Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Normal Renal Function | Experimental | Ulipristal acetate, 10 mg, oral administration |
|
| Moderate Renal Impairment | Experimental | Ulipristal acetate, 10 mg, oral administration |
|
| Severe Renal Impairment | Experimental | Ulipristal acetate, 10 mg, oral administration |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ulipristal acetate | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
Not provided
Inclusion Criteria for Patients with Renal Impairment:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Laishun Chen | Forest Laboratories Inc, an affiliate of Allergan plc | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Division of Clinical Pharmacology, University of Miami | Miami | Florida | 33104 | United States | ||
| Clinical Pharmacology of Miami |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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) |
| 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) |
| Renal clearance of ulipristal acetate from plasma (CLR) | 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) |
| 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) |
| Miami |
| Florida |
| 33136 |
| United States |
| Orlando Clinical Research Center | Orlando | Florida | 32809 | United States |
| Prism Clinical Research | Saint Paul | Minnesota | 55114 | United States |
| QPS Bio-Kinetic | Springfield | Missouri | 65802 | United States |
| ID | Term |
|---|---|
| C555622 | ulipristal acetate |
Not provided
Not provided
Not provided