NCT05076877

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

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)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Janssen Research & Development, LLC · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2021-09-17
• Primary completion: 2022-02-10
• Completion: 2022-02-10
• First posted: 2021-10-13
• Last updated: 2022-06-27

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study