Healthy ParticipantsPhase 1NCT01640093
A Comparative Study of Bioavailability of 3 New Abiraterone Acetate Tablets With Current Commercial Tablet
A Phase 1 study testing Abiraterone acetate, 250 mg (uncoated, current commercial tablet), Abiraterone acetate, 500 mg (coated, reformulated tablet) and Abiraterone acetate, 250 mg (coated, reformulated tablet) in people with Healthy Participants, run by Janssen Research & Development, LLC at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the pharmacokinetics (what the body does to the medication) and relative bioavailability of 3 newly developed abiraterone acetate tablet formulations compared with the current commercial abiraterone acetate tablet formulation in healthy male participants, under fasted… 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 Participants
- What is being tested?
- Abiraterone acetate, 250 mg (uncoated, current commercial tablet), Abiraterone acetate, 500 mg (coated, reformulated tablet) and Abiraterone acetate, 250 mg (coated, reformulated tablet)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- May 2012to Jul 2012
- 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
- Have body weight not less than 50 kg
- Must be a non-smoker, and has no history of smoking or use of nicotine-containing substances within the previous 2 months
- Must have blood pressure between 90 and 140 mmHg systolic, inclusive, and no higher than 90 mmHg diastolic
- Must have a 12-lead electrocardiogram consistent with normal cardiac conduction and function
- Must agree to use an adequate contraception method as deemed appropriate by the investigator and to not donate sperm during the study for 3 months after receiving the last dose of study medication
Who cannot join
- History of or current clinically significant medical illness including cardiac arrhythmias or other cardiac disease that could interfere with the interpretation of the study results
- Clinically significant abnormal values for hematology or urinalysis (at screening)
- Clinically significant abnormal physical examination vital signs or 12-lead electrocardiogram (at screening)
- Usage of any prescription or nonprescription medication, except for acetaminophen, and oral contraceptives and hormonal replacement therapy within 14 days before the first dose of the study medication is scheduled
- Unable to swallow solid, oral dosage forms whole with the aid of water (participants may not chew, divide, dissolve, or crush the study medication)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-Dose, Open-Label, Randomized, 4-Way Crossover Study to Assess the Relative Bioavailability of 3 New Abiraterone Acetate Tablet Formulations With Respect to the Current Commercial Abiraterone Acetate Tablet Under Fasted Conditions in Healthy Male Subjects
The purpose of this study is to evaluate the pharmacokinetics (what the body does to the medication) and relative bioavailability of 3 newly developed abiraterone acetate tablet formulations compared with the current commercial abiraterone acetate tablet formulation in healthy male participants, under fasted conditions, at a single dose of 1000 mg.
Read the detailed description
This is an open-label (all people know the identity of the intervention), randomized (the study medication is assigned by chance), single-center, 4-way crossover study (method used to switch participants from one treatment arm to another in a clinical trial) of a single dose of abiraterone acetate (1000 mg). The study will consist of 3 phases including screening phase (of 21 days), an open-label treatment phase consisting of 4 single-dose treatment periods, and follow-up phase. All participants will be randomly assigned to 1 of 4 possible treatment sequences to ensure that they receive all of the following treatments, one in each period. The 4 sequences are as follows: Sequence 1: Treatment A, D, B, and C; Sequence 2: Treatment B, A, C, and D; Sequence 3: Treatment C, B, D, and A; and Sequence 4: Treatment D, C, A, and B. After a washout period of 7 days, follow-up phase will occur between 5 to 7 days after the last study procedure. The duration of participation in the study for each participant is from 47 days to a maximum of 68 days (including screening). Pharmacokinetics will be measured by collection of blood samples. Participants will be confined to the study center until completion of the 96 hour pharmacokinetic assessments on Day 5 of each treatment period. Safety evaluations for adverse events, clinical laboratory tests, electrocardiogram, vital signs, and physical examinations will be monitored throughout the study.
- Conditions
- Healthy Participants
- Being tested
- Abiraterone acetate, 250 mg (uncoated, current commercial tablet), Abiraterone acetate, 500 mg (coated, reformulated tablet), Abiraterone acetate, 250 mg (coated, reformulated tablet), Abiraterone acetate, 500 mg (coated tablet, slower in vitro dissolution)
- Keywords
- Healthy participants, Bioavailability, Pharmacokinetics, Abiraterone acetate, Abiraterone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abiraterone acetate, 250 mg (uncoated, current commercial tablet)Drug
Also called ZYTIGA
Type=exact number, unit=mg, number=250, form=tablet, route=oral. Administered once under fasted conditions.
Abiraterone acetate, 500 mg (coated, reformulated tablet)Drug
Also called ZYTIGA
Type=exact number, unit=mg, number=500, form=tablet, route=oral. Administered once under fasted conditions.
Abiraterone acetate, 250 mg (coated, reformulated tablet)Drug
Also called ZYTIGA
Type=exact number, unit=mg, number=250, form=tablet, route=oral. Administered once under fasted conditions.
Abiraterone acetate, 500 mg (coated tablet, slower in vitro dissolution)Drug
Also called ZYTIGA
Type=exact number, unit=mg, number=500, form=tablet, route=oral. Administered once under fasted conditions.
| Study group | Role | What they receive |
|---|---|---|
| Treatment B | Experimental | Abiraterone acetate (500 mg), 2 coated, reformulated tablets. Receives: Drug: Abiraterone acetate, 500 mg (coated, reformulated tablet) |
| Treatment C | Experimental | Abiraterone acetate (250 mg), 4 coated, reformulated tablets. Receives: Drug: Abiraterone acetate, 250 mg (coated, reformulated tablet) |
| Treatment D | Experimental | Abiraterone acetate (500 mg), 2 coated, reformulated tablets, showing slower in vitro dissolution. Receives: Drug: Abiraterone acetate, 500 mg (coated tablet, slower in vitro dissolution) |
| Treatment A | Active comparator | Abiraterone acetate (250 mg), 4 uncoated, current commercial tablets. Receives: Drug: Abiraterone acetate, 250 mg (uncoated, current commercial tablet) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum plasma concentration (Cmax) of abiraterone in coated, reformulated tablet compared to abiraterone in uncoated, current commercial tablet
Pharmacokinetic parameter Cmax of abiraterone (coated, reformulated tablet and uncoated, current commercial tablet) will be measured when abiraterone acetate is administered as a single oral 1000-mg dose.
Measured: For each period: Predose, 15 min, 30 min, 1 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 24 hours, 48 hours, 72 hours, and at 96 hours
Area under the plasma concentration versus time curve (AUC) of abiraterone in coated, reformulated tablet compared to abiraterone in uncoated, current commercial tablet
Pharmacokinetic parameter AUC of abiraterone (coated, reformulated tablet and uncoated, current commercial tablet) will be measured when abiraterone acetate is administered as a single oral 1000-mg dose.
Measured: For each period: Predose, 15 min, 30 min, 1 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 24 hours, 48 hours, 72 hours, and at 96 hours
Secondary outcomes (1)
Number of participants with adverse events
Measured: Up to 68 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2012 (estimated)
- Study startMay 2012
- Primary completionJul 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy ParticipantsStudies of the same condition, open and under way.
- More trials run by Janssen Research & Development, LLCThe sponsor's other registered studies.
- 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
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Research & Development, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Research & Development, LLC Clinical Trial, Study director, Janssen Research & Development, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01640093
- Sponsor's protocol ID
- CR100859
- Other IDs
- 212082PCR1006
- Status last verified
- Mar 2013
- First submitted
- 11 Jul 2012
- Last updated
- 4 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Dose, Open-Label, Randomized, 4-Way Crossover Study to Assess the Relative Bioavailability of 3 New Abiraterone Acetate Tablet Formulations With Respect to the Current Commercial Abiraterone Acetate Tablet Under Fasted Conditions in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT01640093
- Acronym / sponsor ID
- CR100859
- Conditions
- Healthy Participants
- Keywords
- Healthy participants, Bioavailability, Pharmacokinetics, Abiraterone acetate, Abiraterone
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
- Study start
- May 2012
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 13 Jul 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 evaluate the pharmacokinetics (what the body does to the medication) and relative bioavailability of 3 newly developed abiraterone acetate tablet formulations compared with the current commercial abiraterone acetate tablet formulation in healthy male participants, under fasted conditions, at a single dose of 1000 mg.
Detailed description
This is an open-label (all people know the identity of the intervention), randomized (the study medication is assigned by chance), single-center, 4-way crossover study (method used to switch participants from one treatment arm to another in a clinical trial) of a single dose of abiraterone acetate (1000 mg). The study will consist of 3 phases including screening phase (of 21 days), an open-label treatment phase consisting of 4 single-dose treatment periods, and follow-up phase. All participants will be randomly assigned to 1 of 4 possible treatment sequences to ensure that they receive all of the following treatments, one in each period. The 4 sequences are as follows: Sequence 1: Treatment A, D, B, and C; Sequence 2: Treatment B, A, C, and D; Sequence 3: Treatment C, B, D, and A; and Sequence 4: Treatment D, C, A, and B. After a washout period of 7 days, follow-up phase will occur between 5 to 7 days after the last study procedure. The duration of participation in the study for each participant is from 47 days to a maximum of 68 days (including screening). Pharmacokinetics will be measured by collection of blood samples. Participants will be confined to the study center until completion of the 96 hour pharmacokinetic assessments on Day 5 of each treatment period. Safety evaluations for adverse events, clinical laboratory tests, electrocardiogram, vital signs, and physical examinations will be monitored throughout the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Treatment B | Experimental | Drug: Abiraterone acetate, 500 mg (coated, reformulated tablet)Abiraterone acetate (500 mg), 2 coated, reformulated tablets. |
| Treatment C | Experimental | Drug: Abiraterone acetate, 250 mg (coated, reformulated tablet)Abiraterone acetate (250 mg), 4 coated, reformulated tablets. |
| Treatment D | Experimental | Drug: Abiraterone acetate, 500 mg (coated tablet, slower in vitro dissolution)Abiraterone acetate (500 mg), 2 coated, reformulated tablets, showing slower in vitro dissolution. |
| Treatment A | Active comparator | Drug: Abiraterone acetate, 250 mg (uncoated, current commercial tablet)Abiraterone acetate (250 mg), 4 uncoated, current commercial tablets. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Have body weight not less than 50 kg
- Must be a non-smoker, and has no history of smoking or use of nicotine-containing substances within the previous 2 months
- Must have blood pressure between 90 and 140 mmHg systolic, inclusive, and no higher than 90 mmHg diastolic
- Must have a 12-lead electrocardiogram consistent with normal cardiac conduction and function
- Must agree to use an adequate contraception method as deemed appropriate by the investigator and to not donate sperm during the study for 3 months after receiving the last dose of study medication
Key exclusion criteria (5 listed)
- History of or current clinically significant medical illness including cardiac arrhythmias or other cardiac disease that could interfere with the interpretation of the study results
- Clinically significant abnormal values for hematology or urinalysis (at screening)
- Clinically significant abnormal physical examination vital signs or 12-lead electrocardiogram (at screening)
- Usage of any prescription or nonprescription medication, except for acetaminophen, and oral contraceptives and hormonal replacement therapy within 14 days before the first dose of the study medication is scheduled
- Unable to swallow solid, oral dosage forms whole with the aid of water (participants may not chew, divide, dissolve, or crush the study medication)
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, 250 mg (uncoated, current commercial tablet)Also: ZYTIGAType=exact number, unit=mg, number=250, form=tablet, route=oral. Administered once under fasted conditions. | Drug | Treatment A |
| Abiraterone acetate, 500 mg (coated, reformulated tablet)Also: ZYTIGAType=exact number, unit=mg, number=500, form=tablet, route=oral. Administered once under fasted conditions. | Drug | Treatment B |
| Abiraterone acetate, 250 mg (coated, reformulated tablet)Also: ZYTIGAType=exact number, unit=mg, number=250, form=tablet, route=oral. Administered once under fasted conditions. | Drug | Treatment C |
| Abiraterone acetate, 500 mg (coated tablet, slower in vitro dissolution)Also: ZYTIGAType=exact number, unit=mg, number=500, form=tablet, route=oral. Administered once under fasted conditions. | Drug | Treatment D |
Primary outcome
Maximum plasma concentration (Cmax) of abiraterone in coated, reformulated tablet compared to abiraterone in uncoated, current commercial tablet
Time frame: For each period: Predose, 15 min, 30 min, 1 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 24 hours, 48 hours, 72 hours, and at 96 hours
Pharmacokinetic parameter Cmax of abiraterone (coated, reformulated tablet and uncoated, current commercial tablet) will be measured when abiraterone acetate is administered as a single oral 1000-mg dose.
Area under the plasma concentration versus time curve (AUC) of abiraterone in coated, reformulated tablet compared to abiraterone in uncoated, current commercial tablet
Time frame: For each period: Predose, 15 min, 30 min, 1 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 24 hours, 48 hours, 72 hours, and at 96 hours
Pharmacokinetic parameter AUC of abiraterone (coated, reformulated tablet and uncoated, current commercial tablet) will be measured when abiraterone acetate is administered as a single oral 1000-mg dose.
1 secondary outcome
Number of participants with adverse events
Time frame: Up to 68 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 4 Mar 2013.
Related trials for Healthy Participants
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
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
RecruitingPhase 1
A Study to Evaluate the Metabolism, the Routes and Extent of Elimination, and Drug Levels of [14C]Navlimetostat (BMS-986504) in Healthy Female Participants
Healthy Female Participants
Not yet recruiting
REM Enhancement Sleep Technology for Well-being, Emotion, and Life Lift
Healthy Adult Participants
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.
Janssen Research & Development, LLC Clinical Trial study director
Janssen Research & Development, LLC
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, 250 mg (uncoated, current commercial tablet), Abiraterone acetate, 500 mg (coated, reformulated tablet) and Abiraterone acetate, 250 mg (coated, reformulated tablet) in people with Healthy Participants, run by Janssen Research & Development, LLC 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 5 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 4 Mar 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 plasma concentration (Cmax) of abiraterone in coated, reformulated tablet compared to abiraterone in uncoated, current commercial tablet (time frame: For each period: Predose, 15 min, 30 min, 1 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 24 hours, 48 hours, 72 hours, and at 96 hours). The study lists 2 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 4 Mar 2013.