The purpose of this study is to evaluate the effect of multiple doses of fluconazole (an inhibitor of cytochrome P450 \[CYP\] 2C9 and CYP3A) and itraconazole (an inhibitor of CYP3A4 and P-glycoprotein \[P-gp\]) on the pharmacokinetics of a single 4-milligram (mg) oral dose of erdafitinib in healthy adult participants.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
54
A single 4-mg of erdafitinib tablet will be administered on Day 1 in Treatment A and on Day 5 in Treatment B and C.
A 400-mg fluconazole orally (4\*100 mg capsules) will be administered from Day 1 to Day 11.
A 200-mg itraconazole orally (2\*100 mg capsules) will be administered from Day 1 to Day 11.
Clinical Pharmacology Unit
Merksem, Belgium
Maximum Observed Plasma Analyte Concentration (Cmax) of Erdafitinib
The Cmax is the maximum observed plasma analyte concentration.
Time frame: Pre-dose, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 168, 336, 504 and 672 hours post-dose
Area Under the Plasma Analyte Concentration-time Curve From the Time of 0 to one Week Post-doses [(AUC)0-168h] of Erdafitinib
Area under the plasma analyte concentration-time curve from time 0 to one week post-dose (168 hours).
Time frame: Pre-dose, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 and 168 hours post-dose
Area Under the Plasma Analyte Concentration-time Curve From Time 0 to Time of the Last Observed Quantifiable Concentration [(AUC)0-last] of Erdafitinib
\[(AUC)0-last\] is defined as area under the plasma analyte concentration-time curve from time 0 to time of the last observed quantifiable concentration (Clast).
Time frame: Pre-dose, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 168, 336, 504 and 672 hours post-dose
Area Under the Analyte Concentration-Time Curve From Time 0 to Infinite Time [(AUC)0-infinity] of Erdafitinib
\[(AUC)0-infinity\] is defined as the area under the analyte concentration-time curve from time 0 to infinite time, calculated as the sum of AUClast and Clast/lambda (z), in which Clast is the last observed quantifiable concentration and lambda (z) is the first-order rate constant associated with the terminal portion of the curve, determined as the negative slope of the terminal log-linear phase of the drug concentration-time curve.
Time frame: Pre-dose, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 168, 336, 504 and 672 hours post-dose
Percentage of Participants With Adverse Events (AEs) as a Measure of Safety
An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
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Time frame: From screening to end of study (approximately up to 61 days)