Healthy VolunteersPhase 1NCT01588782
A Study to Assess the Effect of Ketoconazole on the Pharmacokinetics of Abiraterone Following Administration of Abiraterone Acetate Tablets in Healthy Adult Men
A Phase 1 study testing Period 1: Abiraterone and Period 2: Abiraterone/Ketoconazole in people with Healthy Volunteers, run by Janssen Research & Development, LLC at 1 site in Belgium.
Trial summary
The purpose of this study is to evaluate the pharmacokinetics, safety, and potential for drug-drug interactions when a strong inhibitor of CYP3A4 (ie, ketoconazole) is co-administered with abiraterone acetate in healthy adult men. 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?
- Period 1: Abiraterone and Period 2: Abiraterone/Ketoconazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteBelgium
- Study dates
- Jan 2012to Feb 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
- Body mass index (BMI) between 18 and 30 kg/m2, inclusive
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 participant or that could interfere with the interpretation of the study results
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-Label Drug-Drug Interaction Study to Assess the Effect of Ketoconazole on the Pharmacokinetics of Abiraterone (JNJ-589485) Following Administration of Abiraterone Acetate (JNJ-212082) Tablets in Healthy Male Subjects
The purpose of this study is to evaluate the pharmacokinetics, safety, and potential for drug-drug interactions when a strong inhibitor of CYP3A4 (ie, ketoconazole) is co-administered with abiraterone acetate in healthy adult men.
Read the detailed description
This is a non-randomized (individuals will not be assigned by chance to study treatments), open-label (individuals will know the identity of study treatments), 2-period, sequential-design, drug-drug interaction study of abiraterone acetate and ketoconazole in approximately 20 healthy adult men. This study will consist of a screening period followed by an open-label treatment phase consisting of 2 treatment periods. Successive drug administration will be separated by a washout period of at least 10 days. All individuals will receive study treatment in the same sequence. Period 1 (Days 1 to 4) consists of a single oral dose of 1000 mg abiraterone acetate tablets on Day 1 only. Period 2 (Days 11 to 17) consists of a daily oral dose of 400 mg ketoconazole tablets on Days 11 to 16 and administration of a single dose of 1000 mg abiraterone acetate on Day 14. Serial pharmacokinetic (study of what the body does to a drug) samples will be collected at each treatment period as detailed in the protocol. Safety will be monitored continuously from the time of informed consent signing until the end of the study.
- Conditions
- Healthy Volunteers
- Being tested
- Period 1: Abiraterone, Period 2: Abiraterone/Ketoconazole
- Keywords
- Healthy volunteers, Pharmacology, Pharmacokinetics, Pharmacodynamics, Drug-drug interactions, CYP3A4, Abiraterone acetate, JNJ-589485, JNJ-212082, Ketoconazole
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Period 1: AbirateroneDrug
1000 mg abiraterone acetate tablet administered orally on Day 1
Period 2: Abiraterone/KetoconazoleDrug
400 mg ketoconazole tablets administered orally on Days 11 to 16
Period 2: Abiraterone/KetoconazoleDrug
1000 mg abiraterone acetate tablet administered orally on Day 14
| Study group | Role | What they receive |
|---|---|---|
| Abiraterone acetate | Experimental | All individuals will receive study treatment in the same sequence. Period 1 (Days 1 to 4) consists of a single oral dose of 1000 mg abiraterone acetate tablets on Day 1 only. Period 2 (Days 11 to 17) consists of a daily oral dose of 400 mg ketoconazole tablets on Days 11 to 16 and administration of a single dose of 1000 mg abiraterone acetate on Day 14. Receives: Drug: Period 1: Abiraterone; Drug: Period 2: Abiraterone/Ketoconazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean plasma concentrations of abiraterone
Measured: Up to Day 17
Mean plasma concentrations of ketoconazole
Measured: Up to Day 14
Maximum plasma concentrations of abiraterone
Measured: Up to Day 17
Time to reach the maximum plasma concentration of abiraterone
Measured: Up to Day 17
Area under the plasma concentration-time curve from time 0 to time to the last quantifiable concentration of abiraterone
Measured: Up to Day 17
Area under the plasma concentration-time curve from time 0 to infinite time of abiraterone
Measured: Up to Day 17
Elimination half-life associated with the terminal slope of the semilogarithmic drug concentration-time curve of abiraterone
Measured: Up to Day 17
First-order rate constant associated with the terminal portion of the curve of abiraterone
Measured: Up to Day 17
Time to last quantifiable plasma concentration of abiraterone
Measured: Up to Day 17
Percentage of area under the plasma concentration-time curve from time 0 to infinite time obtained by extrapolation of abiraterone
Measured: Up to Day 17
Secondary outcomes (1)
The number of participants affected by an adverse event
Measured: Up to end of study or early withdrawal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2012 (estimated)
- Study startJan 2012
- Primary completionFeb 2012
- Study completionFeb 2012
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.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 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
- NCT01588782
- Sponsor's protocol ID
- CR100650
- Other IDs
- 212082PCR1002
- Status last verified
- Nov 2012
- First submitted
- 9 Jan 2012
- 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
- An Open-Label Drug-Drug Interaction Study to Assess the Effect of Ketoconazole on the Pharmacokinetics of Abiraterone (JNJ-589485) Following Administration of Abiraterone Acetate (JNJ-212082) Tablets in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT01588782
- Acronym / sponsor ID
- CR100650
- Conditions
- Healthy Volunteers
- Keywords
- Healthy volunteers, Pharmacology, Pharmacokinetics, Pharmacodynamics, Drug-drug interactions, CYP3A4, Abiraterone acetate, JNJ-589485
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
- Study start
- Jan 2012
- Primary completion
- Feb 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 1 May 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, safety, and potential for drug-drug interactions when a strong inhibitor of CYP3A4 (ie, ketoconazole) is co-administered with abiraterone acetate in healthy adult men.
Detailed description
This is a non-randomized (individuals will not be assigned by chance to study treatments), open-label (individuals will know the identity of study treatments), 2-period, sequential-design, drug-drug interaction study of abiraterone acetate and ketoconazole in approximately 20 healthy adult men. This study will consist of a screening period followed by an open-label treatment phase consisting of 2 treatment periods. Successive drug administration will be separated by a washout period of at least 10 days. All individuals will receive study treatment in the same sequence. Period 1 (Days 1 to 4) consists of a single oral dose of 1000 mg abiraterone acetate tablets on Day 1 only. Period 2 (Days 11 to 17) consists of a daily oral dose of 400 mg ketoconazole tablets on Days 11 to 16 and administration of a single dose of 1000 mg abiraterone acetate on Day 14. Serial pharmacokinetic (study of what the body does to a drug) samples will be collected at each treatment period as detailed in the protocol. Safety will be monitored continuously from the time of informed consent signing until the end of 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: Period 1: Abiraterone, Drug: Period 2: Abiraterone/KetoconazoleAll individuals will receive study treatment in the same sequence. Period 1 (Days 1 to 4) consists of a single oral dose of 1000 mg abiraterone acetate tablets on Day 1 only. Period 2 (Days 11 to 17) consists of a daily oral dose of 400 mg ketoconazole tablets on Days 11 to 16 and administration of a single dose of 1000 mg abiraterone acetate on Day 14. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Body mass index (BMI) between 18 and 30 kg/m2, inclusive
Key exclusion criteria (1 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 participant or that could interfere with the interpretation of the study results
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 |
|---|---|---|
| Period 1: Abiraterone1000 mg abiraterone acetate tablet administered orally on Day 1 | Drug | Abiraterone acetate |
| Period 2: Abiraterone/Ketoconazole400 mg ketoconazole tablets administered orally on Days 11 to 16 | Drug | Abiraterone acetate |
| Period 2: Abiraterone/Ketoconazole1000 mg abiraterone acetate tablet administered orally on Day 14 | Drug | Abiraterone acetate |
Primary outcome
Mean plasma concentrations of abiraterone
Time frame: Up to Day 17
Mean plasma concentrations of ketoconazole
Time frame: Up to Day 14
Maximum plasma concentrations of abiraterone
Time frame: Up to Day 17
Time to reach the maximum plasma concentration of abiraterone
Time frame: Up to Day 17
Area under the plasma concentration-time curve from time 0 to time to the last quantifiable concentration of abiraterone
Time frame: Up to Day 17
Area under the plasma concentration-time curve from time 0 to infinite time of abiraterone
Time frame: Up to Day 17
Elimination half-life associated with the terminal slope of the semilogarithmic drug concentration-time curve of abiraterone
Time frame: Up to Day 17
First-order rate constant associated with the terminal portion of the curve of abiraterone
Time frame: Up to Day 17
Time to last quantifiable plasma concentration of abiraterone
Time frame: Up to Day 17
Percentage of area under the plasma concentration-time curve from time 0 to infinite time obtained by extrapolation of abiraterone
Time frame: Up to Day 17
1 secondary outcome
The number of participants affected by an adverse event
Time frame: Up to end of study or early withdrawal
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.
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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.
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 Period 1: Abiraterone and Period 2: Abiraterone/Ketoconazole in people with Healthy Volunteers, run by Janssen Research & Development, LLC at 1 site in Belgium.
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 1 inclusion and 1 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.
Where is the study taking place?
The record lists 1 site in Belgium. 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?
Mean plasma concentrations of abiraterone (time frame: Up to Day 17). The study lists 10 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 27 Nov 2012.