Study of Ulipristal Acetate in Female Patients With Moderately or Severely Impaired Renal Function, Compared With Matched Healthy Female Subjects

Completed · Phase 1

Conditions studied: Renal Function

In brief

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.

Key facts

Study ID

NCT02634437

Run by

Allergan

People needed

19

Starts

2015-12-01

Expected to finish

2016-12-09

Last updated by the study team

2018-02-08

Who can join

Age: 18 and older, up to 80. Sex: female. Healthy volunteers: accepted.

You may not qualify if…

• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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