A multiple dose relative bioavailability study in patients with prostate cancer comparing a capsule and a tablet formulation of enzalutamide.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
27
Oral
Oral
University of Colorado - Anschutz Medical Campus
Denver, Colorado, United States
University of Chicago Medical Center
Chicago, Illinois, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
South Texas Accelerated Research Therapeutics
San Antonio, Texas, United States
Pharmacokinetic profile of Enzalutamide under fasted conditions measured by Cmax (Maximum concentration)
Day 56 (fasted) Cmax under steady state conditions of enzalutamide
Time frame: Day1 through Day 56 (12 samples)
Pharmacokinetic profile of Enzalutamide under fasted conditions measured by AUC0-24h (Area under the concentration-time curve 0-24h)
Day 56 (fasted) AUC0-24h under steady state conditions of enzalutamide
Time frame: Day1 through Day 56 (12 samples)
Pharmacokinetic profile of Enzalutamide under fasted and fed conditions
Measured by: Cmax, tmax (Time to attain Cmax), AUC0-24h, Ctrough (Trough concentration), PTR (Peak-trough ratio), CLss/F (Apparent clearance at steady state)
Time frame: Day 1, 8, 29, 55, 56 and 57 (38 samples)
Pharmacokinetic profile of MDPC0001 alone, MDPC0002 alone and sum of Enzalutamide plus MDPC0002
Measured by: Ctrough, Cmax, tmax, AUC0-24h, Ctrough (24h after dosing), PTR
Time frame: Day 8, 29, 55, 56 and 57 (26 samples)
Evaluation of the safety and tolerability of two oral formulations of Enzalutamide assessed through vital signs, adverse events, electrocardiogram and clinical laboratory assessments
Time frame: Day 1 through Day 58
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