HealthyPhase 1NCT01678573
A Study to Evaluate the Pharmacokinetics of Abiraterone in Healthy Chinese Male Participants
A Phase 1 study testing Treatment A: abiraterone acetate, Treatment B: abiraterone acetate and Treatment C: abiraterone acetate in people with Healthy, run by Janssen Research & Development, LLC at 1 site in China.
Trial summary
The purpose of this study is to evaluate the pharmacokinetics (how the drug concentrations change over time) of abiraterone acetate after oral administration of abiraterone acetate at different dose levels of 250, 500, and 1000 mg in healthy Chinese male participants under fasted conditions. 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
- What is being tested?
- Treatment A: abiraterone acetate, Treatment B: abiraterone acetate and Treatment C: abiraterone acetate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteChina
- Study dates
- Jul 2012to Sep 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 within 18 to 27 kg/m2 (inclusive) and body weight above 50 kg at screening
- Protocol-defined laboratory and electrocardiogram parameters
- Negative test results for selected medications and substances of abuse and negative exhaled carbon monoxide test at check-in day of each period
- Agrees to protocol-defined use of effective contraception
- Willing to be confined at the clinical research facility for time period specified in the protocol
Who cannot join
- Significant history or current manifestation of any significant metabolic, allergic, dermatological, hepatic, renal, hematologic, pulmonary, cardiovascular, gastrointestinal, neurological, or psychiatric disorder
- History of hypersensitivity reaction to the study medication or related compounds or excipients used in the formulation
- Confirmed hepatitis A, B, or C infection or human immunodeficiency virus (HIV) 1 or HIV-2 infection at screening
- Serum testosterone level of <200 ng/dL
- Use of any tobacco or nicotine-containing products
- Known or suspected use of illicit drugs in the last year
- Protocol contraindicated medications/preparations (prescription and non-prescription)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-Dose, Randomized, Open-Label, Three-Way Crossover Study to Evaluate the Pharmacokinetics of Abiraterone in Chinese Healthy Male Subjects
The purpose of this study is to evaluate the pharmacokinetics (how the drug concentrations change over time) of abiraterone acetate after oral administration of abiraterone acetate at different dose levels of 250, 500, and 1000 mg in healthy Chinese male participants under fasted conditions.
Read the detailed description
This is an open-label (all people know the identity of the intervention), randomized (the treatment sequence is assigned by chance), 3-way crossover study (method used to switch participants from one dose level to another in a clinical study) of single doses of abiraterone acetate in healthy Chinese male participants. The study consists of 3 phases: screening, open-label treatment, and follow up phases. After screening, randomly assigned participants will receive different dose levels of abiraterone acetate (Treatment A = 250 mg; Treatment B = 500 mg; and Treatment C = 1000 mg) on Day 1 in each of the 3 treatment periods according to a randomized schedule under fasted conditions (Sequence 1 = ABC; Sequence 2 = BAC; and Sequence 3 = CBA). Each treatment period will be separated by a washout period (period when participant is not receiving any study medication) of at least 7 days. In the follow-up phase, study-related adverse events will be monitored by the investigator. Serial blood samples for pharmacokinetic analysis will be collected and safety will be monitored throughout the study. The total study duration will be approximately 42 days.
- Conditions
- Healthy
- Being tested
- Treatment A: abiraterone acetate, Treatment B: abiraterone acetate, Treatment C: abiraterone acetate
- Keywords
- Healthy, Pharmacokinetics, Abiraterone acetate, Abiraterone, JNJ-212082, Zytiga, Chinese, Fasted
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment A: abiraterone acetateDrug
Also called ZYTIGA
250 mg/day tablet administered orally on Day 1 of each treatment period.
Treatment B: abiraterone acetateDrug
Also called ZYTIGA
500 mg/day tablets administered orally on Day 1 of each treatment period.
Treatment C: abiraterone acetateDrug
Also called ZYTIGA
1000 mg/day tablets administered orally on Day 1 of each treatment period.
| Study group | Role | What they receive |
|---|---|---|
| Sequence 1: abiraterone acetate | Experimental | Randomly assigned participants in Sequence 1 will receive different dose levels of abiraterone acetate (Treatment A = 250 mg; Treatment B = 500 mg; and Treatment C = 1000 mg) on Day 1 in each of the 3 treatment periods according to the randomized schedule "ABC" under fasted conditions. Receives: Drug: Treatment A: abiraterone acetate; Drug: Treatment B: abiraterone acetate; Drug: Treatment C: abiraterone acetate |
| Sequence 2: abiraterone acetate | Experimental | Randomly assigned participants in Sequence 2 will receive different dose levels of abiraterone acetate (Treatment A = 250 mg; Treatment B = 500 mg; and Treatment C = 1000 mg) on Day 1 in each of the 3 treatment periods according to the randomized schedule "BAC" under fasted conditions. Receives: Drug: Treatment A: abiraterone acetate; Drug: Treatment B: abiraterone acetate; Drug: Treatment C: abiraterone acetate |
| Sequence 3: abiraterone acetate | Experimental | Randomly assigned participants in Sequence 3 will receive different dose levels of abiraterone acetate (Treatment A = 250 mg; Treatment B = 500 mg; and Treatment C = 1000 mg) on Day 1 in each of the 3 treatment periods according to the randomized schedule "CBA" under fasted conditions. Receives: Drug: Treatment A: abiraterone acetate; Drug: Treatment B: abiraterone acetate; Drug: Treatment C: abiraterone acetate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum observed plasma concentration of abiraterone
Measured: Pre-dose and up to 96 hours post-dose each treatment period
Time to reach the maximum observed plasma concentration of abiraterone
Measured: Pre-dose and up to 96 hours post-dose each treatment period
Area under the plasma concentration-time curve from time 0 to the last quantifiable concentration of abiraterone
Measured: Pre-dose and up to 96 hours post-dose each treatment period
Area under the plasma concentration-time curve extrapolated to infinite time of abiraterone
Measured: Pre-dose and up to 96 hours post-dose each treatment period
Apparent terminal elimination rate constant of abiraterone
Measured: Pre-dose and up to 96 hours post-dose each treatment period
Apparent terminal elimination half-life of abiraterone
Measured: Pre-dose and up to 96 hours post-dose each treatment period
Secondary outcomes (1)
Number of participants with adverse events
Measured: Up to 42 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2012 (estimated)
- Study startJul 2012
- Primary completionSep 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- 15 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
- NCT01678573
- Sponsor's protocol ID
- CR100668
- Other IDs
- ABI-PRO-1016
- Status last verified
- Sep 2013
- First submitted
- 31 Aug 2012
- Last updated
- 6 Sep 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Dose, Randomized, Open-Label, Three-Way Crossover Study to Evaluate the Pharmacokinetics of Abiraterone in Chinese Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT01678573
- Acronym / sponsor ID
- CR100668
- Conditions
- Healthy
- Keywords
- Healthy, Pharmacokinetics, Abiraterone acetate, Abiraterone, JNJ-212082, Zytiga, Chinese, Fasted
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
- Study start
- Jul 2012
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 5 Sep 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 (how the drug concentrations change over time) of abiraterone acetate after oral administration of abiraterone acetate at different dose levels of 250, 500, and 1000 mg in healthy Chinese male participants under fasted conditions.
Detailed description
This is an open-label (all people know the identity of the intervention), randomized (the treatment sequence is assigned by chance), 3-way crossover study (method used to switch participants from one dose level to another in a clinical study) of single doses of abiraterone acetate in healthy Chinese male participants. The study consists of 3 phases: screening, open-label treatment, and follow up phases. After screening, randomly assigned participants will receive different dose levels of abiraterone acetate (Treatment A = 250 mg; Treatment B = 500 mg; and Treatment C = 1000 mg) on Day 1 in each of the 3 treatment periods according to a randomized schedule under fasted conditions (Sequence 1 = ABC; Sequence 2 = BAC; and Sequence 3 = CBA). Each treatment period will be separated by a washout period (period when participant is not receiving any study medication) of at least 7 days. In the follow-up phase, study-related adverse events will be monitored by the investigator. Serial blood samples for pharmacokinetic analysis will be collected and safety will be monitored throughout the study. The total study duration will be approximately 42 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Sequence 1: abiraterone acetate | Experimental | Drug: Treatment A: abiraterone acetate, Drug: Treatment B: abiraterone acetate, Drug: Treatment C: abiraterone acetateRandomly assigned participants in Sequence 1 will receive different dose levels of abiraterone acetate (Treatment A = 250 mg; Treatment B = 500 mg; and Treatment C = 1000 mg) on Day 1 in each of the 3 treatment periods according to the randomized schedule "ABC" under fasted conditions. |
| Sequence 2: abiraterone acetate | Experimental | Drug: Treatment A: abiraterone acetate, Drug: Treatment B: abiraterone acetate, Drug: Treatment C: abiraterone acetateRandomly assigned participants in Sequence 2 will receive different dose levels of abiraterone acetate (Treatment A = 250 mg; Treatment B = 500 mg; and Treatment C = 1000 mg) on Day 1 in each of the 3 treatment periods according to the randomized schedule "BAC" under fasted conditions. |
| Sequence 3: abiraterone acetate | Experimental | Drug: Treatment A: abiraterone acetate, Drug: Treatment B: abiraterone acetate, Drug: Treatment C: abiraterone acetateRandomly assigned participants in Sequence 3 will receive different dose levels of abiraterone acetate (Treatment A = 250 mg; Treatment B = 500 mg; and Treatment C = 1000 mg) on Day 1 in each of the 3 treatment periods according to the randomized schedule "CBA" under fasted conditions. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Body mass index within 18 to 27 kg/m2 (inclusive) and body weight above 50 kg at screening
- Protocol-defined laboratory and electrocardiogram parameters
- Negative test results for selected medications and substances of abuse and negative exhaled carbon monoxide test at check-in day of each period
- Agrees to protocol-defined use of effective contraception
- Willing to be confined at the clinical research facility for time period specified in the protocol
Key exclusion criteria (7 listed)
- Significant history or current manifestation of any significant metabolic, allergic, dermatological, hepatic, renal, hematologic, pulmonary, cardiovascular, gastrointestinal, neurological, or psychiatric disorder
- History of hypersensitivity reaction to the study medication or related compounds or excipients used in the formulation
- Confirmed hepatitis A, B, or C infection or human immunodeficiency virus (HIV) 1 or HIV-2 infection at screening
- Serum testosterone level of <200 ng/dL
- Use of any tobacco or nicotine-containing products
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 |
|---|---|---|
| Treatment A: abiraterone acetateAlso: ZYTIGA250 mg/day tablet administered orally on Day 1 of each treatment period. | Drug | Sequence 1: abiraterone acetate, Sequence 2: abiraterone acetate, Sequence 3: abiraterone acetate |
| Treatment B: abiraterone acetateAlso: ZYTIGA500 mg/day tablets administered orally on Day 1 of each treatment period. | Drug | Sequence 1: abiraterone acetate, Sequence 2: abiraterone acetate, Sequence 3: abiraterone acetate |
| Treatment C: abiraterone acetateAlso: ZYTIGA1000 mg/day tablets administered orally on Day 1 of each treatment period. | Drug | Sequence 1: abiraterone acetate, Sequence 2: abiraterone acetate, Sequence 3: abiraterone acetate |
Primary outcome
Maximum observed plasma concentration of abiraterone
Time frame: Pre-dose and up to 96 hours post-dose each treatment period
Time to reach the maximum observed plasma concentration of abiraterone
Time frame: Pre-dose and up to 96 hours post-dose each treatment period
Area under the plasma concentration-time curve from time 0 to the last quantifiable concentration of abiraterone
Time frame: Pre-dose and up to 96 hours post-dose each treatment period
Area under the plasma concentration-time curve extrapolated to infinite time of abiraterone
Time frame: Pre-dose and up to 96 hours post-dose each treatment period
Apparent terminal elimination rate constant of abiraterone
Time frame: Pre-dose and up to 96 hours post-dose each treatment period
Apparent terminal elimination half-life of abiraterone
Time frame: Pre-dose and up to 96 hours post-dose each treatment period
1 secondary outcome
Number of participants with adverse events
Time frame: Up to 42 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 6 Sep 2013.
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
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
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 Treatment A: abiraterone acetate, Treatment B: abiraterone acetate and Treatment C: abiraterone acetate in people with Healthy, run by Janssen Research & Development, LLC at 1 site in China.
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 7 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 6 Sep 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 China. 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 abiraterone (time frame: Pre-dose and up to 96 hours post-dose each treatment period). The study lists 6 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 6 Sep 2013.