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

NCT05076877 | Completed Phase 1 FDA Drug

• 2 other identifiers: CR10908073841937NSC1008
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Number of Participants with Adverse Events (AEs)

  Up to 56 days

• Number of Participants with AEs by Severity

  Up to 56 days

• Number of Participants with Clinically Significant Changes in Laboratory Test Results

  Up to 28 days

• Number of Participants with Clinically Significant Abnormalities in 12-lead Electrocardiograms (ECGs)

  Up to 28 days

• Number of Participants with Clinically Significant Abnormalities in Vital Signs

  Up to 28 days

Study Arms (1)

Lazertinib + Probe Substrates of Midazolam, Rosuvastatin, and Metformin

EXPERIMENTAL

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.

Drug: Lazertinib; Drug: Midazolam; Drug: Rosuvastatin; Drug: Metformin

Interventions

Lazertinib DRUG

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

Also known as: JNJ-73841937, YH25448

Lazertinib + Probe Substrates of Midazolam, Rosuvastatin, and Metformin

Midazolam DRUG

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

Lazertinib + Probe Substrates of Midazolam, Rosuvastatin, and Metformin

Rosuvastatin DRUG

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

Lazertinib + Probe Substrates of Midazolam, Rosuvastatin, and Metformin

Metformin DRUG

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

Lazertinib + Probe Substrates of Midazolam, Rosuvastatin, and Metformin

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (1)

PRA Health Sciences

Salt Lake City, Utah, 84124, United States

Location

MeSH Terms

Interventions

lazertinib; Midazolam; Rosuvastatin Calcium; Metformin

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Sulfonamides; Amides; Organic Chemicals; Fluorobenzenes; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrimidines; Heterocyclic Compounds, 1-Ring; Biguanides; Guanidines; Amidines

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2021
• First Posted: October 13, 2021
• Study Start: September 17, 2021
• Primary Completion: February 10, 2022
• Study Completion: February 10, 2022
• Last Updated: June 27, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will share

Locations

US (1)