A Study to Evaluate the Effect of Hepatic Impairment on Lazertinib (JNJ-73841937)
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Part A: Group 1: Moderate Hepatic Impairment Participants with moderate hepatic impairment will receive a single oral dose of lazertinib. |
Drug: Lazertinib
Lazertinib tablet will be administered orally.
Other Names:
|
| Active Comparator: Part A: Group 2: Normal Hepatic Function Participants with normal hepatic function who qualify for the control group will receive a single oral dose of lazertinib. |
Drug: Lazertinib
Lazertinib tablet will be administered orally.
Other Names:
|
| Experimental: Part B: Group 3 (Optional): Mild Hepatic Impairment Participants with mild hepatic impairment will receive a single oral dose of lazertinib. |
Drug: Lazertinib
Lazertinib tablet will be administered orally.
Other Names:
|
| Experimental: Part B: Group 4 (Optional): Severe Hepatic Impairment Participants with severe hepatic impairment will receive a single oral dose of lazertinib. |
Drug: Lazertinib
Lazertinib tablet will be administered orally.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Plasma Concentrations of Lazertinib [Predose up to 312 hour postdose (up to Day 14)]
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.
Secondary Outcome Measures
- Percentage of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability [Up to 49 days]
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.
Eligibility Criteria
Criteria
Inclusion Criteria:
All Participants:
-
Must have a clinically stable hepatic function as confirmed by the serum bilirubin and transaminase levels measured during screening and those measured on Day -1
-
Willing and able to adhere to the prohibitions and restrictions specified in this protocol
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If a woman, must not be of childbearing potential: postmenopausal (amenorrhea for at least 12 months and a serum follicle stimulating hormone within postmenopausal range); or surgically sterile (hysterectomy, bilateral salpingectomy, bilateral oophorectomy, bilateral tubal occlusion/ligation procedure)
Healthy Participants with normal hepatic function:
-
Blood pressure (after the participant is supine for 5 minutes) between 90 and 140 millimeter of mercury (mmHg) systolic for participants less than or equal to (<=) 60 years old and between 90 and 150 mmHg for participants greater than (>) 60 years old, inclusive, and no higher than 90 mmHg diastolic. If blood pressure is out of range, up to 2 repeated assessments are permitted per visit
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Pharmacogenomics: Healthy participants must have matching glutathione S-transferase Mu 1 (GSTM1) genotype (null or non-null GSTM1 genotype) to individual hepatic impairment group participants
Participants with hepatic impairment:
-
A 12-lead electrocardiogram (ECG) consistent with adequate cardiac conduction and function as per judgement by the investigator, including: a) Sinus rhythm; b) Heart rate between 50 and 100 beats per minute (extremes included); c) QTc interval <= 480 milliseconds (ms) (corrected cf. Fridericia; QTcF)
-
Concomitant medications to treat underlying disease states or medical conditions related to hepatic impairment are allowed. Participants must be on a stable dose of medication and/or treatment regimen for at least 2 weeks before dosing as well as during the study
Exclusion Criteria:
All Participants:
-
Participant has known allergies, hypersensitivity, or intolerance to Lazertinib or its excipients
-
Any surgical or medical condition that may alter the absorption, metabolism, or excretion of the study drug (example, gastrectomy, Crohn's disease etc.), with the exception of hepatic impairment
-
Active gall bladder or biliary tract disease (example, acute cholecystitis, symptomatic cholelithiasis)
-
Participant tests positive for human immunodeficiency virus (HIV)-1 or HIV-2 at screening
-
Participant has a lack of adequate venous access
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | CRS Clinical Research Services Kiel GmbH | Kiel | Germany | 24105 | |
| 2 | APEX GmbH | Munchen | Germany | 81241 |
Sponsors and Collaborators
- Janssen Research & Development, LLC
Investigators
- Study Director: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CR109022
- 2021-001950-71
- 73841937NSC1007