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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05742594
• Other study ID #: CR109315
• Secondary ID: 73841937NSC1009
• Status: Completed
• Phase: Phase 1
• Start date: January 3, 2023
• Est. completion date: April 3, 2023

Study information

• Verified date: June 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 bioequivalence of four different lazertinib oral tablet formulations in healthy adult participants under fasted condition.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: April 3, 2023
• Est. primary completion date: March 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 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

• 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

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• Lazertinib
Lazertinib will be administered orally.

Locations

Country	Name	City	State
United States	Celerion	Tempe	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Research & Development, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
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 14 weeks
Secondary	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
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 clinical chemistry) will be reported.	Up to 14 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 14 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/heart rate, respiratory rate, and blood pressure) will be reported.	Up to 14 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 14 weeks