A Single-Dose, Open-Label, Pharmacokinetic Study Of Ulipristal Acetate In Healthy Subjects With Normal Renal Function And Patients With Moderately Or Severly Impaired Renal Function
Overview
- Phase
- Phase 1
- Intervention
- Ulipristal acetate
- Conditions
- Renal Function
- Sponsor
- Allergan
- Enrollment
- 19
- Locations
- 5
- Primary Endpoint
- Maximum plasma drug concentration (Cmax) of ulipristal acetate
- Status
- Completed
- Last Updated
- 8 years ago
Overview
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.
Investigators
Eligibility Criteria
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 -
- •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
Arms & Interventions
Normal Renal Function
Ulipristal acetate, 10 mg, oral administration
Intervention: Ulipristal acetate
Moderate Renal Impairment
Ulipristal acetate, 10 mg, oral administration
Intervention: Ulipristal acetate
Severe Renal Impairment
Ulipristal acetate, 10 mg, oral administration
Intervention: Ulipristal acetate
Outcomes
Primary Outcomes
Maximum plasma drug concentration (Cmax) 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 time t (AUC 0-t)
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)
Secondary Outcomes
- 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))