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

NCT ID: NCT05896683

Last Updated: 2025-02-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-30
• Study Completion Date: 2023-09-01

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Part 1: Sequence AB

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.

Group Type: EXPERIMENTAL

Lazertinib

Intervention Type: DRUG

Lazertinib will be administered orally.

Part 1: Sequence BA

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.

Group Type: EXPERIMENTAL

Lazertinib

Intervention Type: DRUG

Lazertinib will be administered orally.

Part 2: Sequence CD

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.

Group Type: EXPERIMENTAL

Lazertinib

Intervention Type: DRUG

Lazertinib will be administered orally.

Part 2: Sequence DC

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.

Group Type: EXPERIMENTAL

Lazertinib

Intervention Type: DRUG

Lazertinib will be administered orally.

Interventions

Lazertinib

Lazertinib will be administered orally.

Intervention Type: DRUG

Other Intervention Names

JNJ-73841937

Eligibility Criteria

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 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Janssen Research & Development, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen Research & Development, LLC Clinical Trial

Role: STUDY_DIRECTOR

Janssen Research & Development, LLC

Locations

SGS Belgium NV

Edegem, , Belgium

Countries

Belgium

Other Identifiers

73841937NSC1010

Identifier Type: OTHER

Identifier Source: secondary_id

2022-502814-99-00

Identifier Type: REGISTRY

Identifier Source: secondary_id

CR109314

Identifier Type: -

Identifier Source: org_study_id