A Study of Lazertinib (JNJ-73841937) in Healthy Participants

Healthy Clinical Trial

Official title:

A Phase 1, Open-label, Study in Healthy Participants to Evaluate the Effect of Steady State Concentrations of Lazertinib (JNJ-73841937) on the Single-dose Pharmacokinetics of Probe Substrates (Midazolam, Rosuvastatin, and Metformin)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05076877
• Other study ID #: CR109080
• Secondary ID: 73841937NSC1008
• Status: Completed
• Phase: Phase 1
• Start date: September 17, 2021
• Est. completion date: February 10, 2022

Study information

• Verified date: June 2022
• Source: Janssen Research & Development, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the effect of steady-state concentrations of lazertinib on the single-dose pharmacokinetics (PK) of probe substrates (midazolam, rosuvastatin, and metformin) in healthy adult participants.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: February 10, 2022
• Est. primary completion date: February 10, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Healthy on the basis of medical history at screening only, and physical examination, vital signs, and 12-lead electrocardiogram (ECG) performed at screening and at admission to the study center
• Healthy on the basis of clinical laboratory tests performed at screening and at admission to the study center.
• A woman who is considered surgically sterile but not postmenopausal, must have a negative highly sensitive serum (beta-human chorionic gonadotropin [beta-hCG]) at screening and a negative urine pregnancy test on Study Day 1. (exemptions: pregnancy test not required in female participants with prior hysterectomy or prior bilateral oophorectomy)
• Male participants must agree to use an adequate contraception method as deemed appropriate by the investigator
• Non-smoker or not using tobacco containing products for at least 6 months before first study drug administration and test negative for cotinine at screening and Study Day 1

Exclusion Criteria:

• History of malignancy within 5 years before screening (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or malignancy, that in the opinion of the investigator, with written concurrence with the sponsor's medical monitor is considered cured with minimal risk of recurrence)
• History of suspected or confirmed coronavirus disease 2019 within 4 weeks before intake of study drug, or tests positive for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) at admission to the study site
• Known allergies, hypersensitivity, or intolerance to lazertinib or its excipients or probe substrates
• Taken any disallowed therapies, concomitant therapy before the planned first dose of study drug
• Had major surgery, (example, requiring general anesthesia) within 8 weeks before screening, or will not have fully recovered from 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 drug administration

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• Lazertinib
Lazertinib tablets will be administered orally, alone or in combination with probe substrates.
• Midazolam
Midazolam (cytochrome P450 3A4 [CYP3A4] substrate) will be administered orally as a syrup as a part of probe substrates.
• Rosuvastatin
Rosuvastatin (breast cancer resistant protein [BCRP] substrate) tablet will be administered orally as a part of probe substrates.
• Metformin
Metformin (organic cation transporter 1 [OCT1] substrate) will be administered orally as a syrup as a part of probe substrates.

Locations

Country	Name	City	State
United States	PRA Health Sciences	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Research & Development, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma Concentration of Probe Substrates (Midazolam, Rosuvastatin, and Metformin) Co-administered with Lazertinib (Day 13) as Test Versus Plasma Concentration of Probe Substrates Administered Alone (Day 1) as Reference	Plasma samples will be analyzed to determine concentrations of midazolam and its metabolite 1-OH-midazolam, rosuvastatin, metformin, or lazertinib using a validated, specific, and sensitive method on Day 1 versus Day 13 as a part of drug-drug interaction (DDI) assessment.	Predose up to 12 hours postdose (Days 1 and 13)
Secondary	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 56 days
Secondary	Number of Participants with AEs by Severity	Number of participants with AEs by severity will be reported. AE severity is a clinical determination of the intensity of an AE and is assessed by using the standard grades as follows: Grade 1= mild, Grade 2= moderate, Grade 3= severe, Grade 4= life-threatening and Grade 5= death related to AE.	Up to 56 days
Secondary	Number of Participants with Clinically Significant Changes in Laboratory Test Results	Number of participants with change in clinical laboratory test results (including hematology and serum chemistry) will be reported.	Up to 28 days
Secondary	Number of Participants with Clinically Significant Abnormalities in 12-lead Electrocardiograms (ECGs)	Number of participants with clinically significant abnormalities in ECGs will be reported.	Up to 28 days
Secondary	Number of Participants with Clinically Significant Abnormalities in Vital Signs	Number of participants with clinically significant abnormalities in vital signs (including temperature [oral], pulse rate, and blood pressure) will be reported.	Up to 28 days
Secondary	Number of Participants with Clinically Significant Abnormalities in Physical Examination	Number of participants with clinically significant abnormalities in physical examination (including height and body weight) will be reported.	Up to 28 days
Secondary	Plasma Concentrations of Lazertinib at steady-state	Plasma concentration of lazertinib at steady-state will be assessed.	Predose on Day 7, 9, 11, 13, and 14
Secondary	Plasma Concentrations of Lazertinib Following Repeat Dosing for 10 Days	Plasma concentration of lazertinib following repeat dosing for 10 days will be assessed.	Day 14, 15, 16, 17, 21, and 28