lazertinib.

  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.

  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.

  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.

  Pre dose up to 72 hours post dose on Day 1

Secondary Outcomes (7)

• Number of Participants With Adverse Events (AEs)

  Up to 8 Weeks

• Number of Participants With Serious Adverse Events (SAEs)

  Up to 8 Weeks

• Number of Participants With AEs by Severity

  Up to 8 Weeks

• Number of Participants With Change From Baseline in Clinical Laboratory Test Values

  Up to 8 Weeks

• Number of Participants With Change From Baseline in 12-lead Electrocardiograms (ECGs)

  Up to 8 Weeks

Study Arms (4)

Part 1: Sequence AB

EXPERIMENTAL

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

Part 1: Sequence BA

EXPERIMENTAL

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

Part 2: Sequence CD

EXPERIMENTAL

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

Part 2: Sequence DC

EXPERIMENTAL

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

Interventions

Lazertinib DRUG

Lazertinib will be administered orally.

Also known as: JNJ-73841937

Part 1: Sequence AB; Part 1: Sequence BA; Part 2: Sequence CD; Part 2: Sequence DC

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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 in Intervention Period 1
• Body weight not less than 50.0 kilograms (kgs) and body mass index (BMI, weight/height\^2) within the range 19.0-30.0 kg/m\^2 (inclusive) at screening
• All female participants must have a negative highly sensitive serum beta-human chorionic gonadotropin (beta-HCG) test at screening and a negative urine pregnancy test 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 ICF indicating that the participant understands the purpose of, and procedures required for, the study and is willing to participate in the study

You may not qualify if:

• History of or current clinically significant medical illness including (but not limited to) cardiac arrhythmias or other cardiac disease, hematologic disease, coagulation disorders (including any abnormal bleeding or blood dyscrasias), lipid abnormalities, significant pulmonary disease, including bronchospastic respiratory disease and interstitial lung disease, diabetes mellitus (with the exception of history of gestational diabetes), hepatic insufficiency, inflammation bowel disease/Crohn's disease, thyroid disease, neurologic or psychiatric disease, infection, or any other illness that the investigator considers should exclude the participant or that could interfere with the interpretation of the study results
• 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
• Use of any prescription or nonprescription medication (including vitamins and herbal supplements), except for paracetamol, ibuprofen, and stable hormone replacement therapy (in postmenopausal female participants only) within 14 days before the first dose of study intervention is scheduled until completion of the study
• History of human immunodeficiency virus (HIV) antibody positive, or tests positive for HIV at screening

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (1)

SGS Belgium NV

Edegem, 2650, Belgium

Location

MeSH Terms

Interventions

lazertinib

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 1, 2023
• First Posted: June 9, 2023
• Study Start: May 30, 2023
• Primary Completion: September 1, 2023
• Study Completion: September 1, 2023
• Last Updated: February 3, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share

Locations

BE (1)