check_circleStudy Completed

Castration-resistant prostate cancer

Bayer Identifier:

17831

ClinicalTrials.gov Identifier:

NCT02418650

EudraCT Number:

2013-002061-19

EU CT Number:

Not Available
Study to learn more about the effect of ODM-201 (Nubeqa, Darolutamide, BAY1841788) on the way how the study drug given once acts in the human body of healthy male participants

Trial purpose

ODM-201 (Nubeqa, Darolutamide, BAY1841788) is androgen receptor inhibitor for the treatment of men with growing prostate cancer with the risk of the cancer to spread into other parts of the human body. The goal of the study is to learn more about the way the body absorbs, distributes and excretes the study dug in healthy male participants.

Key Participants Requirements

Sex

Male

Age

50 - 65 Years
  • - Healthy men aged 50 to 65 years (inclusive) who expressed a desire not to father children in the 6 months following dosing
    - Body mass index (BMI) of >18.5 and <32.0 kg/m2
    - Weight 55 to 100 kg (inclusive)

  • - Patients with any condition that required regular concomitant treatment (including vitamins and herbal products) in the 14 days before investigational medicinal product administration or were likely to need any concomitant treatment during the study

Trial summary

Enrollment Goal
12
Trial Dates
March 2015 - May 2015
Phase
Phase 1
Could I Receive a placebo
No
Products
Nubeqa (Darolutamide, BAY1841788)
Accepts Healthy Volunteer
Yes

Where to participate

StatusInstitutionLocation
Completed
Quotient ClinicalNottingham, NG11 6JS, United Kingdom

Primary Outcome

  • Absolute bioavailability of 300 mg darolutamide in plasma after tablet (Regimen A)
    Absolute bioavailability based on AUC of darolutamide after oral administration of a 300 mg tablet darolutamide
    date_rangeTime Frame:
    Pre-dose, Up to 72 hours post-dose
  • Absolute bioavailability of 300 mg darolutamide in plasma after infusion (Regimen B)
    Absolute bioavailability based on AUC of darolutamide after intravenous infusion of 100 µg 14C-darolutamide
    date_rangeTime Frame:
    Pre-dose, Up to 72 hours post-dose
  • Absolute bioavailability of 300 mg darolutamide in plasma after solution (Regimen C)
    Absolute bioavailability based on AUC of darolutamide after oral administration of solution of 300 mg 14C-darolutamide
    date_rangeTime Frame:
    Pre-dose, Up to 216 hours post-dose
  • Mass balance recovery of 14C-radioactivity (Regimen C)
    Mass balance recovery considering urine and feces after a single oral 300 mg dose of [14C]-darolutamide given as a solution
    date_rangeTime Frame:
    Pre-dose, Up to 336 hours post-dose

Trial design

A Two-Part Open-Label, Single-Centre Mass Balance, Pharmacokinetics, Biotransformation and Absolute Bioavailability Study of ODM-201 in Healthy Male Subjects
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Non-randomized
Blinding
N/A
Assignment
Parallel Assignment
Trial Arms
2

Additional Information

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