Trial Condition(s):

Pharmacokinetics, Hepatic Insufficiency, Renal Insufficiency

Effect of hepatic and renal impairment on the pharmacokinetics, safety and tolerability of BAY1841788 (ODM-201)

Bayer Identifier:

17721

ClinicalTrials.gov Identifier:

NCT02894385

EudraCT Number:

2016-001069-10

Study Completed

Trial Purpose

Evaluate the potential effect of hepatic or renal impairment on the pharmacokinetics, safety and tolerability of BAY 1841788 (ODM-201).

Inclusion Criteria
- All subjects
-- Male and white subjects between 45 and 79 years of age with a body mass index between 18 to 34 kg/m*2 (both inclusive).
- Patients with moderate hepatic impairment (Part 1)
-- Patients with documented liver cirrhosis confirmed by histopathology, e.g., previous liver biopsy, laparoscopy, ultrasound, or fibroscan and with moderate hepatic impairment (defined as Child Pugh class B).
- Patients with severe renal impairment (Part 1)
-- Patients with severe renal impairment with an estimated glomerular filtration rate 15-29 mL/min/1.73 m*2, who are not on dialysis and are not expected to start dialysis in the next 3 months (Stage 4).
- Healthy subjects
-- Healthy as determined by the investigator or medically qualified designee based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring and with estimated glomerular filtration rate >90 mL/min (according to Modified Diet of Renal Disease equation).
- Patients with moderate renal impairment (Part 2)
-- Patients with moderate renal impairment with an estimated glomerular filtration rate 30-59 mL/min/1.73 m*2 (Stage 3).
- Patients with mild renal impairment (Part 2)
-- Patients with mild renal impairment with an estimated glomerular filtration rate (eGFR) 60-79 mL/min/1.73 m*2 (Stage 2).
- Patients with mild hepatic impairment (Part 2)
-- Patients with documented liver cirrhosis confirmed by histopathology, e.g., previous liver biopsy, laparoscopy, ultrasound, or fibroscan.
-- Patients with mild hepatic impairment (defined as Child Pugh class A).
Exclusion Criteria
- Severe cerebrovascular or cardiac disorders, e.g., myocardial infarction less than 6 months prior to dosing, congestive heart failure of New York Heart Association (NYHA) grade III or IV. 
- Subjects with percutaneous transluminal coronary angioplasty or coronary artery bypass graft less than 6 months prior to study drug administration. 
- Strong cytochrome P450 (CYP) 3A4 inhibitors or strong CYP3A4 inducers within 28 days or 5 drug half-lives (if drug half-life in patients is known), before start of study treatment. 
- Known BCRP (breast cancer resistant protein) and OATP (organic anion-transporting polypeptide) substrates not specifically mentioned in the protocol within 28 days or 5 drug half-lives (if drug half-life in patients is known), before start of study treatment.
- Smoking more than 20 cigarettes daily.

Trial Summary

Enrollment Goal
29
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

Investigative Site

Kiel, Germany, 24105

Status
Completed
 
Locations

Investigative Site

Lübeck, Germany, 23538

Status
Completed
 

Trial Design