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

NCT ID: NCT05076877

Last Updated: 2022-06-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-17
• Study Completion Date: 2022-02-10

Brief 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.

Conditions

Healthy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Lazertinib + Probe Substrates of Midazolam, Rosuvastatin, and Metformin

Participants will receive a single oral dose of probe substrates of midazolam, rosuvastatin, and metformin on Day 1 under fasted conditions followed by a single oral dose of lazertinib under fed conditions from Day 5 to Day 14 except Day 13 which is under fasted conditions and co-administered with probe substrates under fasted conditions on Day 13.

Group Type: EXPERIMENTAL

Lazertinib

Intervention Type: DRUG

Lazertinib tablets will be administered orally, alone or in combination with probe substrates.

Midazolam

Intervention Type: DRUG

Midazolam (cytochrome P450 3A4 \[CYP3A4\] substrate) will be administered orally as a syrup as a part of probe substrates.

Rosuvastatin

Intervention Type: DRUG

Rosuvastatin (breast cancer resistant protein \[BCRP\] substrate) tablet will be administered orally as a part of probe substrates.

Metformin

Intervention Type: DRUG

Metformin (organic cation transporter 1 \[OCT1\] substrate) will be administered orally as a syrup as a part of probe substrates.

Interventions

Lazertinib

Lazertinib tablets will be administered orally, alone or in combination with probe substrates.

Intervention Type: DRUG

Midazolam

Midazolam (cytochrome P450 3A4 \[CYP3A4\] substrate) will be administered orally as a syrup as a part of probe substrates.

Intervention Type: DRUG

Rosuvastatin

Rosuvastatin (breast cancer resistant protein \[BCRP\] substrate) tablet will be administered orally as a part of probe substrates.

Intervention Type: DRUG

Metformin

Metformin (organic cation transporter 1 \[OCT1\] substrate) will be administered orally as a syrup as a part of probe substrates.

Intervention Type: DRUG

Other Intervention Names

JNJ-73841937; YH25448

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Janssen Research & Development, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen Research & Development, LLC Clinical Trial

Role: STUDY_DIRECTOR

Janssen Research & Development, LLC

Locations

PRA Health Sciences

Salt Lake City, Utah, United States

Countries

United States

Other Identifiers

73841937NSC1008

Identifier Type: OTHER

Identifier Source: secondary_id

CR109080

Identifier Type: -

Identifier Source: org_study_id