Clinical trial NCT03066687: A Study to Determine the Effect of Food on the Pharmacokinetics of Erdafitinib in Healthy Participants
Official title: Randomized, Open-Label, 2-Way Crossover Study to Determine the Effect of Food on the Pharmacokinetics of Erdafitinib in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
Collaborators: name: Celerion
First posted: 2017-02-28
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Maximum Observed Plasma Concentration (Cmax)
timeFrame: Predose, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 144, 192, 240, 288, and 366 hours post dose
measure: Area Under the Plasma Concentration-Time Curve From Time Zero to Last Quantifiable Time (AUC [0-last])
timeFrame: Predose, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 144, 192, 240, 288, and 366 hours post dose
measure: Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC[0-infinity])
timeFrame: Predose, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 144, 192, 240, 288, and 366 hours post dose
Secondary outcomes:
measure: Number of Participants With Adverse Events
timeFrame: Baseline, up to end of study (Day 15 of Period 2) or early withdrawal
Other outcomes:
Locations:
city: Lincoln
country: United States
facility: Celerion
state: Nebraska
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References: