Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 73841937NSC1010 | Other Identifier | Janssen Research & Development, LLC | |
| 2022-502814-99-00 | Registry Identifier | EUCT number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to assess the extent of availability of drug to the body of four different lazertinib tablet formulations at a single oral dose under fasted conditions in healthy adult participants.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1: Sequence AB | Experimental | Participants will receive intervention A (lazertinib reference formulation) on Day 1 of intervention period 1. After washout period of 14 to 21 days, participants will receive intervention B (lazertinib test formulation) on Day 1 of intervention period 2. |
|
| Part 1: Sequence BA | Experimental | Participants will receive intervention B (lazertinib test formulation) on Day 1 of intervention period 1. After washout period of 14 to 21 days, participants will receive intervention A (lazertinib reference formulation) on Day 1 of intervention period 2. |
|
| Part 2: Sequence CD | Experimental | Participants will receive Intervention C (lazertinib reference formulation) on Day 1 of intervention period 1. After washout period of 14 to 21 days, participants will receive intervention D (lazertinib test formulation) on Day 1 of intervention period 2. |
|
| Part 2: Sequence DC | Experimental | Participants will receive intervention D (lazertinib test formulation) on Day 1 of intervention period 1. After washout period of 14 to 21 days, participants will receive intervention C (lazertinib reference formulation) on Day 1 of intervention period 2. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lazertinib | Drug | Lazertinib will be administered orally. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Part 1: Maximum Observed Plasma Concentration (Cmax) of Lazertinib | Cmax is defined as maximum observed plasma concentration of lazertinib. | Pre dose up to 168 hours post dose on Day 1 |
| Part 2: Maximum Observed Plasma Concentration (Cmax) of Lazertinib | Cmax is defined as maximum observed plasma concentration of lazertinib. | Pre dose up to 168 hours post dose on Day 1 |
| Part 1: 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 72 hours post dose on Day 1 |
| Part 2: Area Under the Plasma Concentration-time Curve from Time 0 to 72h (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 72 hours post dose on Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events (AEs) | An 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 intervention. | Up to 8 Weeks |
| Number of Participants With Serious Adverse Events (SAEs) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SGS Belgium NV | Edegem | 2650 | Belgium |
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
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| C000707992 | lazertinib |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
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 8 Weeks |
| Number of Participants With AEs by Severity | An AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. 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 to 5, where Grade 1= mild, Grade 2= moderate, Grade 3= severe, Grade 4= life-threatening and Grade 5= death related to adverse event. | Up to 8 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 serum chemistry) will be reported. | Up to 8 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 8 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 rate, and blood pressure) will be reported. | Up to 8 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 8 Weeks |