Renal InsufficiencyPhase 1NCT01715259
A Pharmacokinetic Study of Abiraterone Acetate in Male Participants With Impaired Renal Function Compared to Individuals With Normal Renal Function
A Phase 1 study testing Abiraterone acetate: participants with end-stage renal disease in people with Renal Insufficiency, run by Cougar Biotechnology, Inc. at 1 site in United States.
Trial summary
The purpose of this study is to determine the pharmacokinetic (how the drug concentrations change over time) profile of abiraterone acetate 1000 mg when administered as a single dose in male participants with impaired renal function compared to individuals with normal renal function. Read more about this study
- Who is it for?
- Ages 40 to 80 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Renal Insufficiency
- What is being tested?
- Abiraterone acetate: participants with end-stage renal disease
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2009to Jan 2010
- 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 40 to 80 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All participants:
- Non-smokers or light smokers
- Body Mass Index of 18-38 kg/m2 inclusive
- Negative drug test, at screening and Day -1, for breathalyzer alcohol and drugs of abuse
- Negative HIV antibody test at screening
- Clinical laboratory values within protocol-defined parameters
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- Agrees to protocol-defined use of effective contraception
- Participants may have concurrent stable medical conditions and may be included if the deemed condition(s) will not introduce an additional risk factor and will not interfere with the study objectives and procedures
- Patients with renal impairment must additionally meet the following criteria:
- Must have protocol-defined criteria of end-stage renal disease, moderate or mild renal impairment
- Evidence of stable renal impairment
- Control participants with normal renal function must additionally meet the following criteria:
- Must be in good health
Who cannot join
- All participants:
- Medical history of malignancy except non-melanoma skin cancer
- Participation in any other investigational study drug trial in which receipt of an investigational study drug occurred within 5 half-lives of that drug or 30 days prior to dosing with abiraterone acetate, whichever is longer
- History of alcoholism or drug abuse within the past 12 months
- Significant history or clinical manifestation as determined by the Investigator of any significant metabolic, allergic, dermatological, hepatic, hematological, pulmonary, cardiovascular, immunologic, neurological, psychiatric or gastrointestinal conditions, surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs
- Clinically significant arrhythmias and/or history or presence of a clinically significantly abnormal electrocardiogram
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- Acute illness, especially any active and uncontrolled infection
- Not willing to refrain from strenuous exercise from 48-hours prior to Day -1 and during the period of confinement at the clinical site
- Not willing to abstain from consuming: grapefruit- or caffeine-containing foods or beverages for 72 hours prior to Day -1 and alcohol-containing foods or beverages for 24 hours prior to Day -1
- Donation of blood or significant loss of blood within 56 days prior to Day 1 or planned donation of blood or plasma from screening through 30 days after Day 1, inclusive
- The use of any prescription or over-the-counter (OTC) preparation known to significantly inhibit or induce liver enzymes involved in drug metabolism within 30 days prior to Day 1
- Use of any prescription medications/products or any OTC, non-prescription preparations unrelated to existing allowable stable medical conditions within 5 half-lives of that product or 7 days prior to dosing with abiraterone acetate, whichever is longer
- Any acute or chronic condition that, in the opinion of the Investigator, would limit the individual's ability to complete and/or participate in this clinical study
- Patients with renal impairment who meet any of the following criteria will be excluded from the study:
- Acute or exacerbating renal disease, fluctuating or rapidly deteriorating renal function as indicated by widely varying or worsening of signs of renal impairment within 2 weeks of Day 1
- Hypertension (systolic blood pressure [BP] >180 or diastolic BP >100)
- Control participants with normal renal function who meet any of the following criteria will be excluded from the study:
- Hypertension (systolic BP >=160 or diastolic BP >=95)
- Any significant laboratory results consistent with renal impairment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1 Single Dose Open-Label Reduced/Staged Pharmacokinetic Study of Abiraterone Acetate in Male Subjects With Impaired Renal Function Compared to Matched Control Subjects With Normal Renal Function
The purpose of this study is to determine the pharmacokinetic (how the drug concentrations change over time) profile of abiraterone acetate 1000 mg when administered as a single dose in male participants with impaired renal function compared to individuals with normal renal function.
Read the detailed description
This is an open-label (identity of assigned study drug will be known) pharmacokinetics study evaluating a single dose of abiraterone acetate 1000 mg administered in male participants with end-stage renal disease compared to matched-control (matched for age and body mass index) participants with normal renal function. There will be approximately 8 participants in each cohort (group). The total study duration for each participant will be 36 days. Abiraterone acetate 1000 mg will be administered orally (by mouth) as a single dose in the fasted state on Day 1. No food will be ingested for 4 hours post-dose. Participants will be confined to the clinical research center from the day prior to dosing (Day -1) to Day 5 and will return to the clinic on Days 8, 15, and 22 for follow up. Serial pharmacokinetic samples will be collected and safety will be monitored throughout the study.
- Conditions
- Renal Insufficiency
- Being tested
- Abiraterone acetate: participants with end-stage renal disease, Abiraterone acetate: matched control participants with normal renal function
- Keywords
- Renal insufficiency, Renal impairment, End-stage renal disease, Abiraterone acetate, Pharmacokinetics
- Medical subject headings
- Renal Insufficiency, Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abiraterone acetate: participants with end-stage renal diseaseDrug
abiraterone acetate 1000 mg (4 x 250 mg tablets) taken by mouth as a single dose in the fasted state on Day 1
Abiraterone acetate: matched control participants with normal renal functionDrug
abiraterone acetate 1000 mg (4 x 250 mg tablets) taken by mouth as a single dose in the fasted state on Day 1
| Study group | Role | What they receive |
|---|---|---|
| Abiraterone acetate | Experimental | Not described Receives: Drug: Abiraterone acetate: participants with end-stage renal disease; Drug: Abiraterone acetate: matched control participants with normal renal function |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum observed plasma concentration of abiraterone
Measured: Within 0.5 hour prior to dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, and 96 hours post-dose
Time to maximum plasma concentration of abiraterone
Measured: Within 0.5 hour prior to dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, and 96 hours post-dose
Area under the concentration-time curve from time 0 to the last measurable plasma concentration of abiraterone
Measured: Within 0.5 hour prior to dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, and 96 hours post-dose
Area under the concentration-time curve from time 0 to infinity of abiraterone
Measured: Within 0.5 hour prior to dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, and 96 hours post-dose
Terminal phase rate constant of abiraterone
Measured: Within 0.5 hour prior to dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, and 96 hours post-dose
Terminal plasma elimination half-life of abiraterone
Measured: Within 0.5 hour prior to dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, and 96 hours post-dose
Oral clearance of abiraterone
Measured: Within 0.5 hour prior to dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, and 96 hours post-dose
Apparent volume of distribution of abiraterone
Measured: Within 0.5 hour prior to dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, and 96 hours post-dose
Secondary outcomes (1)
Number of participants affected by an adverse event
Measured: Up to Day 22
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2012 (estimated)
- Study startAug 2009
- Primary completionJan 2010
- Study completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Renal InsufficiencyStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cougar Biotechnology, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Cougar Biotechnology, Inc. Clinical Trial, Study director, Cougar Biotechnology, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01715259
- Sponsor's protocol ID
- CR016951
- Other IDs
- COU-AA-012
- Status last verified
- Nov 2012
- First submitted
- 24 Oct 2012
- Last updated
- 19 Nov 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Marbury T, Lawitz E, Stonerock R, Gonzalez M, Jiao J, Breeding J, Haqq C, Verboven P, Stieltjes H, Yu M, Molina A, Acharya M, Chien C, Tran N. Single-dose pharmacokinetic studies of abiraterone acetate in men with hepatic or renal impairment. J Clin Pharmacol. 2014 Jul;54(7):732-41. doi: 10.1002/jcph.253. Epub 2014 Jan 17.
PubMed 24374856
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Single Dose Open-Label Reduced/Staged Pharmacokinetic Study of Abiraterone Acetate in Male Subjects With Impaired Renal Function Compared to Matched Control Subjects With Normal Renal Function
- ClinicalTrials.gov ID
- NCT01715259
- Acronym / sponsor ID
- CR016951
- Conditions
- Renal Insufficiency
- Keywords
- Renal insufficiency, Renal impairment, End-stage renal disease, Abiraterone acetate, Pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Cougar Biotechnology, Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2009
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 26 Oct 2012 (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.
The purpose of this study is to determine the pharmacokinetic (how the drug concentrations change over time) profile of abiraterone acetate 1000 mg when administered as a single dose in male participants with impaired renal function compared to individuals with normal renal function.
Detailed description
This is an open-label (identity of assigned study drug will be known) pharmacokinetics study evaluating a single dose of abiraterone acetate 1000 mg administered in male participants with end-stage renal disease compared to matched-control (matched for age and body mass index) participants with normal renal function. There will be approximately 8 participants in each cohort (group). The total study duration for each participant will be 36 days. Abiraterone acetate 1000 mg will be administered orally (by mouth) as a single dose in the fasted state on Day 1. No food will be ingested for 4 hours post-dose. Participants will be confined to the clinical research center from the day prior to dosing (Day -1) to Day 5 and will return to the clinic on Days 8, 15, and 22 for follow up. Serial pharmacokinetic samples will be collected and safety will be monitored throughout the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Abiraterone acetate | Experimental | Drug: Abiraterone acetate: participants with end-stage renal disease, Drug: Abiraterone acetate: matched control participants with normal renal function |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Non-smokers or light smokers
- Body Mass Index of 18-38 kg/m2 inclusive
- Negative drug test, at screening and Day -1, for breathalyzer alcohol and drugs of abuse
- Negative HIV antibody test at screening
- Clinical laboratory values within protocol-defined parameters
Key exclusion criteria (19 listed)
- Medical history of malignancy except non-melanoma skin cancer
- Participation in any other investigational study drug trial in which receipt of an investigational study drug occurred within 5 half-lives of that drug or 30 days prior to dosing with abiraterone acetate, whichever is longer
- History of alcoholism or drug abuse within the past 12 months
- Significant history or clinical manifestation as determined by the Investigator of any significant metabolic, allergic, dermatological, hepatic, hematological, pulmonary, cardiovascular, immunologic, neurological, psychiatric or gastrointestinal conditions, surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs
- Clinically significant arrhythmias and/or history or presence of a clinically significantly abnormal electrocardiogram
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 |
|---|---|---|
| Abiraterone acetate: participants with end-stage renal diseaseabiraterone acetate 1000 mg (4 x 250 mg tablets) taken by mouth as a single dose in the fasted state on Day 1 | Drug | Abiraterone acetate |
| Abiraterone acetate: matched control participants with normal renal functionabiraterone acetate 1000 mg (4 x 250 mg tablets) taken by mouth as a single dose in the fasted state on Day 1 | Drug | Abiraterone acetate |
Primary outcome
Maximum observed plasma concentration of abiraterone
Time frame: Within 0.5 hour prior to dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, and 96 hours post-dose
Time to maximum plasma concentration of abiraterone
Time frame: Within 0.5 hour prior to dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, and 96 hours post-dose
Area under the concentration-time curve from time 0 to the last measurable plasma concentration of abiraterone
Time frame: Within 0.5 hour prior to dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, and 96 hours post-dose
Area under the concentration-time curve from time 0 to infinity of abiraterone
Time frame: Within 0.5 hour prior to dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, and 96 hours post-dose
Terminal phase rate constant of abiraterone
Time frame: Within 0.5 hour prior to dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, and 96 hours post-dose
Terminal plasma elimination half-life of abiraterone
Time frame: Within 0.5 hour prior to dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, and 96 hours post-dose
Oral clearance of abiraterone
Time frame: Within 0.5 hour prior to dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, and 96 hours post-dose
Apparent volume of distribution of abiraterone
Time frame: Within 0.5 hour prior to dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, and 96 hours post-dose
1 secondary outcome
Number of participants affected by an adverse event
Time frame: Up to Day 22
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 19 Nov 2012.
- Derived from this study: PubMed 24374856Marbury T, Lawitz E, Stonerock R, Gonzalez M, Jiao J, Breeding J, Haqq C, Verboven P, Stieltjes H, Yu M, Molina A, Acharya M, Chien C, Tran N. Single-dose pharmacokinetic studies of abiraterone acetate in men with hepatic or renal impairment. J Clin Pharmacol. 2014 Jul;54(7):732-41. doi: 10.1002/jcph.253. Epub 2014 Jan 17.
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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.
Cougar Biotechnology, Inc. Clinical Trial study director
Cougar Biotechnology, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Abiraterone acetate: participants with end-stage renal disease in people with Renal Insufficiency, run by Cougar Biotechnology, Inc. at 1 site 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 13 inclusion and 19 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 19 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Maximum observed plasma concentration of abiraterone (time frame: Within 0.5 hour prior to dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, and 96 hours post-dose). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01715259, which also lists 1 linked publication.
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 19 Nov 2012.