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:

NCT02418650

EudraCT Number:

2013-002061-19

Study Completed

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
12
Trial Dates
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Phase
1
Could I receive a placebo?
No
Products
Nubeqa (Darolutamide, BAY1841788)
Accepts Healthy Volunteers
Yes

Where to Participate

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Locations
Status
LocationsStatus
Locations

Quotient Clinical

Nottingham, United Kingdom, NG11 6JS

Status
Completed
 

Trial Design