Breast Cancer Clinical Trial

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

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.

View Eligibility Criteria

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

Study is for people with:

Breast Cancer

Phase:

Phase 1

Estimated Enrollment:

20

Study ID:

NCT05076877

Recruitment Status:

Completed

Sponsor:

Janssen Research & Development, LLC

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There is 1 Location for this study

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PRA Health Sciences
Salt Lake City Utah, 84124, United States

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Study is for people with:

Breast Cancer

Phase:

Phase 1

Estimated Enrollment:

20

Study ID:

NCT05076877

Recruitment Status:

Completed

Sponsor:


Janssen Research & Development, LLC

How clear is this clinincal trial information?

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