Prostate CancerPhase 1NCT02001571
A Study to Assess the Effect of Abiraterone Acetate in Male Participants With Mild or Moderate Hepatic Impairment Compared to Matched Control Participants With Normal Hepatic Function
A Phase 1 study testing Abiraterone acetate in people with Prostate Cancer, run by Cougar Biotechnology, Inc. at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the safety and pharmacokinetics (study of what the body does to a drug) of 1000 mg oral dose of abiraterone acetate and its major metabolite(s) with mild or moderate hepatic impairment and matched control Participants with normal hepatic function. Read more about this study
- Who is it for?
- Ages 40 to 80 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Abiraterone acetate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2009to Apr 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Non smokers or light smokers and willing to limit smoking for the period of confinement to 4 cigarettes per day
- Body Mass Index of 18-35 kg/m2
- Negative test for breathalyzer alcohol and drugs of abuse and HIV antibody test at Screening
- Agrees to protocol-defined use of effective contraception
- Participants with Mild or Moderate Hepatic Impairment
- Must have mild or moderate hepatic impairment
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- On a stable dose of medication and/or treatment regimen for at least 2 weeks before dosing as well as during the study
- Clinical laboratory evaluations within the reference range for the test laboratory
- Participants with normal hepatic function have no clinically significant findings from medical history, physical examination, Laboratory values within protocol defined parameters
Who cannot join
- Any other investigational study drug trial within 5 half-lives of that investigational study drug or 30 days prior to dosing with Abiraterone acetate, whichever is longer
- Inability to swallow four (4) 250 mg abiraterone acetate tablets
- History of or current clinically significant medical illness that would potentially alter absorption and/or excretion of orally administered drugs
- History or presence of a clinically significant abnormal ECG
- 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
- Use of any prescription medications/products or any OTC, non-prescription 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
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- Clinically significant renal laboratory findings
- Participants with Mild or Moderate Hepatic Impairment will be excluded - any significant medical history other than hepatic impairment that may affect the interpretation of the data or which otherwise contraindicates participation in the study
- Acute or exacerbating hepatitis, fluctuating or rapidly deteriorating hepatic function as indicated by widely varying or worsening of clinical and/or laboratory signs of hepatic impairment within 2 weeks
- Autoimmune liver disease; Esophageal variceal bleeding within 6 months prior to Screening, unless successfully treated with banding, Gastric varices
- Spontaneous bacterial peritonitis within 3 months prior to Screening
- Portosystemic shunt, Organ transplant, Wilson's disease, Cholestatic liver disease (e g , primary biliary cirrhosis or primary sclerosing cholangitis)
- Clinically significant laboratory findings except as related to hepatic impairment
- Control Participants with Normal Hepatic Function Any significant laboratory results, including specifically Positive for Hepatitis B or C, Hemoglobin < 12 0 g/dL LFTs outside of normal limits
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1 Single Dose Open-Label Pharmacokinetic Study of Abiraterone Acetate in Male Participants With Mild or Moderate Hepatic Impairment Compared to Matched Control Participants With Normal Hepatic Function
The purpose of this study is to evaluate the safety and pharmacokinetics (study of what the body does to a drug) of 1000 mg oral dose of abiraterone acetate and its major metabolite(s) with mild or moderate hepatic impairment and matched control Participants with normal hepatic function.
Read the detailed description
This is an open-label (identity of assigned study drug will be known) pharmacokinetics and safety study of abiraterone acetate administered as four 250 mg tablets (1000 mg) to 3 cohorts (groups) in Cohort 1 (Mild Hepatic Impairment), Cohort 2 (Moderate Hepatic Impairment) and Cohort 3 (Normal Hepatic Function). There will be approximately 8 Participants per cohort (total of approximately 24 Participants for the study). The cohorts will be dosed sequentially and activities will consist of Screening, Study and Follow-up periods, a total of up to approximately 36 days. Possible Participants will be screened to assess their eligibility to enter the study within 14 days prior to study Day 1. Participants will be confined at the Clinical Research Center (CRC) from the time of Check-in on Day -1 until discharge on Day 5. Participants will return to the CRC on Days 8 and 15 and there will be a follow-up call or visit on Day 22. A review of all clinical and laboratory data through Day 8 evaluations in each cohort will be done by the Medical Monitor and the Principal Investigator (PI) prior to proceeding with dosing any further cohort, if indicated. Safety will be monitored throughout the study.
- Conditions
- Prostate Cancer
- Being tested
- Abiraterone acetate
- Keywords
- Prostate Cancer, Abiraterone acetate, Pharmacokinetics
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abiraterone acetateDrug
On the morning of Day 1, each participant was given four 250 mg tablets of abiraterone acetate with 240 mL of room temperature tap water. Dosing followed at least a 10-hour fast from food (not including water).
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | Mild Hepatic participants administered to four 250 mg tablets (1000 mg) orally on Day 1. Receives: Drug: Abiraterone acetate |
| Cohort 2 | Experimental | Moderate Hepatic participants administered to four 250 mg tablets (1000 mg) orally on Day 1. Receives: Drug: Abiraterone acetate |
| Cohort 3 | Experimental | Normal Hepatic participants administered to four 250 mg tablets (1000 mg) orally on Day 1. Receives: Drug: Abiraterone acetate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum observed plasma concentration of abiraterone acetate
Measured: Up to 96 hours postdose
Secondary outcomes (1)
The number of Participants with adverse events
Measured: Approximately 36 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2013 (estimated)
- Study startAug 2009
- Primary completionApr 2010
- Study completionApr 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 Prostate CancerStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 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
- NCT02001571
- Sponsor's protocol ID
- CR016948
- Other IDs
- COU-AA-011
- Status last verified
- Nov 2013
- First submitted
- 31 Oct 2013
- Last updated
- 5 Dec 2013
- 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 5 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Single Dose Open-Label Pharmacokinetic Study of Abiraterone Acetate in Male Participants With Mild or Moderate Hepatic Impairment Compared to Matched Control Participants With Normal Hepatic Function
- ClinicalTrials.gov ID
- NCT02001571
- Acronym / sponsor ID
- CR016948
- Conditions
- Prostate Cancer
- Keywords
- Prostate Cancer, Abiraterone acetate, Pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Cougar Biotechnology, Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2009
- Primary completion
- Apr 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 5 Dec 2013 (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 evaluate the safety and pharmacokinetics (study of what the body does to a drug) of 1000 mg oral dose of abiraterone acetate and its major metabolite(s) with mild or moderate hepatic impairment and matched control Participants with normal hepatic function.
Detailed description
This is an open-label (identity of assigned study drug will be known) pharmacokinetics and safety study of abiraterone acetate administered as four 250 mg tablets (1000 mg) to 3 cohorts (groups) in Cohort 1 (Mild Hepatic Impairment), Cohort 2 (Moderate Hepatic Impairment) and Cohort 3 (Normal Hepatic Function). There will be approximately 8 Participants per cohort (total of approximately 24 Participants for the study). The cohorts will be dosed sequentially and activities will consist of Screening, Study and Follow-up periods, a total of up to approximately 36 days. Possible Participants will be screened to assess their eligibility to enter the study within 14 days prior to study Day 1. Participants will be confined at the Clinical Research Center (CRC) from the time of Check-in on Day -1 until discharge on Day 5. Participants will return to the CRC on Days 8 and 15 and there will be a follow-up call or visit on Day 22. A review of all clinical and laboratory data through Day 8 evaluations in each cohort will be done by the Medical Monitor and the Principal Investigator (PI) prior to proceeding with dosing any further cohort, if indicated. Safety will be monitored throughout the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: Abiraterone acetateMild Hepatic participants administered to four 250 mg tablets (1000 mg) orally on Day 1. |
| Cohort 2 | Experimental | Drug: Abiraterone acetateModerate Hepatic participants administered to four 250 mg tablets (1000 mg) orally on Day 1. |
| Cohort 3 | Experimental | Drug: Abiraterone acetateNormal Hepatic participants administered to four 250 mg tablets (1000 mg) orally on Day 1. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Non smokers or light smokers and willing to limit smoking for the period of confinement to 4 cigarettes per day
- Body Mass Index of 18-35 kg/m2
- Negative test for breathalyzer alcohol and drugs of abuse and HIV antibody test at Screening
- Agrees to protocol-defined use of effective contraception
- Participants with Mild or Moderate Hepatic Impairment
Key exclusion criteria (14 listed)
- Any other investigational study drug trial within 5 half-lives of that investigational study drug or 30 days prior to dosing with Abiraterone acetate, whichever is longer
- Inability to swallow four (4) 250 mg abiraterone acetate tablets
- History of or current clinically significant medical illness that would potentially alter absorption and/or excretion of orally administered drugs
- History or presence of a clinically significant abnormal ECG
- 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
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 acetateOn the morning of Day 1, each participant was given four 250 mg tablets of abiraterone acetate with 240 mL of room temperature tap water. Dosing followed at least a 10-hour fast from food (not including water). | Drug | Cohort 1, Cohort 2, Cohort 3 |
Primary outcome
Maximum observed plasma concentration of abiraterone acetate
Time frame: Up to 96 hours postdose
1 secondary outcome
The number of Participants with adverse events
Time frame: Approximately 36 days
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 5 Dec 2013.
- 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 in people with Prostate Cancer, 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 9 inclusion and 14 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 5 Dec 2013. 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 acetate (time frame: Up to 96 hours postdose). 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 NCT02001571, 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 5 Dec 2013.