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

NCT ID: NCT02634437

Last Updated: 2018-02-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-12-01
• Study Completion Date: 2016-12-09

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.

Conditions

Renal Function

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Normal Renal Function

Ulipristal acetate, 10 mg, oral administration

Group Type: EXPERIMENTAL

Ulipristal acetate

Intervention Type: DRUG

Moderate Renal Impairment

Ulipristal acetate, 10 mg, oral administration

Group Type: EXPERIMENTAL

Ulipristal acetate

Intervention Type: DRUG

Severe Renal Impairment

Ulipristal acetate, 10 mg, oral administration

Group Type: EXPERIMENTAL

Ulipristal acetate

Intervention Type: DRUG

Interventions

Ulipristal acetate

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Have a negative result from a serum pregnancy test at screening and a negative result from a serum or urine pregnancy test on Day -1
• If premenopausal, have regular menstrual cycles (cycles of 24-35 days duration) over the past 6 months as reported by the patient
• If female of childbearing potential, agree to use an effective method of contraception (i.e., condom plus diaphragm with spermicide, condom with spermicide, or nonhormonal intrauterine device) and not become pregnant throughout the study. Subjects who are at least 2-years postmenopausal (with supporting documentation from an obstetrician/gynecologist) or who have had tubal ligation or hysterectomy will not be considered to be of childbearing potential
• Be nonsmoking (never smoked or have not smoked within the previous 6 months) or a light smoker (fewer than 10 cigarettes per day within the previous 3 months)
• For Patients with Renal Impairment, have medical history, physical examination, laboratory, and other test results consistent with their degree of renal impairment, as determined by the Investigator
• For Patients with Normal Renal Function, have a state of general good health based on medical history and routine physical examination and are matched to the age and weight of the renal dysfunction patients (mean group difference ±10 years for age and < 20% for weight)

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Allergan

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Laishun Chen

Role: STUDY_DIRECTOR

Forest Laboratories Inc, an affiliate of Allergan plc

Locations

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

Countries

United States

Other Identifiers

UPA-PK-02

Identifier Type: -

Identifier Source: org_study_id