Healthy
Conditions
Brief 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.
Interventions
DRUGLazertinib
Lazertinib will be administered orally.
Sponsors
Janssen Research & Development, LLC
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Interventions A, B and C: Maximum Observed Plasma Concentration (Cmax) of Lazertinib | Pre dose up to 168 hours post dose | Cmax is defined as maximum observed plasma concentration. |
| Interventions A, B and C: Area Under the Plasma Concentration-time Curve from Time 0 to 72 Hours (h) (AUC[0-72h]) of Lazertinib | Pre dose up to 168 hours post dose | AUC (0-72h) is the area under the plasma concentration-time curve from time 0 to 72 hours. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adverse Events (AEs) | Up to 14 weeks | 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. |
| Number of Participants With Serious Adverse Events (SAEs) | Up to 14 weeks | 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. |
| Number of Participants With AEs by Severity | Up to 14 weeks | 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. |
| Interventions A and D: Maximum Observed Plasma Concentration (Cmax) of Lazertinib | Pre dose up to 168 hours post dose | Cmax is defined as maximum observed plasma concentration. |
| Number of Participants With Change From Baseline in 12-lead Electrocardiograms (ECGs) | Up to 14 weeks | Number of participants with change from baseline in 12-lead ECGs will be reported. |
| Number of Participants With Change From Baseline in Vital Signs | Up to 14 weeks | Number of participants with change from baselines in vital signs (including temperature \[oral\], pulse/heart rate, respiratory rate, and blood pressure) will be reported. |
| Number of Participants With Change From Baseline in Physical Examination | Up to 14 weeks | Number of participants with change from baseline in physical examination (including height and body weight) will be reported. |
| Number of Participants With Change From Baseline in Clinical Laboratory Test Values | Up to 14 weeks | Number of participants with change from baseline in clinical laboratory test values (including hematology and clinical chemistry) will be reported. |
| Interventions A and D: Area Under the Plasma Concentration-time Curve from Time of 0 to 72 Hours [AUC (0-72h)] of Lazertinib | Pre dose up to 168 hours post dose | AUC (0-72h) is the area under the plasma concentration-time curve from time 0 to 72 hours. |
Countries
United States
Outcome results
None listed