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Completed

NCT Number: NCT03066687

A Study to Determine the Effect of Food on the Pharmacokinetics of Erdafitinib in Healthy Participants

The primary purpose of this study is to evaluate the effect of food on the relative bioavailability of a single 9 milligram (mg) oral dose of erdafitinib in healthy participants.

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Key information

Conditions

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Celerion

Lincoln, Nebraska, 68502, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Willing and able to adhere to the prohibitions and restrictions specified in this protocol
  • If a woman, must be not of childbearing potential: postmenopausal (greater than [>] 45 years of age with amenorrhea for at least 2 years, or any age with amenorrhea for at least 12 months and a serum follicle stimulating hormone [FSH] >40 International Units Per Liter [IU/L]); or surgically sterile
  • If a woman, must have a negative serum beta-human chorionic gonadotropin (hCG) pregnancy test at screening and on Day -1 of Period 1 and Period 2
  • If a woman, must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study and for 3 months after the last study drug administration
  • Body mass index (BMI; weight [kg]/height^2 [m]^2) between 18 and 32 kilogram per square meter (kg/m^2) (inclusive), and body weight not less than 50 kg
  • Non-smoker for at least 6 months before first study drug administration

Exclusion criteria

  • History of or current clinically significant medical illness including (but not limited to) cardiac arrhythmias or other cardiac disease, hematologic disease, coagulation disorders (including any abnormal bleeding or blood dyscrasias), lipid abnormalities, significant pulmonary disease, including bronchospastic respiratory disease, diabetes mellitus, hepatic or renal insufficiency, thyroid disease, neurologic or psychiatric disease, infection, or any other illness that the investigator considers should exclude the participant or that could interfere with the interpretation of the study results
  • 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
  • Clinically significant abnormal values for hematology, serum chemistry, or urinalysis at screening as deemed appropriate by the investigator
  • Clinically significant abnormal physical examination, vital signs, or 12-lead electrocardiogram (ECG) at screening as deemed appropriate by the investigator
  • Use of any prescription or nonprescription medication (including vitamins and herbal supplements), except for acetaminophen and hormonal replacement therapy, within 14 days before the first dose of the study drug is scheduled until completion of the study

Treatment and study plan

Erdafitinib

Drug

Erdafitinib 9 mg (provided as one 4-mg tablet [G-024] and one 5-mg tablet [G-025]) will be administered orally on Day 1 in each Treatment Period of assigned sequence.

Primary outcomes

  1. Maximum Observed Plasma Concentration (Cmax)

    Time frame: Predose, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 144, 192, 240, 288, and 366 hours post dose

    The Cmax is the maximum observed plasma concentration.

  2. Area Under the Plasma Concentration-Time Curve From Time Zero to Last Quantifiable Time (AUC [0-last])

    Time frame: Predose, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 144, 192, 240, 288, and 366 hours post dose

    The AUC (0-last) is the area under the plasma concentration-time curve from time zero to last quantifiable time.

  3. Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC[0-infinity])

    Time frame: Predose, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 144, 192, 240, 288, and 366 hours post dose

    The AUC (0-infinity) is the area under the plasma concentration-time curve from time zero to infinite time, calculated as the sum of AUC (last) and C(last)/lambda(z); wherein AUC(last) is area under the plasma concentration-time curve from time zero to last quantifiable time, C(last) is the last observed quantifiable concentration, and lambda(z) is elimination rate constant.

Secondary outcomes

  1. Number of Participants With Adverse Events

    Time frame: Baseline, up to end of study (Day 15 of Period 2) or early withdrawal

    Safety and Tolerability

Sponsors and collaborators

Lead sponsor

Janssen Research & Development, LLC

Industry

Collaborators

  • Celerion

Registry information

Official study title

Randomized, Open-Label, 2-Way Crossover Study to Determine the Effect of Food on the Pharmacokinetics of Erdafitinib in Healthy Subjects

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Feb 28, 2017
Registry last updated
Jun 23, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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