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| ID | Type | Description | Link |
|---|---|---|---|
| 2021-001950-71 | EudraCT Number | ||
| 73841937NSC1007 | Other Identifier | Janssen Research & Development, LLC |
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The purpose of this study is to evaluate the pharmacokinetics (PK) of a single oral dose of lazertinib in participants with impaired hepatic function when compared with healthy participants with normal hepatic function, under fed conditions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A: Group 1: Moderate Hepatic Impairment | Experimental | Participants with moderate hepatic impairment will receive a single oral dose of lazertinib. |
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| Part A: Group 2: Normal Hepatic Function | Active Comparator | Participants with normal hepatic function who qualify for the control group will receive a single oral dose of lazertinib. |
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| Part B: Group 3 (Optional): Mild Hepatic Impairment | Experimental | Participants with mild hepatic impairment will receive a single oral dose of lazertinib. |
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| Part B: Group 4 (Optional): Severe Hepatic Impairment | Experimental | Participants with severe hepatic impairment will receive a single oral dose of lazertinib. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lazertinib | Drug | Lazertinib tablet will be administered orally. |
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| Measure | Description | Time Frame |
|---|---|---|
| Plasma Concentrations of Lazertinib | Plasma concentrations of lazertinib will be analyzed using a validated, specific, and sensitive method to assess the effect of hepatic impairment on the pharmacokinetic of lazertinib. | Predose up to 312 hour postdose (up to Day 14) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability | 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 49 days |
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Inclusion Criteria:
All Participants:
Healthy Participants with normal hepatic function:
Participants with hepatic impairment:
Exclusion Criteria:
All Participants:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CRS Clinical Research Services Kiel GmbH | Kiel | 24105 | Germany | |||
| APEX GmbH |
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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|
| München |
| 81241 |
| Germany |