A Study to Assess the Effects of Itraconazole and Rifampin on Lazertinib in Healthy Adult Participants
NCT ID: NCT04410094
Last Updated: 2021-03-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
32 participants
INTERVENTIONAL
2020-09-14
2021-02-02
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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Cohort 1: Lazertinib plus Itraconazole
Participants will receive a single oral dose of lazertinib tablets in Treatment Period 1 followed by itraconazole capsules orally along with a single oral dose of lazertinib tablet in Treatment Period 2.
Lazertinib
Lazertinib tablets will be administered orally.
Itraconazole
Itraconazole capsules will be administered orally.
Cohort 2: Lazertinib plus Rifampin
Participants will receive a single oral dose of lazertinib tablets in Treatment Period 1 followed by rifampin capsules orally along with a single oral dose of lazertinib tablet in Treatment Period 2.
Lazertinib
Lazertinib tablets will be administered orally.
Rifampin
Rifampin capsules will be administered orally.
Interventions
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Lazertinib
Lazertinib tablets will be administered orally.
Itraconazole
Itraconazole capsules will be administered orally.
Rifampin
Rifampin capsules will be administered orally.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Hormone replacement therapy (if applicable) must have been discontinued at least 28 days prior to the first dose of study drug (Cohort 2 only)
* Participants must have a body mass index (BMI) between 18.0 and 32.0 kilogram per meter square (kg/m\^2, inclusive (BMI = weight/height\^2), and body weight not less than 50 kg at screening
* Participants must be healthy based on physical examination, medical history, and vital signs (pulse and body temperature), performed at screening
* Male participants must agree to use an adequate contraception method
Exclusion Criteria
* History of infection suspected or confirmed to be related to Coronavirus disease 2019 (COVID-19) within 4 weeks before intake of study drug
* Participant has known allergies, hypersensitivity, or intolerance to lazertinib or its excipients or to itraconazole and rifampin
* Participant has contraindications to the use itraconazole and rifampin per local prescribing information
* Use of any cytochrome P450 (CYP) 3A4 inhibitors or inducers (other than per-protocol itraconazole/rifampin administration) within 4 weeks before the first dose of the study drug is scheduled until completion of the study
18 Years
60 Years
ALL
Yes
Sponsors
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Janssen Research & Development, LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Janssen Research & Development, LLC Clinical Trial
Role: STUDY_DIRECTOR
Janssen Research & Development, LLC
Locations
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Celerion
Tempe, Arizona, United States
Countries
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Other Identifiers
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73841937NSC1003
Identifier Type: OTHER
Identifier Source: secondary_id
CR108799
Identifier Type: -
Identifier Source: org_study_id
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