Prostatic NeoplasmsPhase 1NCT04577833
A Study of Comparative Formulations of Niraparib and Abiraterone Acetate (AA) in Men With Prostate Cancer
A Phase 1 study testing Niraparib, Abiraterone Acetate (AA) and Prednisone in people with Prostatic Neoplasms, run by Janssen Research & Development, LLC at 16 sites in 11 countries.
Trial summary
The purpose of this study is to determine the relative bioavailability (rBA; Period 1) and bioequivalence (BE; Period 2 and 3) of various strengths and formulations of niraparib and abiraterone acetate (AA) at steady state under modified fasted conditions in participants with metastatic castration-resistant prostate… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostatic Neoplasms
- What is being tested?
- Niraparib, Abiraterone Acetate (AA) and Prednisone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 136 participants
- Where
- 16 sitesin 11 countries
- Study dates
- 13 Nov 2020to 31 Dec 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically or cytologically confirmed adenocarcinoma of the prostate
- Diagnosed with metastatic castration-resistant prostate cancer (mCRPC), who in the opinion of the investigator may benefit from treatment in this study
- Able to continue gonadotropin-releasing hormone analogues (GnRHa) therapy during the study if not surgically castrate (that is, participants who have not undergone bilateral orchiectomy)
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) of less than or equal to (<=) 1
- Willing to provide a tumor sample (archival) for determination of homologous recombination repair (HRR) gene alteration status
Who cannot join
- Symptomatic brain metastases
- Prior disease progression during treatment with abiraterone acetate (AA) alone or when combined with a poly adenosine diphosphate (ADP)-ribose polymerase inhibitor (PARPi). Prior discontinuation of treatment with AA or PARPi due to AA- or PARPi related toxicity.
- History or current diagnosis of myelodysplastic syndrome (MDS)/ acute myeloid leukemia (AML)
- Known allergies, hypersensitivity, or intolerance to niraparib or AA or the corresponding excipients of niraparib/AA
- Any medical condition that would make prednisone/prednisolone use contraindicated
Trial locations and contacts
16 sites in 11 countries.
16 sites in 11 countries
Spain3 sites
Hosp Univ Fund Jimenez Diaz
Madrid, 28040
Hosp Univ Hm Sanchinarro
Madrid, 28050
Hosp Virgen de La Victoria
Málaga, 29010
Belgium2 sites
Universitair Ziekenhuis Gent
Ghent, 9000
GZA Ziekenhuizen- Campus St Augustinus
Wilrijk, 2610
France2 sites
Institut Bergonié, Centre de Lutte Contre le Cancer
Bordeaux, 33000
HIA Begin
Saint-Mandé, 94163
Poland2 sites
Uniwersyteckie Centrum Kliniczne
Gdansk, 80 214
Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy
Warsaw, 02-781
United Kingdom1 site
Sir Bobby Robson Unit, Northern Centre for Cancer Care
Newcastle upon Tyne, NE7 7DN
About this study
Official title: An Open-label, Randomized Study to Assess the Relative Bioavailability (BA) and Bioequivalence (BE) of Comparative Formulations of Niraparib and Abiraterone Acetate (AA) in Men With Prostate Cancer
The purpose of this study is to determine the relative bioavailability (rBA; Period 1) and bioequivalence (BE; Period 2 and 3) of various strengths and formulations of niraparib and abiraterone acetate (AA) at steady state under modified fasted conditions in participants with metastatic castration-resistant prostate cancer (mCRPC).
Read the detailed description
Niraparib is an orally available, highly selective poly (adenosine diphosphate [ADP]-ribose) polymerase (PARP) inhibitor, with potent activity against PARP-1 and PARP-2 deoxyribonucleic acid (DNA)-repair polymerases. AA is a pro-drug of abiraterone which selectively inhibits the enzyme 17 alpha-hydroxylase/C17,20-lyase (CYP17), that is found in the testes and adrenals (leading to systemic inhibition of testosterone production), as well as in prostate tissues and tumors. The rationale of the study is to investigate the various strengths and formulations of niraparib and AA plus prednisone or prednisolone (P) in metastatic castration resistant prostate cancer (mCRPC) participants with and without homologous recombination repair (HRR) gene alterations. In participants with metastatic prostate cancer, DNA-repair anomalies are found in approximately 15 percent (%) to 20% of tumors. This study consists 4 periods: screening phase (up to 21 days); treatment phase (up to 22 days); extension and long-term extension phases (from day 23 until discontinuation); and post-treatment follow up phase (end of treatment [EoT] visit within 30 days after the last dose of study treatment). Total duration of study is up to 1.4 years. Efficacy, safety, pharmacokinetics (PK), and biomarkers will be assessed at specified time points during this study. Participants safety will be monitored throughout the study.
- Conditions
- Prostatic Neoplasms
- Being tested
- Niraparib, Abiraterone Acetate (AA), Prednisone
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NiraparibDrug
Niraparib will be administered orally.
Abiraterone Acetate (AA)Drug
Abiraterone Acetate will be administered orally.
PrednisoneDrug
Prednisone will be administered orally.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Sequence ABD | Experimental | Participants will receive single doses of niraparib and abiraterone acetate (AA) using niraparib Formulation 1 as Treatment A in Treatment Period 1, followed by multiple doses of niraparib and AA using niraparib Formulation 2 as Treatment B in Treatment Period 2, followed by multiple doses of niraparib and AA using niraparib Formulation 4 as Treatment D in Treatment Period 3. From Period 2 onwards and during Extension and Long-term Extension Phases, all participants will continue to receive treatment with niraparib and AA-prednisone (AAP) or AAP alone. Receives: Drug: Niraparib; Drug: Abiraterone Acetate (AA); Drug: Prednisone |
| Treatment Sequence ADB | Experimental | Participants will receive Treatment A in Treatment Period 1 followed by Treatment D in Treatment Period 2, followed by Treatment B in Treatment Period 3. From Period 2 onwards and during Extension and Long-term Extension Phases, all participants will continue to receive treatment with niraparib and AAP or AAP alone. Receives: Drug: Niraparib; Drug: Abiraterone Acetate (AA); Drug: Prednisone |
| Treatment Sequence CBD | Experimental | Participants will receive single doses of niraparib and AA using niraparib Formulation 3 as Treatment C in Treatment Period 1, followed by Treatment B in Treatment Period 2, followed by Treatment D in Treatment Period 3. From Period 2 onwards and during Extension and Long-term Extension Phases, all participants will continue to receive treatment with niraparib and AAP or AAP alone. Receives: Drug: Niraparib; Drug: Abiraterone Acetate (AA); Drug: Prednisone |
| Treatment Sequence CDB | Experimental | Participants will receive Treatment C in Treatment Period 1, followed by Treatment D in Treatment Period 2, followed by Treatment B in Treatment Period 3. From Period 2 onwards and during Extension and Long-term Extension Phases, all participants will continue to receive treatment with niraparib and AAP or AAP alone. Receives: Drug: Niraparib; Drug: Abiraterone Acetate (AA); Drug: Prednisone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Observed Analyte Concentration at Steady State (Cmax,ss) of Niraparib and Abiraterone Acetate (AA) [Period 2 and Period 3]
Cmax,ss is defined as maximum observed analyte concentration at steady state.
Measured: Predose, up to 10 hour post dose
Area Under the Plasma Concentration-time Curve from Time Zero to 24 Hours at Steady State (AUC [0-24h],ss) of Niraparib and AA (Period 2 and Period 3)
AUC (0-24h),ss is defined as area under the plasma concentration-time curve from time zero to 24 hours at steady state.
Measured: Predose, up to 24 hours post dose
Ratio of Individual Cmax,ss Values Between Test and Reference Treatment (Period 2 and Period 3)
Ratio of individual Cmax,ss values between test and reference treatment will be assessed.
Measured: Predose, up to 10 hours post dose
Ratio of individual AUC (0-24h),ss Values Between Test and Reference Treatment (Period 2 and Period 3)
Ratio of individual AUC (0-24h),ss values between test and reference treatment will be assessed.
Measured: Predose, up to 24 hours post dose
Secondary outcomes (7)
Maximum Observed Analyte Concentration at (Cmax) of Niraparib and AA (Period 1)
Cmax is defined as maximum observed analyte concentration.
Measured: Predose, up to 72 hours post dose
Area Under the Plasma Concentration-time Curve from Time Zero to 72 Hours (AUC [0-72h]) of Niraparib and AA (Period 1)
AUC (0-72h) is defined as area under the plasma concentration-time curve from time zero to 72 hours post dosing.
Measured: Predose, up to 72 hours post dose
Ratio of individual AUC (0-72h) Values Between Test and Reference Treatment (Period 1)
Ratio of individual AUC (0-72h) values between test and reference treatment will be assessed.
Measured: Predose, up to 72 hours post dose
Serum Testosterone Level
Serum testosterone level will be assessed.
Measured: Predose on Day -7, Day 11, Day 12 and Day 23
Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability
An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.
Measured: From study start until study completion (up to 3.1 years)
Number of Participants with AEs by Severity
Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. Severity scale ranges from Grade 1 (Mild) to Grade 5 (Death). Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Life-threatening and Grade 5= Death.
Measured: From study start until study completion (up to 3.1 years)
Number of Participants with Clinical Laboratory Abnormalities
Number of participants with clinical laboratory abnormalities including hematology, serum chemistry and urinalysis will be reported.
Measured: From study start until study completion (up to 3.1 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2020
- Study start13 Nov 2020
- Primary completion15 Oct 2021
- Study completion31 Dec 2027 (estimated)
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 Prostatic NeoplasmsStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 136 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
- NCT04577833
- Sponsor's protocol ID
- CR108783
- Other IDs
- 67652000PCR1001, 2019-000137-39, 2023-508150-26-00, 2023, 2019
- Status last verified
- Nov 2026
- First submitted
- 5 Oct 2020
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
Publications
Yu A, Hazra A, Jiao JJ, Hellemans P, Mitselos A, Tian H, Ruixo JJP, Haddish-Berhane N, Ouellet D, Russu A. Demonstrating Bioequivalence for Two Dose Strengths of Niraparib and Abiraterone Acetate Dual-Action Tablets Versus Single Agents: Utility of Clinical Study Data Supplemented with Modeling and Simulation. Clin Pharmacokinet. 2024 Apr;63(4):511-527. doi: 10.1007/s40262-023-01340-5. Epub 2024 Mar 4.
PubMed 38436924
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Randomized Study to Assess the Relative Bioavailability (BA) and Bioequivalence (BE) of Comparative Formulations of Niraparib and Abiraterone Acetate (AA) in Men With Prostate Cancer
- ClinicalTrials.gov ID
- NCT04577833
- Acronym / sponsor ID
- CR108783
- Conditions
- Prostatic Neoplasms
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 136 participants (actual)
- Lead sponsor
- Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
- Study start
- 13 Nov 2020 (actual)
- Primary completion
- 15 Oct 2021 (actual)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 8 Oct 2020 (actual)
- 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 determine the relative bioavailability (rBA; Period 1) and bioequivalence (BE; Period 2 and 3) of various strengths and formulations of niraparib and abiraterone acetate (AA) at steady state under modified fasted conditions in participants with metastatic castration-resistant prostate cancer (mCRPC).
Detailed description
Niraparib is an orally available, highly selective poly (adenosine diphosphate [ADP]-ribose) polymerase (PARP) inhibitor, with potent activity against PARP-1 and PARP-2 deoxyribonucleic acid (DNA)-repair polymerases. AA is a pro-drug of abiraterone which selectively inhibits the enzyme 17 alpha-hydroxylase/C17,20-lyase (CYP17), that is found in the testes and adrenals (leading to systemic inhibition of testosterone production), as well as in prostate tissues and tumors. The rationale of the study is to investigate the various strengths and formulations of niraparib and AA plus prednisone or prednisolone (P) in metastatic castration resistant prostate cancer (mCRPC) participants with and without homologous recombination repair (HRR) gene alterations. In participants with metastatic prostate cancer, DNA-repair anomalies are found in approximately 15 percent (%) to 20% of tumors. This study consists 4 periods: screening phase (up to 21 days); treatment phase (up to 22 days); extension and long-term extension phases (from day 23 until discontinuation); and post-treatment follow up phase (end of treatment [EoT] visit within 30 days after the last dose of study treatment). Total duration of study is up to 1.4 years. Efficacy, safety, pharmacokinetics (PK), and biomarkers will be assessed at specified time points during this study. Participants safety will be monitored throughout the study.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Treatment Sequence ABD | Experimental | Drug: Niraparib, Drug: Abiraterone Acetate (AA), Drug: PrednisoneParticipants will receive single doses of niraparib and abiraterone acetate (AA) using niraparib Formulation 1 as Treatment A in Treatment Period 1, followed by multiple doses of niraparib and AA using niraparib Formulation 2 as Treatment B in Treatment Period 2, followed by multiple doses of niraparib and AA using niraparib Formulation 4 as Treatment D in Treatment Period 3. From Period 2 onwards and during Extension and Long-term Extension Phases, all participants will continue to receive treatment with niraparib and AA-prednisone (AAP) or AAP alone. |
| Treatment Sequence ADB | Experimental | Drug: Niraparib, Drug: Abiraterone Acetate (AA), Drug: PrednisoneParticipants will receive Treatment A in Treatment Period 1 followed by Treatment D in Treatment Period 2, followed by Treatment B in Treatment Period 3. From Period 2 onwards and during Extension and Long-term Extension Phases, all participants will continue to receive treatment with niraparib and AAP or AAP alone. |
| Treatment Sequence CBD | Experimental | Drug: Niraparib, Drug: Abiraterone Acetate (AA), Drug: PrednisoneParticipants will receive single doses of niraparib and AA using niraparib Formulation 3 as Treatment C in Treatment Period 1, followed by Treatment B in Treatment Period 2, followed by Treatment D in Treatment Period 3. From Period 2 onwards and during Extension and Long-term Extension Phases, all participants will continue to receive treatment with niraparib and AAP or AAP alone. |
| Treatment Sequence CDB | Experimental | Drug: Niraparib, Drug: Abiraterone Acetate (AA), Drug: PrednisoneParticipants will receive Treatment C in Treatment Period 1, followed by Treatment D in Treatment Period 2, followed by Treatment B in Treatment Period 3. From Period 2 onwards and during Extension and Long-term Extension Phases, all participants will continue to receive treatment with niraparib and AAP or AAP alone. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Histologically or cytologically confirmed adenocarcinoma of the prostate
- Diagnosed with metastatic castration-resistant prostate cancer (mCRPC), who in the opinion of the investigator may benefit from treatment in this study
- Able to continue gonadotropin-releasing hormone analogues (GnRHa) therapy during the study if not surgically castrate (that is, participants who have not undergone bilateral orchiectomy)
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) of less than or equal to (<=) 1
- Willing to provide a tumor sample (archival) for determination of homologous recombination repair (HRR) gene alteration status
Key exclusion criteria (5 listed)
- Symptomatic brain metastases
- Prior disease progression during treatment with abiraterone acetate (AA) alone or when combined with a poly adenosine diphosphate (ADP)-ribose polymerase inhibitor (PARPi). Prior discontinuation of treatment with AA or PARPi due to AA- or PARPi related toxicity.
- History or current diagnosis of myelodysplastic syndrome (MDS)/ acute myeloid leukemia (AML)
- Known allergies, hypersensitivity, or intolerance to niraparib or AA or the corresponding excipients of niraparib/AA
- Any medical condition that would make prednisone/prednisolone use contraindicated
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 |
|---|---|---|
| NiraparibNiraparib will be administered orally. | Drug | Treatment Sequence ABD, Treatment Sequence ADB, Treatment Sequence CBD, Treatment Sequence CDB |
| Abiraterone Acetate (AA)Abiraterone Acetate will be administered orally. | Drug | Treatment Sequence ABD, Treatment Sequence ADB, Treatment Sequence CBD, Treatment Sequence CDB |
| PrednisonePrednisone will be administered orally. | Drug | Treatment Sequence ABD, Treatment Sequence ADB, Treatment Sequence CBD, Treatment Sequence CDB |
Primary outcome
Maximum Observed Analyte Concentration at Steady State (Cmax,ss) of Niraparib and Abiraterone Acetate (AA) [Period 2 and Period 3]
Time frame: Predose, up to 10 hour post dose
Cmax,ss is defined as maximum observed analyte concentration at steady state.
Area Under the Plasma Concentration-time Curve from Time Zero to 24 Hours at Steady State (AUC [0-24h],ss) of Niraparib and AA (Period 2 and Period 3)
Time frame: Predose, up to 24 hours post dose
AUC (0-24h),ss is defined as area under the plasma concentration-time curve from time zero to 24 hours at steady state.
Ratio of Individual Cmax,ss Values Between Test and Reference Treatment (Period 2 and Period 3)
Time frame: Predose, up to 10 hours post dose
Ratio of individual Cmax,ss values between test and reference treatment will be assessed.
Ratio of individual AUC (0-24h),ss Values Between Test and Reference Treatment (Period 2 and Period 3)
Time frame: Predose, up to 24 hours post dose
Ratio of individual AUC (0-24h),ss values between test and reference treatment will be assessed.
7 secondary outcomes
Maximum Observed Analyte Concentration at (Cmax) of Niraparib and AA (Period 1)
Time frame: Predose, up to 72 hours post dose
Area Under the Plasma Concentration-time Curve from Time Zero to 72 Hours (AUC [0-72h]) of Niraparib and AA (Period 1)
Time frame: Predose, up to 72 hours post dose
Ratio of individual AUC (0-72h) Values Between Test and Reference Treatment (Period 1)
Time frame: Predose, up to 72 hours post dose
Serum Testosterone Level
Time frame: Predose on Day -7, Day 11, Day 12 and Day 23
Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability
Time frame: From study start until study completion (up to 3.1 years)
Number of Participants with AEs by Severity
Time frame: From study start until study completion (up to 3.1 years)
Number of Participants with Clinical Laboratory Abnormalities
Time frame: From study start until study completion (up to 3.1 years)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
- Derived from this study: PubMed 38436924Yu A, Hazra A, Jiao JJ, Hellemans P, Mitselos A, Tian H, Ruixo JJP, Haddish-Berhane N, Ouellet D, Russu A. Demonstrating Bioequivalence for Two Dose Strengths of Niraparib and Abiraterone Acetate Dual-Action Tablets Versus Single Agents: Utility of Clinical Study Data Supplemented with Modeling and Simulation. Clin Pharmacokinet. 2024 Apr;63(4):511-527. doi: 10.1007/s40262-023-01340-5. Epub 2024 Mar 4.
- Individual participant dataSharing planned: Yes. The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
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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
16 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Niraparib, Abiraterone Acetate (AA) and Prednisone in people with Prostatic Neoplasms, run by Janssen Research & Development, LLC at 16 sites in 11 countries.
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: under way, not looking for participants, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in Spain, Belgium, France, Poland, United States and 6 more countries. 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?
This study is still under way. Results are not available in the source record yet.
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 Analyte Concentration at Steady State (Cmax,ss) of Niraparib and Abiraterone Acetate (AA) [Period 2 and Period 3] (time frame: Predose, up to 10 hour post dose). The study lists 4 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 NCT04577833, 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 3 Nov 2026.