PharmacologyPhase 1NCT01575587

A Study to Assess the Effect of Timing of Food Intake on the Pharmacokinetics of Abiraterone Following Single-Dose Administration of Abiraterone Acetate Tablets in Healthy Caucasian and Japanese Men

A Phase 1 study testing Abiraterone: Treatment A, Abiraterone: Treatment B and Abiraterone: Treatment C in people with Pharmacology, run by Janssen Research & Development, LLC at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to evaluate the effect of timing of food intake on systemic abiraterone exposure observed in healthy adult Japanese and Caucasian men. Read more about this study

Who is it for?: Ages 25 to 35 years, men onlyHealthy volunteers can take part
Conditions the study is for: Pharmacology
What is being tested?: Abiraterone: Treatment A, Abiraterone: Treatment B and Abiraterone: Treatment C
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 51 participants
Where: 1 siteUnited States
Study dates: Jan 2012to May 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 25 to 35 years
Men only
Healthy volunteers accepted
Adult

Who may be able to join

Healthy Caucasian and Japanese male individuals.
Body mass index between 18 and 30 kg/m2.
Body weight >=50 kg.
A normal 12-lead electrocardiogram.

Who cannot join

History of or current clinically significant medical illness that the investigator considers should exclude the participant or that could interfere with the interpretation of the study results.
Presence of sexual dysfunction (abnormal libido, erectile dysfunction, etc.) or any medical condition that would affect sexual function.
History of alcohol consumption of more than 4 drinks daily within 1 year prior to screening and unwillingness to abstain from alcohol-containing food or beverages from within 24 hours before Day-1 through study completion.
History of, or a reason to believe a participant has a history of drug or alcohol abuse within the past 5 years.
Positive test for human immunodeficiency virus 1 and 2 antibodies, hepatitis B surface antigen, or hepatitis C antibodies.
History of smoking or use of nicotine-containing substances within the previous 2 months, as determined by medical history or participant's verbal report.

Trial locations and contacts

1 site in 1 country.

United States1 site

Study site
Cypress, California

Other trials in United States

About this study

Official title: A Single-Dose, Open-Label, Randomized, 4-Way Crossover Study to Assess the Effect of Timing of Food Intake on the Pharmacokinetics of Abiraterone Following Single-Dose Administration of Abiraterone Acetate Tablets in Healthy Caucasian and Japanese Male Subjects

The purpose of this study is to evaluate the effect of timing of food intake on systemic abiraterone exposure observed in healthy adult Japanese and Caucasian men.

Read the detailed description

This is a randomized (individuals will be assigned by chance to study treatments), open-label (individuals will know the identity of study treatments), single dose, 4-way crossover study of abiraterone acetate in approximately 48 healthy adult Japanese and Caucasian men. For the crossover design, the treatment sequences are defined as follows: 1 - ADBC, 2 - BACD, 3 - CBDA, and 4 - DCAB; where Treatment A = abiraterone acetate administered in the fasted state, Treatment B = standardized meal administered 1 hour after abiraterone acetate dose, Treatment C = standardized meal administered 2 hours after abiraterone acetate dose, and Treatment D = standardized meal administered 2 hours before and 2 hours after abiraterone acetate dose. This study will consist of a screening period followed by four open-label treatment periods separated by a washout period of at least 14 days between dosing. Eligible participants will be randomly assigned on Day 1 to 1 of 4 treatment sequences that differ with regard to timing of food intake before and/or after dosing with a single dose of 1000 mg of abiraterone acetate. Serial pharmacokinetic (study of what the body does to a drug) samples will be collected during the open-label treatment phase as detailed in the protocol. Safety will be monitored throughout the study. End-of-study assessments will be performed on Day 4 of Period 4 or upon early withdrawal.

Conditions: Pharmacology
Being tested: Abiraterone: Treatment A, Abiraterone: Treatment B, Abiraterone: Treatment C, Abiraterone: Treatment D
Keywords: Pharmacology, Pharmacokinetics, Pharmacodynamics, Abiraterone acetate, Food intake, Caucasion, Japanese, Healthy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Abiraterone: Treatment ADrug
1000 mg abiraterone acetate administered in the fasting state
Abiraterone: Treatment BDrug
Standardized meal administered 1 hour after the 1000 mg abiraterone acetate dose
Abiraterone: Treatment CDrug
Standardized meal administered 2 hours before the 1000 mg abiraterone acetate dose
Abiraterone: Treatment DDrug
Standardized meal administered 2 hours before and 2 hours after the 1000 mg abiraterone acetate dose

Study groups in NCT01575587
Study group	Role	What they receive
Treatment A	Experimental	Not described Receives: Drug: Abiraterone: Treatment A
Treatment B	Experimental	Not described Receives: Drug: Abiraterone: Treatment B
Treatment C	Experimental	Not described Receives: Drug: Abiraterone: Treatment C
Treatment D	Experimental	Not described Receives: Drug: Abiraterone: Treatment D

What is being measured

The primary outcome is the main question the study is designed to answer.

Changes in mean plasma concentrations of abiraterone
Measured: Up to Day 4, treatment period 4

Secondary outcomes (10)

Mean plasma concentrations of abiraterone
Measured: Up to Day 4, treatment period 4
Maximum plasma concentration of abiraterone
Measured: Up to Day 4, treatment period 4
Time to reach the maximum plasma concentration of abiraterone
Measured: Up to Day 4, treatment period 4
Area under the plasma concentration-time curve from time 0 to time the last quantifiable concentration of abiraterone
Measured: Up to Day 4, treatment period 4
Area under the plasma concentration-time curve from time 0 to infinite time of abiraterone
Measured: Up to Day 4, treatment period 4
Elimination half-life associated with the terminal slope of the semilogarithmic drug concentration-time curve of abiraterone
Measured: Up to Day 4, treatment period 4
First-order rate constant associated with the terminal portion of the curve of abiraterone
Measured: Up to Day 4, treatment period 4
Time to last quantifiable plasma concentration of abiraterone
Measured: Up to Day 4, treatment period 4
Percentage of area under the plasma concentration-time curve from time 0 to infinite time obtained by extrapolation of abiraterone
Measured: Up to Day 4, treatment period 4
The number of participants affected by an adverse event
Measured: Up to the end of the study (4 days after final dose of study drug) or early withdrawal

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2012May 2012

First posted11 Apr 2012 (estimated)
Study startJan 2012
Primary completionMay 2012
Study completionMay 2012

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 PharmacologyStudies 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: 51 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01575587
Sponsor's protocol ID: CR100737
Other IDs: 212082PCR1005
Status last verified: Jan 2014
First submitted: 19 Jan 2012
Last updated: 10 Jan 2014
Results posted: No
Data monitoring committee: No

Publications

Inoue K, Shishido A, Vaccaro N, Jiao J, Stieltjes H, Bernard A, Yu M, Chien C. Pharmacokinetics of abiraterone in healthy Japanese men: dose-proportionality and effect of food timing. Cancer Chemother Pharmacol. 2015 Jan;75(1):49-58. doi: 10.1007/s00280-014-2616-4. Epub 2014 Oct 25.
PubMed 25344090

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 10 Jan 2014. 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 Effect of Timing of Food Intake on the Pharmacokinetics of Abiraterone Following Single-Dose Administration of Abiraterone Acetate Tablets in Healthy Caucasian and Japanese Male Subjects
ClinicalTrials.gov ID: NCT01575587
Acronym / sponsor ID: CR100737
Conditions: Pharmacology
Keywords: Pharmacology, Pharmacokinetics, Pharmacodynamics, Abiraterone acetate, Food intake, Caucasion, Japanese, Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 51 participants (actual)
Lead sponsor: Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
Study start: Jan 2012
Primary completion: May 2012 (actual)
Study completion: May 2012 (actual)
First posted: 11 Apr 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 effect of timing of food intake on systemic abiraterone exposure observed in healthy adult Japanese and Caucasian men.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
Treatment A	Experimental	Drug: Abiraterone: Treatment A
Treatment B	Experimental	Drug: Abiraterone: Treatment B
Treatment C	Experimental	Drug: Abiraterone: Treatment C
Treatment D	Experimental	Drug: Abiraterone: Treatment D

Who may qualify

Ages: 25 to 35 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (4 listed)

Healthy Caucasian and Japanese male individuals.
Body mass index between 18 and 30 kg/m2.
Body weight >=50 kg.
A normal 12-lead electrocardiogram.

Key exclusion criteria (6 listed)

History of or current clinically significant medical illness that the investigator considers should exclude the participant or that could interfere with the interpretation of the study results.
Presence of sexual dysfunction (abnormal libido, erectile dysfunction, etc.) or any medical condition that would affect sexual function.
History of alcohol consumption of more than 4 drinks daily within 1 year prior to screening and unwillingness to abstain from alcohol-containing food or beverages from within 24 hours before Day-1 through study completion.
History of, or a reason to believe a participant has a history of drug or alcohol abuse within the past 5 years.
Positive test for human immunodeficiency virus 1 and 2 antibodies, hepatitis B surface antigen, or hepatitis C antibodies.

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: Treatment A1000 mg abiraterone acetate administered in the fasting state	Drug	Treatment A
Abiraterone: Treatment BStandardized meal administered 1 hour after the 1000 mg abiraterone acetate dose	Drug	Treatment B
Abiraterone: Treatment CStandardized meal administered 2 hours before the 1000 mg abiraterone acetate dose	Drug	Treatment C
Abiraterone: Treatment DStandardized meal administered 2 hours before and 2 hours after the 1000 mg abiraterone acetate dose	Drug	Treatment D

Primary outcome

Changes in mean plasma concentrations of abiraterone
Time frame: Up to Day 4, treatment period 4

10 secondary outcomes

Mean plasma concentrations of abiraterone
Time frame: Up to Day 4, treatment period 4
Maximum plasma concentration of abiraterone
Time frame: Up to Day 4, treatment period 4
Time to reach the maximum plasma concentration of abiraterone
Time frame: Up to Day 4, treatment period 4
Area under the plasma concentration-time curve from time 0 to time the last quantifiable concentration of abiraterone
Time frame: Up to Day 4, treatment period 4
Area under the plasma concentration-time curve from time 0 to infinite time of abiraterone
Time frame: Up to Day 4, treatment period 4
Elimination half-life associated with the terminal slope of the semilogarithmic drug concentration-time curve of abiraterone
Time frame: Up to Day 4, treatment period 4
First-order rate constant associated with the terminal portion of the curve of abiraterone
Time frame: Up to Day 4, treatment period 4
Time to last quantifiable plasma concentration of abiraterone
Time frame: Up to Day 4, treatment period 4
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 4, treatment period 4
The number of participants affected by an adverse event
Time frame: Up to the end of the study (4 days after final dose of study drug) 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 10 Jan 2014.
Derived from this study: PubMed 25344090Inoue K, Shishido A, Vaccaro N, Jiao J, Stieltjes H, Bernard A, Yu M, Chien C. Pharmacokinetics of abiraterone in healthy Japanese men: dose-proportionality and effect of food timing. Cancer Chemother Pharmacol. 2015 Jan;75(1):49-58. doi: 10.1007/s00280-014-2616-4. Epub 2014 Oct 25.

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Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
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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?

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 4 inclusion and 6 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 10 Jan 2014. 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?

Changes in mean plasma concentrations of abiraterone (time frame: Up to Day 4, treatment period 4). 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 NCT01575587, 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 10 Jan 2014.