Renal FunctionPhase 1NCT02634437
Study of Ulipristal Acetate in Female Patients With Moderately or Severely Impaired Renal Function, Compared With Matched Healthy Female Subjects
A Phase 1 study testing Ulipristal acetate in people with Renal Function, run by Allergan at 5 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Renal Function
- What is being tested?
- Ulipristal acetate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 5 sitesUnited States
- Study dates
- 1 Dec 2015to 9 Dec 2016
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Division of Clinical Pharmacology, University of Miami
Miami, Florida, 33104
Clinical Pharmacology of Miami
Miami, Florida, 33136
Orlando Clinical Research Center
Orlando, Florida, 32809
Prism Clinical Research
Saint Paul, Minnesota, 55114
QPS Bio-Kinetic
Springfield, Missouri, 65802
About this study
Official title: 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.
- Conditions
- Renal Function
- Being tested
- Ulipristal acetate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ulipristal acetateDrug
| Study group | Role | What they receive |
|---|---|---|
| Normal Renal Function | Experimental | Ulipristal acetate, 10 mg, oral administration Receives: Drug: Ulipristal acetate |
| Moderate Renal Impairment | Experimental | Ulipristal acetate, 10 mg, oral administration Receives: Drug: Ulipristal acetate |
| Severe Renal Impairment | Experimental | Ulipristal acetate, 10 mg, oral administration Receives: Drug: Ulipristal acetate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the plasma concentration versus time curve of ulipristal acetate from time 0 to time t (AUC 0-t)
Measured: Day 1 (0 hour) to Day 8 (168 hours)
Maximum plasma drug concentration (Cmax) of ulipristal acetate
Measured: Day 1 (0 hour) to Day 8 (168 hours)
Time of maximum plasma drug concentration (Tmax) of ulipristal acetate
Measured: Day 1 (0 hour) to Day 8 (168 hours)
Terminal elimination half-life (T½) of ulipristal acetate
Measured: 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
Measured: 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
Measured: 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-∞)
Measured: 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)
Measured: Day 1 (0 hour) to Day 8 (168 hours)
Time of maximum plasma drug concentration (Tmax) of PGL4002 (ulipristal acetate active metabolite)
Measured: Day 1 (0 hour) to Day 8 (168 hours)
Terminal elimination half-life (T½) of PGL4002 (ulipristal acetate active metabolite)
Measured: Day 1 (0 hour) to Day 8 (168 hours)
Maximum plasma drug concentration (Cmax) of PGL4002 (ulipristal acetate active metabolite)
Measured: 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)
Measured: Day 1 (0 hour) to Day 8 (168 hours)
Renal clearance of ulipristal acetate from plasma (CLR)
Measured: Day 1 (0 hour) to Day 8 (168 hours)
Percent of dose excreted as unchanged ulipristal acetate in urine (%Dose)
Measured: Day 1 (0 hour) to Day 8 (168 hours)
Cumulative amount of PGL4002 excreted into urine from time zero to time t (Ae0-t)
Measured: Day 1 (0 hour) to Day 8 (168 hours)
Renal clearance of PGL4002 from plasma (CLR)
Measured: 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-∞)
Measured: Day 1 (0 hour) to Day 8 (168 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2015 (estimated)
- Study start1 Dec 2015
- Primary completion9 Dec 2016
- Study completion9 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal FunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allergan
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Laishun Chen, Study director, Forest Laboratories Inc, an affiliate of Allergan plc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02634437
- Sponsor's protocol ID
- UPA-PK-02
- Status last verified
- Feb 2018
- First submitted
- 16 Dec 2015
- Last updated
- 8 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT02634437
- Acronym / sponsor ID
- UPA-PK-02
- Conditions
- Renal Function
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- AllerganIndustry (pharma, biotech, devices)
- Study start
- 1 Dec 2015 (actual)
- Primary completion
- 9 Dec 2016 (actual)
- Study completion
- 9 Dec 2016 (actual)
- First posted
- 18 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Normal Renal Function | Experimental | Drug: Ulipristal acetateUlipristal acetate, 10 mg, oral administration |
| Moderate Renal Impairment | Experimental | Drug: Ulipristal acetateUlipristal acetate, 10 mg, oral administration |
| Severe Renal Impairment | Experimental | Drug: Ulipristal acetateUlipristal acetate, 10 mg, oral administration |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ulipristal acetate | Drug | Moderate Renal Impairment, Normal Renal Function, Severe Renal Impairment |
Primary outcome
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)
Maximum plasma drug concentration (Cmax) of ulipristal acetate
Time frame: 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)
Terminal elimination half-life (T½) of ulipristal acetate
Time frame: 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)
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)
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)
10 secondary outcomes
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)
Time of maximum plasma drug concentration (Tmax) of PGL4002 (ulipristal acetate active metabolite)
Time frame: 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)
Maximum plasma drug concentration (Cmax) of PGL4002 (ulipristal acetate active metabolite)
Time frame: 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)
Renal clearance of ulipristal acetate from plasma (CLR)
Time frame: 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)
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)
Renal clearance of PGL4002 from plasma (CLR)
Time frame: 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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laishun Chen study director
Forest Laboratories Inc, an affiliate of Allergan plc
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Ulipristal acetate in people with Renal Function, run by Allergan at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2018.