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

February 6, 2018 updated by: Allergan

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
19

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Miami, Florida, United States, 33104
        • Division of Clinical Pharmacology, University of Miami
      • Miami, Florida, United States, 33136
        • Clinical Pharmacology of Miami
      • Orlando, Florida, United States, 32809
        • Orlando Clinical Research Center
    • Minnesota
      • Saint Paul, Minnesota, United States, 55114
        • Prism Clinical Research
    • Missouri
      • Springfield, Missouri, United States, 65802
        • QPS Bio-Kinetic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria for Patients with Renal Impairment:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Normal Renal Function
Ulipristal acetate, 10 mg, oral administration
Drug: Ulipristal acetate
Experimental: Moderate Renal Impairment
Ulipristal acetate, 10 mg, oral administration
Drug: Ulipristal acetate
Experimental: Severe Renal Impairment
Ulipristal acetate, 10 mg, oral administration
Drug: Ulipristal acetate

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
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)
Day 1 (0 hour) to Day 8 (168 hours)
Maximum plasma drug concentration (Cmax) of ulipristal acetate
Time Frame: Day 1 (0 hour) to Day 8 (168 hours)
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)
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)
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)
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)
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)
Day 1 (0 hour) to Day 8 (168 hours)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
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)
Time Frame: Day 1 (0 hour) to Day 8 (168 hours)
Day 1 (0 hour) to Day 8 (168 hours)
Time of maximum plasma drug concentration (Tmax) of PGL4002 (ulipristal acetate active metabolite)
Time Frame: Day 1 (0 hour) to Day 8 (168 hours)
Day 1 (0 hour) to Day 8 (168 hours)
Terminal elimination half-life (T½) of PGL4002 (ulipristal acetate active metabolite)
Time Frame: Day 1 (0 hour) to Day 8 (168 hours)
Day 1 (0 hour) to Day 8 (168 hours)
Maximum plasma drug concentration (Cmax) of PGL4002 (ulipristal acetate active metabolite)
Time Frame: Day 1 (0 hour) to Day 8 (168 hours)
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)
Time Frame: Day 1 (0 hour) to Day 8 (168 hours)
Day 1 (0 hour) to Day 8 (168 hours)
Renal clearance of ulipristal acetate from plasma (CLR)
Time Frame: Day 1 (0 hour) to Day 8 (168 hours)
Day 1 (0 hour) to Day 8 (168 hours)
Percent of dose excreted as unchanged ulipristal acetate in urine (%Dose)
Time Frame: Day 1 (0 hour) to Day 8 (168 hours)
Day 1 (0 hour) to Day 8 (168 hours)
Cumulative amount of PGL4002 excreted into urine from time zero to time t (Ae0-t)
Time Frame: Day 1 (0 hour) to Day 8 (168 hours)
Day 1 (0 hour) to Day 8 (168 hours)
Renal clearance of PGL4002 from plasma (CLR)
Time Frame: Day 1 (0 hour) to Day 8 (168 hours)
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-∞)
Time Frame: Day 1 (0 hour) to Day 8 (168 hours)
Day 1 (0 hour) to Day 8 (168 hours)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Allergan

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Laishun Chen, Forest Laboratories Inc, an affiliate of Allergan plc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 9, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 9, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 16, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 17, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 18, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 8, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 6, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • UPA-PK-02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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