A Study to Determine the Effect of Food on the Pharmacokinetics of Erdafitinib in Healthy Participants
Status: | Completed |
---|---|
Conditions: | Healthy Studies |
Therapuetic Areas: | Other |
Healthy: | No |
Age Range: | 18 - 55 |
Updated: | 6/24/2017 |
Start Date: | March 14, 2017 |
End Date: | May 12, 2017 |
Randomized, Open-Label, 2-Way Crossover Study to Determine the Effect of Food on the Pharmacokinetics of Erdafitinib in Healthy Subjects
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.
bioavailability of a single 9 milligram (mg) oral dose of erdafitinib in healthy
participants.
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
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