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

NCT05076877 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2022-06-27

No results posted yet for this study

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

Interventions

DRUG

Lazertinib

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

DRUG

Midazolam

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

DRUG

Rosuvastatin

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

DRUG

Metformin

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

Sponsors & Collaborators

  • Janssen Research & Development, LLC

    lead INDUSTRY

Principal Investigators

  • Janssen Research & Development, LLC Clinical Trial · Janssen Research & Development, LLC

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-09-17
Primary Completion
2022-02-10
Completion
2022-02-10
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05076877 on ClinicalTrials.gov