A Study of Four Different Oral Tablet Formulations of Lazertinib (JNJ-73841937) in Healthy Adult Participants
- Registration Number
- NCT05742594
- Lead Sponsor
- Janssen Research & Development, LLC
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 64
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Intervention Sequence: ADBC Lazertinib Participants will receive intervention A (lazertinib reference formulation) on Day 1 of intervention Period 1, followed by intervention D (lazertinib test formulation) on Day 1 of intervention Period 2, followed by intervention B (lazertinib test formulation) on Day 1 of intervention Period 3 followed by intervention C (lazertinib test formulation) on Day 1 of Intervention Period 4. There will be a wash-out period of at least 14 days and up to 21 days between each intervention period. Intervention Sequence: DCAB Lazertinib Participants will receive intervention D (lazertinib test formulation) on Day 1 of intervention Period 1, followed by intervention C (lazertinib test formulation) on Day 1 of intervention Period 2, followed by intervention A (lazertinib reference formulation) on Day 1 of intervention Period 3 followed by intervention B (lazertinib test formulation) on Day 1 of intervention Period 4. There will be a wash-out period of at least 14 days and up to 21 days between each intervention period. Intervention Sequence: BACD Lazertinib Participants will receive intervention B (lazertinib test formulation) on Day 1 of intervention Period 1, followed by intervention A (lazertinib reference formulation) on Day 1 of intervention Period 2, followed by intervention C (lazertinib test formulation) on Day 1 of intervention Period 3 followed by intervention D (lazertinib test formulation) on Day 1 of intervention Period 4. There will be a wash-out period of at least 14 days and up to 21 days between each intervention period. Intervention Sequence: CBDA Lazertinib Participants will receive intervention C (lazertinib test formulation) on Day 1 of intervention Period 1, followed by intervention B (lazertinib test formulation) on Day 1 of intervention Period 2, followed by intervention D (lazertinib test formulation) on Day 1 of intervention Period 3 followed by intervention A (lazertinib reference formulation) on Day 1 of intervention Period 4. There will be a wash-out period of at least 14 days and up to 21 days between each intervention period.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.
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.
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.
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.
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 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 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 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 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.
Trial Locations
- Locations (1)
Celerion
🇺🇸Tempe, Arizona, United States