A Study to Assess the Effects of Itraconazole and Rifampin on Lazertinib in Healthy Adult Participants

NCT04410094 | Completed Phase 1 FDA Drug

• 2 other identifiers: CR10879973841937NSC1003
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the effects of multiple doses of strong cytochrome P450 (CYP) 3A4 inhibitor itraconazole and strong CYP3A4 inducer rifampin on the single dose pharmacokinetics (PK) of lazertinib in healthy adult participants.

Conditions

Healthy

Outcome Measures

Primary Outcomes (5)

• Cohort 1 and 2: Maximum Plasma Concentration (Cmax) of Lazertinib

  Cmax is defined as maximum plasma concentration.

  Predose up to 120 hours post dose

• Cohort 1 and 2: Area Under the Plasma Concentration-time Curve from Time 0 to 120 Hours (AUC [0-120h]) of Lazertinib

  AUC (0-120h) is defined as area under the plasma concentration-time curve from time 0 to 120 hours postdose.

  Predose up to 120 hours post dose

• Cohort 1 and 2: Area Under the Plasma Concentration-time Curve from Time Zero to Time of Last Quantifiable Timepoint (AUC [0-last]) of Lazertinib

  AUC (0-last) is defined as area under the plasma concentration-time curve from time 0 to time of last quantifiable timepoint.

  Predose up to 120 hours post dose

• Cohort 1 and 2: Area Under the Plasma Concentration-time Curve from Time Zero to Infinity (AUC [0-inf]) of Lazertinib

  AUC (0-inf) is defined as area under the plasma concentration-time curve from time 0 to infinity, calculated as the sum of AUC(0-last)+C(last)/ lambda(z), where C(last) is the last observed measurable (non-below limit of quantification) concentration.

  Predose up to 120 hours post dose

• Cohort 1 and 2: Percentage of Area Under the Plasma Concentration from time Zero to Infinite time obtained by Extrapolation (%AUC [0-inf],ex) of Lazertinib

  %AUC (0-inf),ex is defined as percentage of area under the plasma concentration from time zero to infinite time obtained by extrapolation, calculated as (AUC \[0-infinity\] minus AUC \[0-last\]/AUC \[0-infinity\])\*100.

  Predose up to 120 hours post dose

Secondary Outcomes (1)

• Cohort 1 and Cohort 2: Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability

  Up to 65 days (Cohort 1) and up to 70 days (Cohort 2)

Study Arms (2)

Cohort 1: Lazertinib plus Itraconazole

EXPERIMENTAL

Participants will receive a single oral dose of lazertinib tablets in Treatment Period 1 followed by itraconazole capsules orally along with a single oral dose of lazertinib tablet in Treatment Period 2.

Drug: Lazertinib; Drug: Itraconazole

Cohort 2: Lazertinib plus Rifampin

EXPERIMENTAL

Participants will receive a single oral dose of lazertinib tablets in Treatment Period 1 followed by rifampin capsules orally along with a single oral dose of lazertinib tablet in Treatment Period 2.

Drug: Lazertinib; Drug: Rifampin

Interventions

Lazertinib DRUG

Lazertinib tablets will be administered orally.

Also known as: JNJ-73841937; YH25448

Cohort 1: Lazertinib plus Itraconazole; Cohort 2: Lazertinib plus Rifampin

Itraconazole DRUG

Itraconazole capsules will be administered orally.

Cohort 1: Lazertinib plus Itraconazole

Rifampin DRUG

Rifampin capsules will be administered orally.

Cohort 2: Lazertinib plus Rifampin

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• A woman must not be of childbearing potential and must have a negative serum beta-human chorionic gonadotropin (Beta HCG) pregnancy test at screening
• Hormone replacement therapy (if applicable) must have been discontinued at least 28 days prior to the first dose of study drug (Cohort 2 only)
• Participants must have a body mass index (BMI) between 18.0 and 32.0 kilogram per meter square (kg/m\^2, inclusive (BMI = weight/height\^2), and body weight not less than 50 kg at screening
• Participants must be healthy based on physical examination, medical history, and vital signs (pulse and body temperature), performed at screening
• Male participants must agree to use an adequate contraception method

You may not qualify if:

• History of or current clinically significant medical illness that the investigator considers should exclude the participant or that could interfere with the interpretation of the study results
• History of infection suspected or confirmed to be related to Coronavirus disease 2019 (COVID-19) within 4 weeks before intake of study drug
• Participant has known allergies, hypersensitivity, or intolerance to lazertinib or its excipients or to itraconazole and rifampin
• Participant has contraindications to the use itraconazole and rifampin per local prescribing information
• Use of any cytochrome P450 (CYP) 3A4 inhibitors or inducers (other than per-protocol itraconazole/rifampin administration) within 4 weeks before the first dose of the study drug is scheduled until completion of the study

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (1)

Celerion

Tempe, Arizona, 85283, United States

Location

MeSH Terms

Interventions

lazertinib; Itraconazole; Rifampin

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperazines; Rifamycins; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Lactams, Macrocyclic; Macrocyclic Compounds; Polycyclic Compounds

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2020
• First Posted: June 1, 2020
• Study Start: September 14, 2020
• Primary Completion: December 30, 2020
• Study Completion: February 2, 2021
• Last Updated: March 1, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will share

Locations

US (1)