Healthy VolunteersPhase 1NCT01798628
A Study to Determine the Effect of Food on the Pharmacokinetics of Abiraterone Acetate in Healthy Male Patients
A Phase 1 study testing Treatment A: abiraterone acetate, Treatment B: abiraterone acetate and Treatment C: abiraterone acetate in people with Healthy Volunteers, run by Cougar Biotechnology, Inc..
Trial summary
The purpose of this study is to determine the effect of food on the pharmacokinetics (how the drug concentrations change over time) of abiraterone acetate 1000 mg when administered as a single dose in healthy male volunteers. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Treatment A: abiraterone acetate, Treatment B: abiraterone acetate and Treatment C: abiraterone acetate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- No sites listed yet
- Study dates
- Sep 2009to Oct 2009
- 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 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- In good general health as determined by no clinically significant findings on medical history, physical examination, vital signs, 12-lead electrocardiogram, and clinical laboratory measurements
- Body mass index within 18 kg/m2 to 32 kg/m2, inclusive
- Non-tobacco users
- Clinical laboratory values within protocol-defined parameters
- Negative hepatitis panel (including hepatitis B surface antigen [HBsAg] and hepatitis C virus antibody [anti-HCV]),and negative human immunodeficiency virus (HIV) antibody screens
- Negative test for selected drugs of abuse
- Agrees to protocol-defined use of effective contraception
Who cannot join
- Significant history or manifestation of any significant metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological or psychiatric disorder, as determined by the Principal Investigator
- History or presence of an abnormal electrocardiogram
- History of stomach or intestinal surgery resection that would potentially alter absorption and/or excretion of orally administered drugs
- Screening serum total testosterone of <200 ng/dL
- History of hypersensitivity reaction to the study drug, related compounds or excipients used in the formulation
- Receipt of an investigational drug within 5 half-lives or 30 days prior to Day -1, whichever is longer
Show all 22Show fewer
- Abnormal diet during the 30 days prior to Day 1
- Donation of blood or significant loss of blood within 56 days or plasma within 14 days prior to Day -1
- Planned donation of blood or plasma from Screening through Study Completion, Day 21
- Receipt of blood products within 2 months prior to Day 1
- History of protocol-defined alcohol abuse
- Known or suspected use of illicit drugs within the last year
- Use of any medication on a chronic basis
- Use of any prescription medications/products or over-the-counter non-prescription preparations within 5 half-lives or 7 days prior to Day -1 unless deemed acceptable by the Sponsor
- Consumption of alcohol-containing foods or beverages within 24 hours prior to the first Check-in (Day -1)
- Unwillingness to abstain from alcohol consumption from Day -1 to Study Completion (Day21)
- Consumption of caffeine-containing or grapefruit-containing foods or beverages within 72 hours prior to Day -1
- Unwillingness to abstain from caffeine-containing or grapefruit-containing foods or beverages from Day -1 through Study Completion (Day21)
- Presence of sexual dysfunction or any medical condition that would affect sexual function
- Unwillingness to refrain from strenuous exercise from 48 hours prior to Day -1 and for the duration of the study
- Presence of any condition that, in the opinion of the Investigator, would limit the participant's ability to complete and/or participate in this study
- Unwillingness to refrain from using any tobacco or nicotine-containing products during screening and throughout the study to Study Completion (Day 21)
About this study
Official title: A Phase 1, Single Dose, Open-Label, Three-Period, Crossover Study to Determine the Effect of Food on the Pharmacokinetics of Abiraterone Acetate in Healthy Male Subjects
The purpose of this study is to determine the effect of food on the pharmacokinetics (how the drug concentrations change over time) of abiraterone acetate 1000 mg when administered as a single dose in healthy male volunteers.
Read the detailed description
This is an open-label (identity of assigned study drug will be known), randomized (treatment sequences will be assigned by chance) study of a single dose of abiraterone acetate 1000 mg administered orally (by mouth) in approximately 36 healthy male participants under fasted and fed conditions. Three doses of abiraterone acetate will be administered with a 7-day washout period between each dose. The total study duration for each participant will be 21 days. Participants will be randomized to one of six treatment sequences (ABC, ACB, BAC, BCA, CAB, CBA): Treatment A = abiraterone acetate 1000 mg administered after a high-fat meal; Treatment B = abiraterone acetate 1000 mg administered after a low-fat meal; Treatment C = abiraterone acetate 1000 mg administered in the fasted state. No food will be ingested for 4 hours post-dose. Participants will be confined at the clinical research unit from the day prior to dosing until clinic discharge on the day following dosing in each treatment period. Serial pharmacokinetic samples will be collected and safety will be monitored throughout the study.
- Conditions
- Healthy Volunteers
- Being tested
- Treatment A: abiraterone acetate, Treatment B: abiraterone acetate, Treatment C: abiraterone acetate
- Keywords
- Healthy volunteers, Abiraterone acetate, Pharmacokinetics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment A: abiraterone acetateDrug
1000 mg (4 x 250 mg tablets) taken by mouth as a single dose administered after a high-fat meal
Treatment B: abiraterone acetateDrug
1000 mg (4 x 250 mg tablets) taken by mouth as a single dose after a low-fat meal
Treatment C: abiraterone acetateDrug
1000 mg (4 x 250 mg tablets) taken by mouth as a single dose administered in the fasted state
| Study group | Role | What they receive |
|---|---|---|
| Sequence ABC | Experimental | Not described Receives: Drug: Treatment A: abiraterone acetate; Drug: Treatment B: abiraterone acetate; Drug: Treatment C: abiraterone acetate |
| Sequence ACB | Experimental | Not described Receives: Drug: Treatment A: abiraterone acetate; Drug: Treatment B: abiraterone acetate; Drug: Treatment C: abiraterone acetate |
| Sequence BAC | Experimental | Not described Receives: Drug: Treatment A: abiraterone acetate; Drug: Treatment B: abiraterone acetate; Drug: Treatment C: abiraterone acetate |
| Sequence BCA | Experimental | Not described Receives: Drug: Treatment A: abiraterone acetate; Drug: Treatment B: abiraterone acetate; Drug: Treatment C: abiraterone acetate |
| Sequence CAB | Experimental | Not described Receives: Drug: Treatment A: abiraterone acetate; Drug: Treatment B: abiraterone acetate; Drug: Treatment C: abiraterone acetate |
| Sequence CBA | Experimental | Not described Receives: Drug: Treatment A: abiraterone acetate; Drug: Treatment B: abiraterone acetate; Drug: Treatment C: abiraterone acetate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum observed concentration of abiraterone
Measured: Within 1 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 concentration of abiraterone
Measured: Within 1 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 concentration of abiraterone
Measured: Within 1 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 extrapolated to infinity of abiraterone
Measured: Within 1 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 plasma terminal elimination rate constant of abiraterone
Measured: Within 1 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 terminal elimination half-life of abiraterone
Measured: Within 1 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 21
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2013 (estimated)
- Study startSep 2009
- Primary completionOct 2009
- Study completionOct 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 36 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
- NCT01798628
- Sponsor's protocol ID
- CR016960
- Other IDs
- COU-AA-009
- Status last verified
- Feb 2013
- First submitted
- 22 Oct 2012
- Last updated
- 26 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Single Dose, Open-Label, Three-Period, Crossover Study to Determine the Effect of Food on the Pharmacokinetics of Abiraterone Acetate in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT01798628
- Acronym / sponsor ID
- CR016960
- Conditions
- Healthy Volunteers
- Keywords
- Healthy volunteers, Abiraterone acetate, Pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Cougar Biotechnology, Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2009
- Primary completion
- Oct 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 26 Feb 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 determine the effect of food on the pharmacokinetics (how the drug concentrations change over time) of abiraterone acetate 1000 mg when administered as a single dose in healthy male volunteers.
Detailed description
This is an open-label (identity of assigned study drug will be known), randomized (treatment sequences will be assigned by chance) study of a single dose of abiraterone acetate 1000 mg administered orally (by mouth) in approximately 36 healthy male participants under fasted and fed conditions. Three doses of abiraterone acetate will be administered with a 7-day washout period between each dose. The total study duration for each participant will be 21 days. Participants will be randomized to one of six treatment sequences (ABC, ACB, BAC, BCA, CAB, CBA): Treatment A = abiraterone acetate 1000 mg administered after a high-fat meal; Treatment B = abiraterone acetate 1000 mg administered after a low-fat meal; Treatment C = abiraterone acetate 1000 mg administered in the fasted state. No food will be ingested for 4 hours post-dose. Participants will be confined at the clinical research unit from the day prior to dosing until clinic discharge on the day following dosing in each treatment period. Serial pharmacokinetic samples will be collected and safety will be monitored throughout the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Sequence ABC | Experimental | Drug: Treatment A: abiraterone acetate, Drug: Treatment B: abiraterone acetate, Drug: Treatment C: abiraterone acetate |
| Sequence ACB | Experimental | Drug: Treatment A: abiraterone acetate, Drug: Treatment B: abiraterone acetate, Drug: Treatment C: abiraterone acetate |
| Sequence BAC | Experimental | Drug: Treatment A: abiraterone acetate, Drug: Treatment B: abiraterone acetate, Drug: Treatment C: abiraterone acetate |
| Sequence BCA | Experimental | Drug: Treatment A: abiraterone acetate, Drug: Treatment B: abiraterone acetate, Drug: Treatment C: abiraterone acetate |
| Sequence CAB | Experimental | Drug: Treatment A: abiraterone acetate, Drug: Treatment B: abiraterone acetate, Drug: Treatment C: abiraterone acetate |
| Sequence CBA | Experimental | Drug: Treatment A: abiraterone acetate, Drug: Treatment B: abiraterone acetate, Drug: Treatment C: abiraterone acetate |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- In good general health as determined by no clinically significant findings on medical history, physical examination, vital signs, 12-lead electrocardiogram, and clinical laboratory measurements
- Body mass index within 18 kg/m2 to 32 kg/m2, inclusive
- Non-tobacco users
- Clinical laboratory values within protocol-defined parameters
- Negative hepatitis panel (including hepatitis B surface antigen [HBsAg] and hepatitis C virus antibody [anti-HCV]),and negative human immunodeficiency virus (HIV) antibody screens
Key exclusion criteria (22 listed)
- Significant history or manifestation of any significant metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological or psychiatric disorder, as determined by the Principal Investigator
- History or presence of an abnormal electrocardiogram
- History of stomach or intestinal surgery resection that would potentially alter absorption and/or excretion of orally administered drugs
- Screening serum total testosterone of <200 ng/dL
- History of hypersensitivity reaction to the study drug, related compounds or excipients used in the formulation
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 |
|---|---|---|
| Treatment A: abiraterone acetate1000 mg (4 x 250 mg tablets) taken by mouth as a single dose administered after a high-fat meal | Drug | Sequence ABC, Sequence ACB, Sequence BAC, Sequence BCA, Sequence CAB, Sequence CBA |
| Treatment B: abiraterone acetate1000 mg (4 x 250 mg tablets) taken by mouth as a single dose after a low-fat meal | Drug | Sequence ABC, Sequence ACB, Sequence BAC, Sequence BCA, Sequence CAB, Sequence CBA |
| Treatment C: abiraterone acetate1000 mg (4 x 250 mg tablets) taken by mouth as a single dose administered in the fasted state | Drug | Sequence ABC, Sequence ACB, Sequence BAC, Sequence BCA, Sequence CAB, Sequence CBA |
Primary outcome
Maximum observed concentration of abiraterone
Time frame: Within 1 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 concentration of abiraterone
Time frame: Within 1 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 concentration of abiraterone
Time frame: Within 1 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 extrapolated to infinity of abiraterone
Time frame: Within 1 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 plasma terminal elimination rate constant of abiraterone
Time frame: Within 1 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 terminal elimination half-life of abiraterone
Time frame: Within 1 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 21
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 26 Feb 2013.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Treatment A: abiraterone acetate, Treatment B: abiraterone acetate and Treatment C: abiraterone acetate in people with Healthy Volunteers, run by Cougar Biotechnology, Inc..
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 7 inclusion and 22 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 26 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
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 concentration of abiraterone (time frame: Within 1 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 6 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 26 Feb 2013.