Healthy VolunteersPhase 1NCT01362764
A Study to Assess the Relative Bioavailability of Two Abiraterone Acetate Suspension Formulations Compared to the Abiraterone Acetate Tablet Formulation in Healthy Adult Volunteers
A Phase 1 study testing Abiraterone acetate suspension Formulation 1, Abiraterone acetate suspension Formulation 2 and Abiraterone acetate tablets in people with Healthy Volunteers, run by Cougar Biotechnology, Inc..
Trial summary
The purpose of this study is to compare the single-dose pharmacokinetics (how the drug is absorbed in the body, distributed within the body, and how it is removed from the body) of the solution formulation to the tablet formulation; therefore the lowest dose available in the tablet formulation (250 mg) was selected. 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?
- Abiraterone acetate suspension Formulation 1, Abiraterone acetate suspension Formulation 2 and Abiraterone acetate tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- May 2011to Jun 2011
- 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
- Having signed an informed consent document
- Agreeing to use an adequate contraception method, as deemed appropriate by the investigator (e.g., vasectomy, double-barrier, partner using effective contraception) and to not donate sperm during the study and for 3 months after receiving the last dose of study drug
- Body mass index (weight [kg]/height2 [m]2) between 18 and 30 kg/m2 (inclusive), and body weight not less than 50 kg
- Blood pressure (after the volunteer is sitting for 5 minutes) between 90 and 140 mm Hg systolic, inclusive, and no higher than 90 mm Hg diastolic during screening Days -21 to Day -1
- Having a 12-lead electrocardiogram (ECG) consistent with normal cardiac conduction and function
- Morphology consistent with healthy cardiac conduction and function
Who cannot join
- History of or current clinically significant medical illness including (but not limited to) cardiac arrhythmias or other cardiac disease, hematologic disease, coagulation disorders (including any abnormal bleeding or blood dyscrasias), lipid abnormalities, significant pulmonary disease, including bronchospastic respiratory disease, diabetes mellitus, renal or hepatic insufficiency, thyroid disease, neurologic or psychiatric disease, infection, or any other illness that the investigator considers should exclude the volunteer or that could interfere with the interpretation of the study results
- Clinically significant abnormal values for hematology, clinical chemistry or urinalysis at screening or at admission to the study center as deemed appropriate by the investigator
- Clinically significant abnormal physical examination, vital signs or 12-lead ECG at screening or at admission to the study center as deemed appropriate by the investigator
- Use of any prescription or nonprescription medication (including vitamins and herbal supplements), except for acetaminophen, within 14 days before the first dose of the study drug is scheduled
- History of, or a reason to believe a volunteer has a history of drug or alcohol abuse within the past 2 years
About this study
Official title: A Single-Dose, Open-Label, Randomized, Crossover Study to Assess the Relative Bioavailability of Two Abiraterone Acetate Suspension Formulations Compared to the Abiraterone Acetate Tablet Formulation Under Fasted Condition in Healthy Adult Subjects
The purpose of this study is to compare the single-dose pharmacokinetics (how the drug is absorbed in the body, distributed within the body, and how it is removed from the body) of the solution formulation to the tablet formulation; therefore the lowest dose available in the tablet formulation (250 mg) was selected.
Read the detailed description
This is an open-label (volunteer and study staff will know the identity of the assigned treatment) study of two abiraterone acetate suspension formulations, compared to the abiraterone acetate tablet formulation in healthy volunteers. Approximately 30 healthy volunteers will participate in this study. Each volunteer will be randomly assigned to 1 of 6 possible treatment sequences. The study consists of a screening phase (within 21 days before the first study drug administration of the first period); an open-label treatment phase consisting of 3 single dose treatment periods; and end-of-study or withdrawal assessments done upon completion of the 72-hour (Day 4 of Period 3, or upon withdrawal) sampling to evaluate how the drug is absorbed in the body, distributed within the body, and how it is removed from the body over time. A 7- to 14-day washout period will separate the study drug administrations. The duration of participation in the study for an individual healthy volunteer will be from 41 days to a maximum of 55 days (including screening). Safety will be monitored. Volunteers will receive a 250 mg dose of abiraterone acetate as a tablet, suspension Formulation 1, and suspension Formulation 2 according to their treatment sequence. Abiraterone acetate tablets must be swallowed whole and not chewed, divided, dissolved or crushed and will be taken with 240 mL of noncarbonated water. For the suspensions, the volunteer will drink the contents of the vial. The vial will be rinsed with 10 mL of water, and the volunteer will be asked to drink the rinse water.
- Conditions
- Healthy Volunteers
- Being tested
- Abiraterone acetate suspension Formulation 1, Abiraterone acetate suspension Formulation 2, Abiraterone acetate tablets
- Keywords
- Abiraterone Acetate, ZYTIGA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abiraterone acetate suspension Formulation 1Drug
Type=exact, unit=mg/mL, number=25, form=oral suspension, route=oral use, as a single dose of 10 mL
Abiraterone acetate suspension Formulation 2Drug
Type=exact, unit=mg/mL, number=25, form=oral suspension, route=oral use, as a single dose of 10 mL
Abiraterone acetate tabletsDrug
Type=exact, unit=mg, number= 250, form=tablet, route=oral use, as a single dose
| Study group | Role | What they receive |
|---|---|---|
| 001 | Other | Abiraterone acetate tablets Type=exact unit=mg number= 250 form=tablet route=oral use as a single dose Receives: Drug: Abiraterone acetate tablets |
| 002 | Other | Abiraterone acetate suspension Formulation 1 Type=exact unit=mg/mL number=25 form=oral suspension route=oral use as a single dose of 10 mL Receives: Drug: Abiraterone acetate suspension Formulation 1 |
| 003 | Other | Abiraterone acetate suspension Formulation 2 Type=exact unit=mg/mL number=25 form=oral suspension route=oral use as a single dose of 10 mL Receives: Drug: Abiraterone acetate suspension Formulation 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Levels of study drug
Measured: Up to 55 days
Secondary outcomes (5)
Vital signs evaluations
Measured: Up to 55 days
Adverse events
Measured: Up to 55 days
Clinical laboratory findings, based on blood and urine tests
Measured: Up to 55 days
Physical examination evaluations
Measured: Up to 55 days
Electrocardiogram changes
Measured: Up to 55 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2011 (estimated)
- Study startMay 2011
- Primary completionJun 2011
- Study completionJun 2011
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
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 30 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
- NCT01362764
- Sponsor's protocol ID
- CR018067
- Other IDs
- 212082HPL1001
- Status last verified
- Nov 2012
- First submitted
- 27 May 2011
- Last updated
- 27 Nov 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Dose, Open-Label, Randomized, Crossover Study to Assess the Relative Bioavailability of Two Abiraterone Acetate Suspension Formulations Compared to the Abiraterone Acetate Tablet Formulation Under Fasted Condition in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT01362764
- Acronym / sponsor ID
- CR018067
- Conditions
- Healthy Volunteers
- Keywords
- Abiraterone Acetate, ZYTIGA
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Cougar Biotechnology, Inc.Industry (pharma, biotech, devices)
- Study start
- May 2011
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 30 May 2011 (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 compare the single-dose pharmacokinetics (how the drug is absorbed in the body, distributed within the body, and how it is removed from the body) of the solution formulation to the tablet formulation; therefore the lowest dose available in the tablet formulation (250 mg) was selected.
Detailed description
This is an open-label (volunteer and study staff will know the identity of the assigned treatment) study of two abiraterone acetate suspension formulations, compared to the abiraterone acetate tablet formulation in healthy volunteers. Approximately 30 healthy volunteers will participate in this study. Each volunteer will be randomly assigned to 1 of 6 possible treatment sequences. The study consists of a screening phase (within 21 days before the first study drug administration of the first period); an open-label treatment phase consisting of 3 single dose treatment periods; and end-of-study or withdrawal assessments done upon completion of the 72-hour (Day 4 of Period 3, or upon withdrawal) sampling to evaluate how the drug is absorbed in the body, distributed within the body, and how it is removed from the body over time. A 7- to 14-day washout period will separate the study drug administrations. The duration of participation in the study for an individual healthy volunteer will be from 41 days to a maximum of 55 days (including screening). Safety will be monitored. Volunteers will receive a 250 mg dose of abiraterone acetate as a tablet, suspension Formulation 1, and suspension Formulation 2 according to their treatment sequence. Abiraterone acetate tablets must be swallowed whole and not chewed, divided, dissolved or crushed and will be taken with 240 mL of noncarbonated water. For the suspensions, the volunteer will drink the contents of the vial. The vial will be rinsed with 10 mL of water, and the volunteer will be asked to drink the rinse water.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 001 | Other | Drug: Abiraterone acetate tabletsAbiraterone acetate tablets Type=exact unit=mg number= 250 form=tablet route=oral use as a single dose |
| 002 | Other | Drug: Abiraterone acetate suspension Formulation 1Abiraterone acetate suspension Formulation 1 Type=exact unit=mg/mL number=25 form=oral suspension route=oral use as a single dose of 10 mL |
| 003 | Other | Drug: Abiraterone acetate suspension Formulation 2Abiraterone acetate suspension Formulation 2 Type=exact unit=mg/mL number=25 form=oral suspension route=oral use as a single dose of 10 mL |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Having signed an informed consent document
- Agreeing to use an adequate contraception method, as deemed appropriate by the investigator (e.g., vasectomy, double-barrier, partner using effective contraception) and to not donate sperm during the study and for 3 months after receiving the last dose of study drug
- Body mass index (weight [kg]/height2 [m]2) between 18 and 30 kg/m2 (inclusive), and body weight not less than 50 kg
- Blood pressure (after the volunteer is sitting for 5 minutes) between 90 and 140 mm Hg systolic, inclusive, and no higher than 90 mm Hg diastolic during screening Days -21 to Day -1
- Having a 12-lead electrocardiogram (ECG) consistent with normal cardiac conduction and function
Key exclusion criteria (5 listed)
- History of or current clinically significant medical illness including (but not limited to) cardiac arrhythmias or other cardiac disease, hematologic disease, coagulation disorders (including any abnormal bleeding or blood dyscrasias), lipid abnormalities, significant pulmonary disease, including bronchospastic respiratory disease, diabetes mellitus, renal or hepatic insufficiency, thyroid disease, neurologic or psychiatric disease, infection, or any other illness that the investigator considers should exclude the volunteer or that could interfere with the interpretation of the study results
- Clinically significant abnormal values for hematology, clinical chemistry or urinalysis at screening or at admission to the study center as deemed appropriate by the investigator
- Clinically significant abnormal physical examination, vital signs or 12-lead ECG at screening or at admission to the study center as deemed appropriate by the investigator
- Use of any prescription or nonprescription medication (including vitamins and herbal supplements), except for acetaminophen, within 14 days before the first dose of the study drug is scheduled
- History of, or a reason to believe a volunteer has a history of drug or alcohol abuse within the past 2 years
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 suspension Formulation 1Type=exact, unit=mg/mL, number=25, form=oral suspension, route=oral use, as a single dose of 10 mL | Drug | 002 |
| Abiraterone acetate suspension Formulation 2Type=exact, unit=mg/mL, number=25, form=oral suspension, route=oral use, as a single dose of 10 mL | Drug | 003 |
| Abiraterone acetate tabletsType=exact, unit=mg, number= 250, form=tablet, route=oral use, as a single dose | Drug | 001 |
Primary outcome
Levels of study drug
Time frame: Up to 55 days
5 secondary outcomes
Vital signs evaluations
Time frame: Up to 55 days
Adverse events
Time frame: Up to 55 days
Clinical laboratory findings, based on blood and urine tests
Time frame: Up to 55 days
Physical examination evaluations
Time frame: Up to 55 days
Electrocardiogram changes
Time frame: Up to 55 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 27 Nov 2012.
Related trials for Healthy Volunteers
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Not yet recruitingObservational study
Establishment of Biobank of Nasal Epithelium Samples From Healthy Volunteers
Healthy
RecruitingObservational study
Improved Methods of Cell Selection for Bone Marrow Transplant Alternatives
Graft-Versus-Host Disease, Graft-versus-leukemia
Not yet recruitingObservational study
Screening Protocol
Pain
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 Abiraterone acetate suspension Formulation 1, Abiraterone acetate suspension Formulation 2 and Abiraterone acetate tablets 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 6 inclusion and 5 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 27 Nov 2012. 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?
Levels of study drug (time frame: Up to 55 days). 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 27 Nov 2012.