Clinical trial NCT05076877: A Study of Lazertinib (JNJ-73841937) in Healthy Participants
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2021-10-13
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: Predose up to 12 hours postdose (Days 1 and 13)
Secondary outcomes:
measure: Number of Participants with Adverse Events (AEs)
timeFrame: Up to 56 days
measure: Number of Participants with AEs by Severity
timeFrame: Up to 56 days
measure: Number of Participants with Clinically Significant Changes in Laboratory Test Results
timeFrame: Up to 28 days
measure: Number of Participants with Clinically Significant Abnormalities in 12-lead Electrocardiograms (ECGs)
timeFrame: Up to 28 days
measure: Number of Participants with Clinically Significant Abnormalities in Vital Signs
timeFrame: Up to 28 days
measure: Number of Participants with Clinically Significant Abnormalities in Physical Examination
timeFrame: Up to 28 days
measure: Plasma Concentrations of Lazertinib at steady-state
timeFrame: Predose on Day 7, 9, 11, 13, and 14
measure: Plasma Concentrations of Lazertinib Following Repeat Dosing for 10 Days
timeFrame: Day 14, 15, 16, 17, 21, and 28
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: PRA Health Sciences
state: Utah
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References: