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| ID | Type | Description | Link |
|---|---|---|---|
| 73841937NSC1009 | Other Identifier | Janssen Research & Development, LLC |
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The purpose of this study is to assess the bioequivalence of four different lazertinib oral tablet formulations in healthy adult participants under fasted condition.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Sequence: ADBC | Experimental | 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. |
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| Intervention Sequence: BACD | Experimental | 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. |
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| Intervention Sequence: CBDA | Experimental | 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. |
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| Intervention Sequence: DCAB |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lazertinib | Drug | Lazertinib will be administered orally. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Interventions A and D: Area Under the Plasma Concentration-time Curve from Time of 0 to 72 Hours [AUC (0-72h)] of Lazertinib |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Research & Development, LLC Clinical Trail | Janssen Research & Development, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Celerion | Tempe | Arizona | 85283 | United States |
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
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| ID | Term |
|---|---|
| C000707992 | lazertinib |
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| Experimental |
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. |
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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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |