Trial Condition(s):
Castration-Resistant Prostate Cancer
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 (ARIADME)
Bayer Identifier:
17831
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
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.
Inclusion Criteria
- 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)Exclusion Criteria
- 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
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Quotient Clinical Nottingham, United Kingdom, NG11 6JS | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
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
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 darolutamideTimeframe: 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-darolutamideTimeframe: 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-darolutamideTimeframe: 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 solutionTimeframe: Pre-dose, Up to 336 hours post-dose
Additional Information
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