A Study of Four Different Oral Tablet Formulations of Lazertinib (JNJ-73841937) in Healthy Adult Participants
Completed · Phase 1
Conditions studied: Healthy
In brief
The purpose of this study is to assess the bioequivalence of four different lazertinib oral tablet formulations in healthy adult participants under fasted condition.
Key facts
- Study ID
- NCT05742594
- Run by
- Janssen Research & Development, LLC
- People needed
- 64
- Starts
- 2023-01-03
- Expected to finish
- 2023-04-03
- Last updated by the study team
- 2023-06-02
Who can join
Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Celerion — Tempe, Arizona, United States
Full record on ClinicalTrials.gov
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