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Completed

NCT Number: NCT05742594

A Study of Four Different Oral Tablet Formulations of Lazertinib (JNJ-73841937) in Healthy Adult Participants

The purpose of this study is to assess the bioequivalence of four different lazertinib oral tablet formulations in healthy adult participants under fasted condition.

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Key information

Conditions

Healthy

Age range

18 year–55 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

  • Healthy on the basis of physical examination, medical history (at screening only), vital signs, and 12-lead electrocardiogram (ECG) performed at screening and at admission to the study site
  • All female participants must have a negative highly sensitive serum Beta-human chorionic gonadotropin (Beta-HCG) at screening and on Day -1 of Intervention Period 1
  • A male participant must agree not to donate sperm for the purpose of reproduction during the study and for a minimum of 6 months after receiving the last dose of study intervention
  • Must sign an informed consent form (ICF) indicating that the participant understands the purpose of, and procedures required for, the study and is willing to participate in the study
  • Female participants must be postmenopausal or surgically sterile

Exclusion criteria

  • History of stomach or intestinal surgery or resection, including cholecystectomy, that would potentially alter absorption or excretion of orally administered drugs
  • History of malignancy within 5 years before screening
  • Known allergies, hypersensitivity, or intolerance to lazertinib or its excipients
  • Participant has a history of clinically significant allergies
  • Had major surgery, (for example, requiring general anesthesia) within 8 weeks before screening, or will not have fully recovered from the surgery, or has surgery planned during the time the participant is expected to participate in the study or within 4 weeks after the last dose of study intervention administration

Treatment and study plan

Lazertinib

Drug

Lazertinib will be administered orally.

Other names: JNJ-73841937

Primary outcomes

  1. Interventions A, B and C: Maximum Observed Plasma Concentration (Cmax) of Lazertinib

    Time frame: Pre dose up to 168 hours post dose

    Cmax is defined as maximum observed plasma concentration.

  2. Interventions A, B and C: Area Under the Plasma Concentration-time Curve from Time 0 to 72 Hours (h) (AUC[0-72h]) of Lazertinib

    Time frame: Pre dose up to 168 hours post dose

    AUC (0-72h) is the area under the plasma concentration-time curve from time 0 to 72 hours.

Secondary outcomes

  1. Interventions A and D: Maximum Observed Plasma Concentration (Cmax) of Lazertinib

    Time frame: Pre dose up to 168 hours post dose

    Cmax is defined as maximum observed plasma concentration.

  2. Interventions A and D: Area Under the Plasma Concentration-time Curve from Time of 0 to 72 Hours [AUC (0-72h)] of Lazertinib

    Time frame: Pre dose up to 168 hours post dose

    AUC (0-72h) is the area under the plasma concentration-time curve from time 0 to 72 hours.

  3. Number of Participants With Adverse Events (AEs)

    Time frame: Up to 14 weeks

    AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.

  4. Number of Participants With Serious Adverse Events (SAEs)

    Time frame: Up to 14 weeks

    A SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.

  5. Number of Participants With AEs by Severity

    Time frame: Up to 14 weeks

    Number of participants with AEs by severity will be reported. Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. Severity scale ranges from grade 1 (mild) to grade 5 (death). Grade 1= mild, Grade 2= moderate, Grade 3= severe, Grade 4= life-threatening and Grade 5= death related to adverse event.

  6. Number of Participants With Change From Baseline in Clinical Laboratory Test Values

    Time frame: Up to 14 weeks

    Number of participants with change from baseline in clinical laboratory test values (including hematology and clinical chemistry) will be reported.

  7. Number of Participants With Change From Baseline in 12-lead Electrocardiograms (ECGs)

    Time frame: Up to 14 weeks

    Number of participants with change from baseline in 12-lead ECGs will be reported.

  8. Number of Participants With Change From Baseline in Vital Signs

    Time frame: Up to 14 weeks

    Number of participants with change from baselines in vital signs (including temperature [oral], pulse/heart rate, respiratory rate, and blood pressure) will be reported.

  9. Number of Participants With Change From Baseline in Physical Examination

    Time frame: Up to 14 weeks

    Number of participants with change from baseline in physical examination (including height and body weight) will be reported.

Sponsors and collaborators

Lead sponsor

Janssen Research & Development, LLC

Industry

Registry information

Official study title

A Phase 1, Open-label, Randomized, 4-Way Crossover Pivotal Study to Assess the Bioequivalence of Four Different Oral Tablet Formulations of Lazertinib (JNJ-73841937) in Healthy Adult Participants

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Feb 24, 2023
Registry last updated
Jun 2, 2023

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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