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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
15
Participants will receive single oral dose of erdafitinib tablets on Day 1 in Period 1 and on Day 28 in Period 2.
Participants will receive an oral dose of carbamazepine tablets from Day 15 to 35 in Period 2.
Clinical Pharmacology Unit
Merksem, Belgium
Maximum Observed Plasma (Cmax) of Erdafitinib
Cmax is defined as the maximum observed plasma of erdafitinib concentration.
Time frame: Predose (Day 28) 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 168 and 312 hours postdose (Day 41)
Area Under the Plasma Analyte Concentration-Time Curve 0 from Time 0 to one week Postdose (AUC[0-168 hours])
AUC (0-168 hours) is defined as the area under the plasma analyte concentration-time curve from time 0 to one week postdose (168 hours).
Time frame: Predose (Day 28) 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, and 168 hours postdose (Day 35)
Area Under the Plasma Analyte Concentration-Time Curve from Time 0 to Time of the Last Observed Quantifiable Concentration (AUC [0-last])
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.
Time frame: Predose (Day 28) 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 168 and 312 hours postdose (Day 41)
Area Under the Analyte Concentration-Time Curve from Time 0 to Infinite Time (AUC [0-infinity])
AUC (0-infinity) is defined as the area under the analyte concentration-time curve from time 0 to infinite time.
Time frame: Predose (Day 28) 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 168 and 312 hours postdose (Day 41)
Number of Participants with Adverse Events (AE) as a Measure of Safety and Tolerability
An AE 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.
Time frame: Up to Day 79 (end of study)
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