Study of Ulipristal Acetate in Female Patients With Moderately or Severely Impaired Renal Function, Compared With Matched Healthy Female Subjects
- Registration Number
- NCT02634437
- Lead Sponsor
- Allergan
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 19
Inclusion Criteria
Not provided
Exclusion Criteria
- Known hypersensitivity to Ulipristal Acetate (UPA) or other selective progesterone receptor modulators
- For Patients with Renal Impairment, clinically significant disease state, in the opinion of the examining physician, in any body system (other than renal function impairment)
- For Patients with Normal Renal Function, clinically significant disease state, in the opinion of the examining physician, in any body system
- Positive test results for anti-human immunodeficiency virus type 1, hepatitis B surface antigen, or anti-hepatitis C virus at screening
- Abnormal and clinically significant results on physical examination, medical history, serum chemistry, hematology, or urinalysis
- History of alcohol or other substance abuse within the previous 5 years
- Positive test results for benzoylecgonine (cocaine), methadone, barbiturates, amphetamines, benzodiazepines, alcohol, cannabinoids, opiates, or phencyclidine at screening or Day -1. Patients with Renal Impairment many be enrolled if the positive test result is due to prescription drug use and approved by the Principal Investigator and Sponsor Study Physician, on a case-by-case basis
- Participation in any other clinical investigation using an experimental drug requiring repeated blood or plasma draws within 30 days of IP administration
- Participation in a blood or plasma donation program within 60 or 30 days, respectively, of Investigational Product (IP) administration
- Previously participated in an investigational study of Ulipristal Acetate
- Breastfeeding
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Normal Renal Function Ulipristal acetate Ulipristal acetate, 10 mg, oral administration Moderate Renal Impairment Ulipristal acetate Ulipristal acetate, 10 mg, oral administration Severe Renal Impairment Ulipristal acetate Ulipristal acetate, 10 mg, oral administration
- Primary Outcome Measures
Name Time Method Area under the plasma concentration versus time curve of ulipristal acetate from time 0 to time t (AUC 0-t) Day 1 (0 hour) to Day 8 (168 hours) Maximum plasma drug concentration (Cmax) of ulipristal acetate Day 1 (0 hour) to Day 8 (168 hours) Time of maximum plasma drug concentration (Tmax) of ulipristal acetate Day 1 (0 hour) to Day 8 (168 hours) Terminal elimination half-life (T½) of ulipristal acetate 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 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 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-∞) Day 1 (0 hour) to Day 8 (168 hours)
- Secondary Outcome Measures
Name Time Method Cumulative amount of ulipristal acetate excreted into urine from time zero to time t (Ae0-t) 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) Day 1 (0 hour) to Day 8 (168 hours) Time of maximum plasma drug concentration (Tmax) of PGL4002 (ulipristal acetate active metabolite) Day 1 (0 hour) to Day 8 (168 hours) Terminal elimination half-life (T½) of PGL4002 (ulipristal acetate active metabolite) Day 1 (0 hour) to Day 8 (168 hours) Maximum plasma drug concentration (Cmax) of PGL4002 (ulipristal acetate active metabolite) Day 1 (0 hour) to Day 8 (168 hours) Renal clearance of ulipristal acetate from plasma (CLR) Day 1 (0 hour) to Day 8 (168 hours) Renal clearance of PGL4002 from plasma (CLR) 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-∞) Day 1 (0 hour) to Day 8 (168 hours) Percent of dose excreted as unchanged ulipristal acetate in urine (%Dose) Day 1 (0 hour) to Day 8 (168 hours) Cumulative amount of PGL4002 excreted into urine from time zero to time t (Ae0-t) Day 1 (0 hour) to Day 8 (168 hours)
Trial Locations
- Locations (5)
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
QPS Bio-Kinetic
🇺🇸Springfield, Missouri, United States