This study is designed to observe the effect of renal function on the pharmacokinetic, safety, and tolerability profiles of Ulipristal acetate following administration of a single oral dose of a 10 mg Ulipristal acetate tablet.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
19
Division of Clinical Pharmacology, University of Miami
Miami, Florida, United States
Clinical Pharmacology of Miami
Miami, Florida, United States
Orlando Clinical Research Center
Orlando, Florida, United States
Prism Clinical Research
Saint Paul, Minnesota, United States
Area under the plasma concentration versus time curve of ulipristal acetate from time 0 to time t (AUC 0-t)
Time frame: Day 1 (0 hour) to Day 8 (168 hours)
Maximum plasma drug concentration (Cmax) of ulipristal acetate
Time frame: Day 1 (0 hour) to Day 8 (168 hours)
Time of maximum plasma drug concentration (Tmax) of ulipristal acetate
Time frame: Day 1 (0 hour) to Day 8 (168 hours)
Terminal elimination half-life (T½) of ulipristal acetate
Time frame: Day 1 (0 hour) to Day 8 (168 hours)
Apparent total body clearance of ulipristal acetate from plasma after extravascular administration (CL/F) of ulipristal acetate
Time frame: Day 1 (0 hour) to Day 8 (168 hours)
Apparent volume of distribution during the terminal phase after extravascular administration (Vz/F) of ulipristal acetate
Time frame: Day 1 (0 hour) to Day 8 (168 hours)
Area under the plasma concentration versus time curve of ulipristal acetate from time 0 to infinity (AUC 0-∞)
Time frame: Day 1 (0 hour) to Day 8 (168 hours)
Area under the plasma concentration versus time curve of PGL4002 (ulipristal acetate active metabolite) from time 0 to time t (AUC 0-t)
Time frame: Day 1 (0 hour) to Day 8 (168 hours)
Time of maximum plasma drug concentration (Tmax) of PGL4002 (ulipristal acetate active metabolite)
Time frame: Day 1 (0 hour) to Day 8 (168 hours)
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QPS Bio-Kinetic
Springfield, Missouri, United States
Terminal elimination half-life (T½) of PGL4002 (ulipristal acetate active metabolite)
Time frame: Day 1 (0 hour) to Day 8 (168 hours)
Maximum plasma drug concentration (Cmax) of PGL4002 (ulipristal acetate active metabolite)
Time frame: Day 1 (0 hour) to Day 8 (168 hours)
Cumulative amount of ulipristal acetate excreted into urine from time zero to time t (Ae0-t)
Time frame: Day 1 (0 hour) to Day 8 (168 hours)
Renal clearance of ulipristal acetate from plasma (CLR)
Time frame: Day 1 (0 hour) to Day 8 (168 hours)
Percent of dose excreted as unchanged ulipristal acetate in urine (%Dose)
Time frame: Day 1 (0 hour) to Day 8 (168 hours)
Cumulative amount of PGL4002 excreted into urine from time zero to time t (Ae0-t)
Time frame: Day 1 (0 hour) to Day 8 (168 hours)
Renal clearance of PGL4002 from plasma (CLR)
Time frame: Day 1 (0 hour) to Day 8 (168 hours)
Area under the plasma concentration versus time curve of PGL4002 (ulipristal acetate active metabolite) from time 0 to infinity (AUC 0-∞)
Time frame: Day 1 (0 hour) to Day 8 (168 hours)