A Study of Steady-state Carbamazepine on the Single-dose of Erdafitinib Tablets in Healthy Adult Participants

  • STATUS
    Recruiting
  • End date
    Feb 1, 2023
  • participants needed
    17
  • sponsor
    Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Updated on 6 June 2022
Accepts healthy volunteers

Summary

The main purpose of this study is to evaluate the effect of multiple doses of carbamazepine (a strong inducer of cytochrome P450 [CYP]3A4 and a weak inducer of CYP2C9) on the pharmacokinetics of a single oral dose of erdafitinib in healthy adult participants.

Details
Condition Healthy
Treatment Carbamazepine, rifampin, Erdafitinib
Clinical Study IdentifierNCT04330248
SponsorJohnson & Johnson Pharmaceutical Research & Development, L.L.C.
Last Modified on6 June 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Healthy on the basis of physical examination, medical history, and vital signs (blood pressure, pulse, and body temperature) performed at screening
Healthy on the basis of clinical laboratory tests performed at screening. If the results of the serum chemistry panel and hematology panel are outside the normal reference ranges, the participant may be included only if the investigator judges the abnormalities or deviations from normal to be not clinically significant. This determination must be recorded in the participant's source documents and initialed by the investigator. Participants must have sodium and phosphate levels within normal limits; hematological parameters (Hemoglobin, red blood cell [RBC] count, white blood cell [WBC] count, absolute neutrophil count, platelet count) within normal limits; and total bilirubin, alanine aminotransferase (ALT), aspartate amino transferase (AST), and alkaline phosphatase (ALP) serum levels lower than or equal to the upper limit of normal at screening
Willing and able to adhere to the prohibitions and restrictions specified in this protocol
Must agree to have a pharmacogenomic blood sample (5 milliliters [mL]) collected at screening to allow for pharmacogenomic analysis
Non-smoker for at least 6 months before first study drug administration

Exclusion Criteria

History or current evidence of ophthalmic disorder, such as central serous retinopathy (CSR) or retinal vein occlusion, active wet age-related macular degeneration, diabetic retinopathy with macular edema, uncontrolled glaucoma, corneal pathology such as keratitis, keratoconjunctivitis, keratopathy, corneal abrasion, inflammation, or ulceration
History of depression or suicidal ideation
Use of any prescription or nonprescription medication (including vitamins and herbal supplements), except for paracetamol (a maximum of 3 doses per day of 500 milligram [mg] paracetamol, and no more than 3 gram [g] per week), hormonal replacement therapy and cetirizine (in case of allergic reactions), within 14 days before the first dose of the study drug is scheduled until completion of the study
Received an experimental drug or used an experimental medical device within 1 month or within a period less than 5 times the drug's half-life, whichever is longer, before the first dose of the study drug is scheduled
Known allergies, hypersensitivity, or intolerance to erdafitinib or carbamazepine or any of the excipients of the formulations
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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