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

Healthy Clinical Trial

Official title:

A Phase 1, Open-label, Randomized, 2-Part, 2-Way Crossover Study in Healthy Adult Participants to Assess the Relative Bioavailability of Tablet Formulations of Lazertinib (JNJ-73841937)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05896683
• Other study ID #: CR109314
• Secondary ID: 73841937NSC10102
• Status: Completed
• Phase: Phase 1
• Start date: May 30, 2023
• Est. completion date: September 1, 2023

Study information

• Verified date: September 2023
• Source: Janssen Research & Development, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: September 1, 2023
• Est. primary completion date: September 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• Lazertinib
Lazertinib will be administered orally.

Locations

Country	Name	City	State
Belgium	SGS Belgium NV	Edegem

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Research & Development, LLC

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	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.	Up to 8 Weeks
Secondary	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 8 Weeks
Secondary	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.	Up to 8 Weeks
Secondary	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.	Up to 8 Weeks
Secondary	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 8 Weeks
Secondary	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.	Up to 8 Weeks
Secondary	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 8 Weeks