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

Part of paid clinical trials in Tempe, Arizona.

Sponsor
Janssen Research & Development, LLC
Study ID
NCT04410094
Phase
PHASE1
Status
Completed

Conditions

  • Healthy

Eligibility Criteria

Sex
ALL
Age
18 Years - 60 Years
Healthy Volunteers
Accepted

Interventions

  • Lazertinib — DRUG
    Lazertinib tablets will be administered orally.
  • Itraconazole — DRUG
    Itraconazole capsules will be administered orally.
  • Rifampin — DRUG
    Rifampin capsules will be administered orally.

Study Details

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.

Key Dates

Start date
Sep 14, 2020
Status verified
Feb 2021
Primary completion
Dec 30, 2020
Completion
Feb 2, 2021

Study Design

Enrollment
32 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Experimental: Cohort 1: Lazertinib plus Itraconazole
    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.
  • Experimental: Cohort 2: Lazertinib plus Rifampin
    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.

Primary Outcome Measure

Cohort 1 and 2: Maximum Plasma Concentration (Cmax) of Lazertinib [ Time Frame: Predose up to 120 hours post dose ]

Locations (1)

FacilityCityStateZIPSite coordinators
CelerionTempeArizona85283-

Find similar trials in Tempe, AZ

By research site
Celerion· Tempe, AZ

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