A Study of Four Different Oral Tablet Formulations of Lazertinib (JNJ-73841937) in Healthy Adult Participants
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Intervention Sequence: ADBC 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. |
Drug: Lazertinib
Lazertinib will be administered orally.
Other Names:
|
| Experimental: Intervention Sequence: BACD 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. |
Drug: Lazertinib
Lazertinib will be administered orally.
Other Names:
|
| Experimental: Intervention Sequence: CBDA 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. |
Drug: Lazertinib
Lazertinib will be administered orally.
Other Names:
|
| Experimental: Intervention Sequence: DCAB 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. |
Drug: Lazertinib
Lazertinib will be administered orally.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- 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
- 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.
- 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 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.
- 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.
- 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.
Eligibility Criteria
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
-
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
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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
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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
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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
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History of malignancy within 5 years before screening
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Known allergies, hypersensitivity, or intolerance to lazertinib or its excipients
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Participant has a history of clinically significant allergies
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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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Celerion | Tempe | Arizona | United States | 85283 |
Sponsors and Collaborators
- Janssen Research & Development, LLC
Investigators
- Study Director: Janssen Research & Development, LLC Clinical Trail, Janssen Research & Development, LLC
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CR109315
- 73841937NSC1009