check_circleStudy Completed

Castration-resistant prostate cancer

Study to investigate the availability of the study drug ODM-201 in the body of patients with prostate cancer, as affected by food and drug formulations

Trial purpose

The purpose of the study is to test how well patients with prostate cancer that keeps growing and has spread to other parts of the body respond to treatment with ODM-201 (Nubeqa, Darolutamide, BAY1841788). The alteration of the study drug as affected by food and drug formulation is also investigated. The study medication ODM-201 is an androgen receptor inhibitor tested in men with metastatic castration-resistant prostate cancer (mCRPC).

Key Participants Requirements

Sex

Male

Age

18 - N/A

Trial summary

Enrollment Goal
30
Trial Dates
March 2013 - December 2020
Phase
Phase 1
Could I Receive a placebo
No
Products
Nubeqa (Darolutamide, BAY1841788)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Helsinki University Central HospitalHelsinki, 00029, Finland
Completed
Tampere University HospitalTampere, 33521, Finland
Completed
Institut Gustave RoussyVillejuif, 94805, France
Completed
Curie InstituteParis, 75248, France
Completed
CHD La Roche Sur YonLa Roche sur Yon, 85925, France
Completed
Center Eugene MarquisRennes, 35042, France
Completed
P. Stradins Clinical University HospitalRiga, 1002, Latvia
Completed
Vidzemes HospitalValmiera, 4201, Latvia
Completed
Riga East University HospitalRiga, 1038, Latvia

Primary Outcome

  • Peak concentration of darolutamide in plasma (Cmax)
    date_rangeTime Frame:
    9 days
  • Area under the darolutamide concentration-time curve from time 0 to time 48 hours (AUC48)
    date_rangeTime Frame:
    9 days
  • Area under the darolutamide concentration-time curve from time 0 to infinity (AUC∞)
    date_rangeTime Frame:
    9 days
  • Relative bioavailability
    date_rangeTime Frame:
    35 days
  • Number of participants with adverse events in PK component
    date_rangeTime Frame:
    35 days
  • Number of participants with adverse events in extension component
    date_rangeTime Frame:
    Up to 4 years

Trial design

A bioavailability study of ODM-201 formulations with a safety and tolerability extension component in subjects with metastatic chemotherapy-naïve castration-resistant prostate cancer
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Randomized
Blinding
N/A
Assignment
Crossover Assignment
Trial Arms
3