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Completed

NCT Number: NCT04410094

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

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.

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Key information

Conditions

Healthy

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Celerion

Tempe, Arizona, 85283, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • A woman must not be of childbearing potential and must have a negative serum beta-human chorionic gonadotropin (Beta HCG) pregnancy test at screening
  • Hormone replacement therapy (if applicable) must have been discontinued at least 28 days prior to the first dose of study drug (Cohort 2 only)
  • Participants must have a body mass index (BMI) between 18.0 and 32.0 kilogram per meter square (kg/m^2, inclusive (BMI = weight/height^2), and body weight not less than 50 kg at screening
  • Participants must be healthy based on physical examination, medical history, and vital signs (pulse and body temperature), performed at screening
  • Male participants must agree to use an adequate contraception method

Exclusion criteria

  • History of or current clinically significant medical illness that the investigator considers should exclude the participant or that could interfere with the interpretation of the study results
  • History of infection suspected or confirmed to be related to Coronavirus disease 2019 (COVID-19) within 4 weeks before intake of study drug
  • Participant has known allergies, hypersensitivity, or intolerance to lazertinib or its excipients or to itraconazole and rifampin
  • Participant has contraindications to the use itraconazole and rifampin per local prescribing information
  • Use of any cytochrome P450 (CYP) 3A4 inhibitors or inducers (other than per-protocol itraconazole/rifampin administration) within 4 weeks before the first dose of the study drug is scheduled until completion of the study

Treatment and study plan

Lazertinib

Drug

Lazertinib tablets will be administered orally.

Other names: JNJ-73841937; YH25448

Itraconazole

Drug

Itraconazole capsules will be administered orally.

Rifampin

Drug

Rifampin capsules will be administered orally.

Primary outcomes

  1. Cohort 1 and 2: Maximum Plasma Concentration (Cmax) of Lazertinib

    Time frame: Predose up to 120 hours post dose

    Cmax is defined as maximum plasma concentration.

  2. Cohort 1 and 2: Area Under the Plasma Concentration-time Curve from Time 0 to 120 Hours (AUC [0-120h]) of Lazertinib

    Time frame: Predose up to 120 hours post dose

    AUC (0-120h) is defined as area under the plasma concentration-time curve from time 0 to 120 hours postdose.

  3. Cohort 1 and 2: Area Under the Plasma Concentration-time Curve from Time Zero to Time of Last Quantifiable Timepoint (AUC [0-last]) of Lazertinib

    Time frame: Predose up to 120 hours post dose

    AUC (0-last) is defined as area under the plasma concentration-time curve from time 0 to time of last quantifiable timepoint.

  4. Cohort 1 and 2: Area Under the Plasma Concentration-time Curve from Time Zero to Infinity (AUC [0-inf]) of Lazertinib

    Time frame: Predose up to 120 hours post dose

    AUC (0-inf) is defined as area under the plasma concentration-time curve from time 0 to infinity, calculated as the sum of AUC(0-last)+C(last)/ lambda(z), where C(last) is the last observed measurable (non-below limit of quantification) concentration.

  5. Cohort 1 and 2: Percentage of Area Under the Plasma Concentration from time Zero to Infinite time obtained by Extrapolation (%AUC [0-inf],ex) of Lazertinib

    Time frame: Predose up to 120 hours post dose

    %AUC (0-inf),ex is defined as percentage of area under the plasma concentration from time zero to infinite time obtained by extrapolation, calculated as (AUC [0-infinity] minus AUC [0-last]/AUC [0-infinity])*100.

Secondary outcomes

  1. Cohort 1 and Cohort 2: Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability

    Time frame: Up to 65 days (Cohort 1) and up to 70 days (Cohort 2)

    An AE is any untoward medical occurrence in a clinical study participant administered a investigational or non investigational medicinal product. An AE does not necessarily have a causal relationship with the treatment.

Sponsors and collaborators

Lead sponsor

Janssen Research & Development, LLC

Industry

Registry information

Official study title

A Phase 1 Open-Label, Fixed-Sequence Drug-Drug Interaction Study to Evaluate the Effects of Steady-state Itraconazole and Rifampin on the Single-dose Pharmacokinetics of Lazertinib Tablets in Healthy Adult Participants

Important dates

Study start
2020
Primary completion
2020
Study completion
2021
First posted
Jun 1, 2020
Registry last updated
Mar 1, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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