A study to evaluate the bioavailability (BA) of a single oral dose of MDV3100 (enzalutamide) formulated as a solid spray dried tablet compared to oral liquid-filled capsules, and the safety and tolerability of oral formulations. Subjects are admitted to the clinic from days 1 to 5, followed by outpatient assessments up to Day 50. They return to the clinic for an end of study visit (ESV) 7-10 days after the last pharmacokinetic (PK) sampling or after early withdrawal.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
55
Oral
Parexel International GmbH
Berlin, Germany
Relative BA of capsule and tablet formulations of enzalutamide following a single dose of enzalutamide under fasted conditions
AUC0-t (Area Under Curve from time zero to last quantifiable sample), AUC0-inf (AUC extrapolated to infinity), Cmax (Maximum concentration)
Time frame: Day 1 through Day 50 (26 times)
Relative BA of capsule and tablet formulations of enzalutamide following a single dose of enzalutamide under fasted conditions
AUC0-72h (AUC from time zero to 72h post dose), AUC0-t, AUC0-inf, %AUC (Percentage of AUC), Cmax, tmax (Time to attain Cmax), λz (Terminal elimination rate constant), t1/2 (Terminal elimination half life), (MPR) metabolites to parent ratio, MPR(molecular weight corrected \[MWC\]), %AUC, CL/F (apparent oral clearance), Vz/F (apparent volume of distribution)
Time frame: Day 1 through Day 50 (26 times)
Safety and tolerability of oral formulations of enzalutamide
adverse events, physical examination, vital signs, clinical laboratory tests, 12-lead Electrocardiogram (ECG)
Time frame: Screening through ESV (7-10 days after the last pharmacokinetic (PK) sampling or after early withdrawal)
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