A Study of Comparative Formulations of Niraparib and Abiraterone Acetate (AA) in Men With Prostate Cancer

Part of paid clinical trials in West Valley City, Utah.

Sponsor
Janssen Research & Development, LLC
Study ID
NCT04577833
Phase
PHASE1
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Niraparib — DRUG
    Niraparib will be administered orally.
  • Abiraterone Acetate (AA) — DRUG
    Abiraterone Acetate will be administered orally.
  • Prednisone — DRUG
    Prednisone will be administered orally.

Study Details

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).

Key Dates

Start date
Nov 13, 2020
Status verified
Jun 2026
Primary completion
Oct 15, 2021
Completion
Dec 31, 2026

Study Design

Enrollment
136 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER

Arms

  • Experimental: Treatment Sequence ABD
    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.
  • Experimental: Treatment Sequence ADB
    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.
  • Experimental: Treatment Sequence CBD
    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.
  • Experimental: Treatment Sequence CDB
    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.

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 ]

Locations (1)

FacilityCityStateZIPSite coordinators
START Mountain RegionWest Valley CityUtah84119-

Find similar trials in West Valley City, UT

By condition
Prostate cancer
By specialty
OncologyProstate oncologyMen's healthUrology
By research site
START Mountain Region· West Valley City, UT

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