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

Sponsor
Janssen Research & Development, LLC (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05076877
Collaborator
(none)
20
Enrollment
1
Location
1
Arm
3.4
Anticipated Duration (Months)
5.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or DiseaseIntervention/TreatmentPhase
Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
A Phase 1, Open-label, Study in Healthy Participants to Evaluate the Effect of Steady State Concentrations of Lazertinib (JNJ-73841937) on the Single-dose Pharmacokinetics of Probe Substrates (Midazolam, Rosuvastatin, and Metformin)
Actual Study Start Date :
Sep 17, 2021
Anticipated Primary Completion Date :
Dec 30, 2021
Anticipated Study Completion Date :
Dec 30, 2021

Arms and Interventions

ArmIntervention/Treatment
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.

Drug: Lazertinib
Lazertinib tablets will be administered orally, alone or in combination with probe substrates.
Other Names:
  • JNJ-73841937
  • YH25448
  • Drug: Midazolam
    Midazolam (cytochrome P450 3A4 [CYP3A4] substrate) will be administered orally as a syrup as a part of probe substrates.

    Drug: Rosuvastatin
    Rosuvastatin (breast cancer resistant protein [BCRP] substrate) tablet will be administered orally as a part of probe substrates.

    Drug: Metformin
    Metformin (organic cation transporter 1 [OCT1] substrate) will be administered orally as a syrup as a part of probe substrates.

    Outcome Measures

    Primary Outcome Measures

    1. 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 [Predose up to 12 hours postdose (Days 1 and 13)]

      Plasma samples will be analyzed to determine concentrations of midazolam and its metabolite 1-OH-midazolam, rosuvastatin, metformin, or lazertinib using a validated, specific, and sensitive method on Day 1 versus Day 13 as a part of drug-drug interaction (DDI) assessment.

    Secondary Outcome Measures

    1. Number of Participants with Adverse Events (AEs) [Up to 56 days]

      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.

    2. Number of Participants with AEs by Severity [Up to 56 days]

      Number of participants with AEs by severity will be reported. AE severity is a clinical determination of the intensity of an AE and is assessed by using the standard grades as follows: Grade 1= mild, Grade 2= moderate, Grade 3= severe, Grade 4= life-threatening and Grade 5= death related to AE.

    3. Number of Participants with Clinically Significant Changes in Laboratory Test Results [Up to 28 days]

      Number of participants with change in clinical laboratory test results (including hematology and serum chemistry) will be reported.

    4. Number of Participants with Clinically Significant Abnormalities in 12-lead Electrocardiograms (ECGs) [Up to 28 days]

      Number of participants with clinically significant abnormalities in ECGs will be reported.

    5. Number of Participants with Clinically Significant Abnormalities in Vital Signs [Up to 28 days]

      Number of participants with clinically significant abnormalities in vital signs (including temperature [oral], pulse rate, and blood pressure) will be reported.

    6. Number of Participants with Clinically Significant Abnormalities in Physical Examination [Up to 28 days]

      Number of participants with clinically significant abnormalities in physical examination (including height and body weight) will be reported.

    7. Plasma Concentrations of Lazertinib at steady-state [Predose on Day 7, 9, 11, 13, and 14]

      Plasma concentration of lazertinib at steady-state will be assessed.

    8. Plasma Concentrations of Lazertinib Following Repeat Dosing for 10 Days [Day 14, 15, 16, 17, 21, and 28]

      Plasma concentration of lazertinib following repeat dosing for 10 days will be assessed.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 55 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Healthy on the basis of medical history at screening only, and physical examination, vital signs, and 12-lead electrocardiogram (ECG) performed at screening and at admission to the study center

    • Healthy on the basis of clinical laboratory tests performed at screening and at admission to the study center.

    • A woman who is considered surgically sterile but not postmenopausal, must have a negative highly sensitive serum (beta-human chorionic gonadotropin [beta-hCG]) at screening and a negative urine pregnancy test on Study Day 1. (exemptions: pregnancy test not required in female participants with prior hysterectomy or prior bilateral oophorectomy)

    • Male participants must agree to use an adequate contraception method as deemed appropriate by the investigator

    • Non-smoker or not using tobacco containing products for at least 6 months before first study drug administration and test negative for cotinine at screening and Study Day 1

    Exclusion Criteria:
    • History of malignancy within 5 years before screening (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or malignancy, that in the opinion of the investigator, with written concurrence with the sponsor's medical monitor is considered cured with minimal risk of recurrence)

    • History of suspected or confirmed coronavirus disease 2019 within 4 weeks before intake of study drug, or tests positive for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) at admission to the study site

    • Known allergies, hypersensitivity, or intolerance to lazertinib or its excipients or probe substrates

    • Taken any disallowed therapies, concomitant therapy before the planned first dose of study drug

    • Had major surgery, (example, requiring general anesthesia) within 8 weeks before screening, or will not have fully recovered from 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 drug administration

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1PRA Health SciencesSalt Lake CityUtahUnited States84124

    Sponsors and Collaborators

    • Janssen Research & Development, LLC

    Investigators

    • Study Director: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Janssen Research & Development, LLC
    ClinicalTrials.gov Identifier:
    NCT05076877
    Other Study ID Numbers:
    • CR109080
    • 73841937NSC1008
    First Posted:
    Oct 13, 2021
    Last Update Posted:
    Oct 13, 2021
    Last Verified:
    Oct 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Oct 13, 2021