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

NCT02634437 | Completed Phase 1

• 1 other identifier: UPA-PK-02
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 5

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

Outcome Measures

Primary Outcomes (7)

• 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 Outcomes (10)

• 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)

• 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)

Study Arms (3)

Normal Renal Function

EXPERIMENTAL

Ulipristal acetate, 10 mg, oral administration

Drug: Ulipristal acetate

Moderate Renal Impairment

EXPERIMENTAL

Ulipristal acetate, 10 mg, oral administration

Drug: Ulipristal acetate

Severe Renal Impairment

EXPERIMENTAL

Ulipristal acetate, 10 mg, oral administration

Drug: Ulipristal acetate

Interventions

Ulipristal acetate DRUG

Moderate Renal Impairment; Normal Renal Function; Severe Renal Impairment

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

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

Sponsors & Collaborators

• Allergan: lead

Study Sites (5)

Division of Clinical Pharmacology, University of Miami

Miami, Florida, 33104, United States

Location

Clinical Pharmacology of Miami

Miami, Florida, 33136, United States

Location

Orlando Clinical Research Center

Orlando, Florida, 32809, United States

Location

Prism Clinical Research

Saint Paul, Minnesota, 55114, United States

Location

QPS Bio-Kinetic

Springfield, Missouri, 65802, United States

Location

MeSH Terms

Interventions

ulipristal acetate

Study Officials

• Laishun Chen

  Forest Laboratories Inc, an affiliate of Allergan plc

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2015
• First Posted: December 18, 2015
• Study Start: December 1, 2015
• Primary Completion: December 9, 2016
• Study Completion: December 9, 2016
• Last Updated: February 8, 2018

Record last verified: 2018-02

Locations

US (5)