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

Sponsor
Janssen Research & Development, LLC
Study ID
NCT05896683
Phase
PHASE1
Status
Completed

Conditions

  • Healthy

Eligibility Criteria

Sex
ALL
Age
18 Years - 60 Years
Healthy Volunteers
Accepted

Interventions

  • Lazertinib — DRUG
    Lazertinib will be administered orally.

Study Details

The purpose of this study is to assess the extent of availability of drug to the body of four different lazertinib tablet formulations at a single oral dose under fasted conditions in healthy adult participants.

Key Dates

Start date
May 30, 2023
Status verified
Jan 2025
Primary completion
Sep 1, 2023
Completion
Sep 1, 2023

Study Design

Enrollment
72 participants (actual)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Part 1: Sequence AB
    Participants will receive intervention A (lazertinib reference formulation) on Day 1 of intervention period 1. After washout period of 14 to 21 days, participants will receive intervention B (lazertinib test formulation) on Day 1 of intervention period 2.
  • Experimental: Part 1: Sequence BA
    Participants will receive intervention B (lazertinib test formulation) on Day 1 of intervention period 1. After washout period of 14 to 21 days, participants will receive intervention A (lazertinib reference formulation) on Day 1 of intervention period 2.
  • Experimental: Part 2: Sequence CD
    Participants will receive Intervention C (lazertinib reference formulation) on Day 1 of intervention period 1. After washout period of 14 to 21 days, participants will receive intervention D (lazertinib test formulation) on Day 1 of intervention period 2.
  • Experimental: Part 2: Sequence DC
    Participants will receive intervention D (lazertinib test formulation) on Day 1 of intervention period 1. After washout period of 14 to 21 days, participants will receive intervention C (lazertinib reference formulation) on Day 1 of intervention period 2.

Primary Outcome Measure

Part 1: Maximum Observed Plasma Concentration (Cmax) of Lazertinib [ Time Frame: Pre dose up to 168 hours post dose on Day 1 ]

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