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

Part of paid clinical trials in Salt Lake City, Utah.

Sponsor
Janssen Research & Development, LLC
Study ID
NCT05076877
Phase
PHASE1
Status
Completed

Conditions

  • Healthy

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • Lazertinib — DRUG
    Lazertinib tablets will be administered orally, alone or in combination with probe substrates.
  • Midazolam — DRUG
    Midazolam (cytochrome P450 3A4 \[CYP3A4\] substrate) will be administered orally as a syrup as a part of probe substrates.
  • Rosuvastatin — DRUG
    Rosuvastatin (breast cancer resistant protein \[BCRP\] substrate) tablet will be administered orally as a part of probe substrates.
  • Metformin — DRUG
    Metformin (organic cation transporter 1 \[OCT1\] substrate) will be administered orally as a syrup as a part of probe substrates.

Study Details

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.

Key Dates

Start date
Sep 17, 2021
Status verified
Jun 2022
Primary completion
Feb 10, 2022
Completion
Feb 10, 2022

Study Design

Enrollment
20 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: 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.

Primary Outcome Measure

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 [ Time Frame: Predose up to 12 hours postdose (Days 1 and 13) ]

Locations (1)

FacilityCityStateZIPSite coordinators
PRA Health SciencesSalt Lake CityUtah84124-

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By research site
PRA Health Sciences· Salt Lake City, UT

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