Healthy VolunteersPhase 1NCT01873001

A Study to Assess the Effect of Abiraterone (JNJ-589485) on the Pharmacokinetics of Pioglitazone Following Administration of Abiraterone Acetate (JNJ-212082) and Pioglitazone HCl Tablets in Healthy Male Participants

A Phase 1 study testing Pioglitazone HCl and Abiraterone acetate in people with Healthy Volunteers, run by Janssen Research & Development, LLC at 1 site in Belgium.

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 effects of abiraterone on the pharmacokinetics (study of what the body does to a drug) of pioglitazone when coadministered with abiraterone acetate in healthy adult male participants. 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?: Pioglitazone HCl and Abiraterone acetate
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 16 participants
Where: 1 siteBelgium
Study dates: May 2013to Jul 2013
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

Agrees to protocol-defined use of effective contraception for 1 week after receiving the last dose of study drug
Agrees to not donate sperm during the study and for 1 week after receiving the last dose of study drug
Body mass index between 18 and 30 kg/m2 and body weight not less than 50 kg
Blood pressure between 90 and 140 mmHg systolic, and no higher than 90 mmHg diastolic
A 12-lead electrocardiogram consistent with normal cardiac conduction and function
Non-smoker
Laboratory values within protocol -defined parameters

Who cannot join

History of or current clinically significant medical illness
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
Presence of sexual dysfunction or any medical condition that would affect sexual function
Clinically significant abnormal physical examination, vital signs, or 12-lead electrocardiogram
Use of any prescription or nonprescription medication (including vitamins and herbal supplements) before the first dose of the study drug is scheduled through study completion
History of drug or alcohol abuse within 3 years before screening or positive test result(s) for alcohol and/or drugs of abuse at screening and Day -1 and at Day 7 of the treatment period

Show all 12Show fewer

Known allergy to the study drug or any of the excipients of the formulation
History of stomach or intestinal surgery or resection that would potentially alter absorption or excretion of orally administered drugs (appendectomy and hernia repair will be allowed)
Donated blood or blood products or had substantial loss of blood within 3 months before the first administration of study drug or intention to donate blood or blood products during the study
Received an experimental drug or used an experimental medical device within 1 month or within a period less than 10 times the drug's half-life, whichever is longer, before the first dose of the study drug is scheduled
Positive test for human immunodeficiency virus 1 and 2 antibodies, hepatitis B surface antigen, hepatitis B core antibody or hepatitis C antibodies
Preplanned surgery or procedures that would interfere with the conduct of the study

Trial locations and contacts

1 site in 1 country.

Belgium1 site

Study site
Merksem

Other trials in Belgium

About this study

Official title: An Open-Label Drug-Drug Interaction Study to Assess the Effect of Abiraterone (JNJ-589485) on the Pharmacokinetics of Pioglitazone Following Administration of Abiraterone Acetate (JNJ-212082) and Pioglitazone HCl Tablets in Healthy Male Subjects

Read the detailed description

This is an open-label (identity of assigned study drug will be known) single-dose drug-drug interaction study to assess the effect of abiraterone on pioglitazone. Approximately 16 healthy adult male participants will be enrolled in this study. The study consists of a screening phase, an open-label treatment phase consisting of 2 single-dose treatment periods, end-of-study or withdrawal assessments done upon completion of the 72-hour pharmacokinetic sampling on Day 11 of Period 2 or upon withdrawal, and a follow-up visit 5 to 7 days after the last study procedure. The total study length is 32 days. Participants will receive pioglitazone alone on Day 1 (Period 1) of the study. On Day 8 (Period 2), participants will receive a single dose of abiraterone acetate followed by a single dose of pioglitazone one hour later. Successive pioglitazone administrations will be separated by a washout period of 7 days. Participants will be confined to the study center from Day -1 to Day 4 of Period 1 and from Day 7 to Day 11 of Period 2, at least 10 hours before each study drug administration until completion of the 72-hour blood sample collection for each period. A pharmacogenomic blood sample will be collected from all participants on Day -1. Safety will be monitored throughout the study.

Conditions: Healthy Volunteers
Being tested: Pioglitazone HCl, Abiraterone acetate
Keywords: Healthy volunteers, Drug-drug Interaction, Pharmacokinetics, Abiraterone, JNJ-589485, Abiraterone acetate, JNJ-212082, Pioglitazone HCl

What participants receive

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

Pioglitazone HClDrug
15 mg tablet administered by mouth on Day 1, and Day 8 1 hour after study drug administration
Abiraterone acetateDrug
1000 mg tablets administered by mouth on Day 8

Study groups in NCT01873001
Study group	Role	What they receive
Abiraterone acetate + pioglitazone HCl	Experimental	Participants will receive 15 mg pioglitazone on Day 1 (Period 1). On Day 8 (Period 2), participants will receive 1000 mg abiraterone acetate followed by 15 mg of pioglitazone one hour later. Receives: Drug: Pioglitazone HCl; Drug: Abiraterone acetate

What is being measured

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

Maximum observed plasma concentration of pioglitazone
Measured: Day 1 and Day 8 predose, and postdose at 30 min, 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 24 h, 36 h, 48 h, 72 h
Time to reach the maximum observed plasma concentration of pioglitazone
Measured: Day 1 and Day 8 predose, and postdose at 30 min, 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 24 h, 36 h, 48 h, 72 h
Area under the plasma concentration-time curve from time 0 to time of the last observed quantifiable concentration of pioglitazone
Measured: Day 1 and Day 8 predose, and postdose at 30 min, 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 24 h, 36 h, 48 h, 72 h
Area under the plasma concentration-time curve from time 0 to infinite time of pioglitazone
Measured: Day 1 and Day 8 predose, and postdose at 30 min, 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 24 h, 36 h, 48 h, 72 h
Percentage of area under the plasma concentration time curve obtained by extrapolation of pioglitazone
Measured: Day 1 and Day 8 predose, and postdose at 30 min, 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 24 h, 36 h, 48 h, 72 h
Elimination half-life associated with the terminal slope of the semilogarithmic drug concentration-time curve of pioglitazone
Measured: Day 1 and Day 8 predose, and postdose at 30 min, 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 24 h, 36 h, 48 h, 72 h
Time to last observed quantifiable plasma concentration of pioglitazone
Measured: Day 1 and Day 8 predose, and postdose at 30 min, 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 24 h, 36 h, 48 h, 72 h

Secondary outcomes (12)

Maximum observed plasma concentration of abiraterone
Measured: Day 8 predose, and postdose at 30 min, 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 24 h, 36 h, 48 h, 72 h
Time to reach the maximum observed plasma concentration of abiraterone
Measured: Day 8 predose, and postdose at 30 min, 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 24 h, 36 h, 48 h, 72 h
Area under the plasma concentration-time curve from time 0 to time of the last observed quantifiable concentration of abiraterone
Measured: Day 8 predose, and postdose at 30 min, 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 24 h, 36 h, 48 h, 72 h
Area under the plasma concentration-time curve from time 0 to infinite time of abiraterone
Measured: Day 8 predose, and postdose at 30 min, 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 24 h, 36 h, 48 h, 72 h
Percentage of area under the plasma concentration-time curve obtained by extrapolation of abiraterone
Measured: Day 8 predose, and postdose at 30 min, 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 24 h, 36 h, 48 h, 72 h
Elimination half-life associated with the terminal slope of the semilogarithmic drug concentration-time curve of abiraterone
Measured: Day 8 predose, and postdose at 30 min, 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 24 h, 36 h, 48 h, 72 h
Time to last observed quantifiable plasma concentration of abiraterone
Measured: Day 8 predose, and postdose at 30 min, 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 24 h, 36 h, 48 h, 72 h
Apparent total plasma clearance of drug after extravascular administration of pioglitazone
Measured: Day 8 predose, and postdose at 30 min, 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 24 h, 36 h, 48 h, 72 h
Metabolite to parent drug ratio for maximum observed plasma concentration
Measured: Day 1 and Day 8 predose, and postdose at 30 min, 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 24 h, 36 h, 48 h, 72 h
Metabolite to parent drug ratio for area under the plasma concentration time curve from time 0 to time of the last observed quantifiable concentration
Measured: Day 1 and Day 8 predose, and postdose at 30 min, 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 24 h, 36 h, 48 h, 72 h
Metabolite to parent drug ratio for area under the plasma concentration time curve from time 0 to infinite time
Measured: Day 1 and Day 8 predose, and postdose at 30 min, 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 24 h, 36 h, 48 h, 72 h
Number of participants affected by adverse events by MedDRA system organ class (SOC) and Preferred term (PT)
Measured: Up to 30 days after the last dose of study medication

Timeline

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

May 2013Jul 2013

First posted7 Jun 2013 (estimated)
Study startMay 2013
Primary completionJul 2013
Study completionJul 2013

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: 16 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01873001
Sponsor's protocol ID: CR101970
Other IDs: 212082PCR1011, 2013-001408-12
Status last verified: Apr 2014
First submitted: 5 Jun 2013
Last updated: 17 Apr 2014
Results posted: No
Data monitoring committee: No

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?

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Study at a glance

From the registry record, last updated by the sponsor on 17 Apr 2014. 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 Abiraterone (JNJ-589485) on the Pharmacokinetics of Pioglitazone Following Administration of Abiraterone Acetate (JNJ-212082) and Pioglitazone HCl Tablets in Healthy Male Subjects
ClinicalTrials.gov ID: NCT01873001
Acronym / sponsor ID: CR101970
Conditions: Healthy Volunteers
Keywords: Healthy volunteers, Drug-drug Interaction, Pharmacokinetics, Abiraterone, JNJ-589485, Abiraterone acetate, JNJ-212082, Pioglitazone HCl
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 16 participants (actual)
Lead sponsor: Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
Study start: May 2013
Primary completion: Jul 2013 (actual)
Study completion: Jul 2013 (actual)
First posted: 7 Jun 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.

Detailed description

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 + pioglitazone HCl	Experimental	Drug: Pioglitazone HCl, Drug: Abiraterone acetateParticipants will receive 15 mg pioglitazone on Day 1 (Period 1). On Day 8 (Period 2), participants will receive 1000 mg abiraterone acetate followed by 15 mg of pioglitazone one hour later.

Who may qualify

Ages: 18 to 55 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (7 listed)

Agrees to protocol-defined use of effective contraception for 1 week after receiving the last dose of study drug
Agrees to not donate sperm during the study and for 1 week after receiving the last dose of study drug
Body mass index between 18 and 30 kg/m2 and body weight not less than 50 kg
Blood pressure between 90 and 140 mmHg systolic, and no higher than 90 mmHg diastolic
A 12-lead electrocardiogram consistent with normal cardiac conduction and function

Key exclusion criteria (12 listed)

History of or current clinically significant medical illness
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
Presence of sexual dysfunction or any medical condition that would affect sexual function
Clinically significant abnormal physical examination, vital signs, or 12-lead electrocardiogram
Use of any prescription or nonprescription medication (including vitamins and herbal supplements) before the first dose of the study drug is scheduled through study completion

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
Pioglitazone HCl15 mg tablet administered by mouth on Day 1, and Day 8 1 hour after study drug administration	Drug	Abiraterone acetate + pioglitazone HCl
Abiraterone acetate1000 mg tablets administered by mouth on Day 8	Drug	Abiraterone acetate + pioglitazone HCl

Primary outcome

Maximum observed plasma concentration of pioglitazone
Time frame: Day 1 and Day 8 predose, and postdose at 30 min, 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 24 h, 36 h, 48 h, 72 h
Time to reach the maximum observed plasma concentration of pioglitazone
Time frame: Day 1 and Day 8 predose, and postdose at 30 min, 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 24 h, 36 h, 48 h, 72 h
Area under the plasma concentration-time curve from time 0 to time of the last observed quantifiable concentration of pioglitazone
Time frame: Day 1 and Day 8 predose, and postdose at 30 min, 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 24 h, 36 h, 48 h, 72 h
Area under the plasma concentration-time curve from time 0 to infinite time of pioglitazone
Time frame: Day 1 and Day 8 predose, and postdose at 30 min, 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 24 h, 36 h, 48 h, 72 h
Percentage of area under the plasma concentration time curve obtained by extrapolation of pioglitazone
Time frame: Day 1 and Day 8 predose, and postdose at 30 min, 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 24 h, 36 h, 48 h, 72 h
Elimination half-life associated with the terminal slope of the semilogarithmic drug concentration-time curve of pioglitazone
Time frame: Day 1 and Day 8 predose, and postdose at 30 min, 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 24 h, 36 h, 48 h, 72 h
Time to last observed quantifiable plasma concentration of pioglitazone
Time frame: Day 1 and Day 8 predose, and postdose at 30 min, 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 24 h, 36 h, 48 h, 72 h

12 secondary outcomes

Maximum observed plasma concentration of abiraterone
Time frame: Day 8 predose, and postdose at 30 min, 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 24 h, 36 h, 48 h, 72 h
Time to reach the maximum observed plasma concentration of abiraterone
Time frame: Day 8 predose, and postdose at 30 min, 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 24 h, 36 h, 48 h, 72 h
Area under the plasma concentration-time curve from time 0 to time of the last observed quantifiable concentration of abiraterone
Time frame: Day 8 predose, and postdose at 30 min, 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 24 h, 36 h, 48 h, 72 h
Area under the plasma concentration-time curve from time 0 to infinite time of abiraterone
Time frame: Day 8 predose, and postdose at 30 min, 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 24 h, 36 h, 48 h, 72 h
Percentage of area under the plasma concentration-time curve obtained by extrapolation of abiraterone
Time frame: Day 8 predose, and postdose at 30 min, 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 24 h, 36 h, 48 h, 72 h
Elimination half-life associated with the terminal slope of the semilogarithmic drug concentration-time curve of abiraterone
Time frame: Day 8 predose, and postdose at 30 min, 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 24 h, 36 h, 48 h, 72 h
Time to last observed quantifiable plasma concentration of abiraterone
Time frame: Day 8 predose, and postdose at 30 min, 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 24 h, 36 h, 48 h, 72 h
Apparent total plasma clearance of drug after extravascular administration of pioglitazone
Time frame: Day 8 predose, and postdose at 30 min, 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 24 h, 36 h, 48 h, 72 h
Metabolite to parent drug ratio for maximum observed plasma concentration
Time frame: Day 1 and Day 8 predose, and postdose at 30 min, 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 24 h, 36 h, 48 h, 72 h
Metabolite to parent drug ratio for area under the plasma concentration time curve from time 0 to time of the last observed quantifiable concentration
Time frame: Day 1 and Day 8 predose, and postdose at 30 min, 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 24 h, 36 h, 48 h, 72 h
Metabolite to parent drug ratio for area under the plasma concentration time curve from time 0 to infinite time
Time frame: Day 1 and Day 8 predose, and postdose at 30 min, 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 24 h, 36 h, 48 h, 72 h
Number of participants affected by adverse events by MedDRA system organ class (SOC) and Preferred term (PT)
Time frame: Up to 30 days after the last dose of study medication

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 17 Apr 2014.

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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 Pioglitazone HCl and Abiraterone acetate 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 7 inclusion and 12 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 17 Apr 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 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?

Maximum observed plasma concentration of pioglitazone (time frame: Day 1 and Day 8 predose, and postdose at 30 min, 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 24 h, 36 h, 48 h, 72 h). The study lists 7 primary outcomes in all. 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 NCT01873001.

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 17 Apr 2014.