Celerion
Lincoln, Nebraska, 68502, United States
NCT Number: NCT03066687
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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Notify Me18 year–55 year
All sexes
Interventional
Phase 1
Lincoln, Nebraska, 68502, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
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.
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.
Time frame: Baseline, up to end of study (Day 15 of Period 2) or early withdrawal
Safety and Tolerability
Janssen Research & Development, LLC
Industry
Randomized, Open-Label, 2-Way Crossover Study to Determine the Effect of Food on the Pharmacokinetics of Erdafitinib in Healthy Subjects
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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