Study Completed

Pharmacokinetics, Hepatic Insufficiency, Renal Insufficiency

Bayer Identifier:

17721

ClinicalTrials.gov Identifier:

NCT02894385

EudraCT Number:

2016-001069-10

EU CT Number:

Not Available

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

Trial purpose

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

Key Participants Requirements

Sex

Male

Age

45 - 79 Years

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

Trial Dates

September 2016 - December 2017

Phase

Phase 1

Could I Receive a placebo

Products

Nubeqa (Darolutamide, BAY1841788)

Accepts Healthy Volunteer

Yes

Where to participate

Status	Institution	Location
Completed		Kiel, 24105, Germany
Completed		Lübeck, 23538, Germany

Primary Outcome

Area under the concentration-time curve of darolutamide from time zero to 48 hours (AUC(0-48)) in plasma
Time Frame:
Pre-dose up to 48 h post dose
Safety Issue:
No
Maximum drug concentration (Cmax) of darolutamide in plasma
Time Frame:
Pre-dose up to 48 h post dose
Safety Issue:
No

Secondary Outcome

Area under the concentration-time curve of darolutamide’s diastereomer ((S,R)-darolutamide) from time zero to 48 hours (AUC(0-48)) in plasma
Time Frame:
Pre-dose up to 48 h post dose
Safety Issue:
No
Maximum drug concentration (Cmax) of darolutamide's diastereomer ((S,R)-darolutamide) in plasma
Time Frame:
Pre-dose up to 48 h post dose
Safety Issue:
No
Area under the concentration-time curve of darolutamide’s diastereomer ((S,S)-darolutamide) from time zero to 48 hours (AUC(0-48)) in plasma
Time Frame:
Pre-dose up to 48 h post dose
Safety Issue:
No
Maximum drug concentration (Cmax) of darolutamide's diastereomer ((S,S)-darolutamide) in plasma
Time Frame:
Pre-dose up to 48 h post dose
Safety Issue:
No
Area under the concentration-time curve of darolutamide’s major metabolite (keto-darolutamide) from time zero to 48 hours (AUC(0-48)) in plasma
Time Frame:
Pre-dose up to 48 h post dose
Safety Issue:
No
Maximum drug concentration (Cmax) of darolutamide's major metabolite (keto-darolutamide) in plasma
Time Frame:
Pre-dose up to 48 h post dose
Safety Issue:
No
Number of subjects with study drug-related treatment-emergent adverse events (TEAEs)
Time Frame:
From first application of study medication up to 30 days after end of treatment with study medication.
Safety Issue:
Yes

Trial design

A Phase I, non-randomized, open-label, single-dose study to investigate the pharmacokinetics, safety and tolerability of BAY 1841788 (ODM-201) in male subjects with hepatic impairment, renal impairment and normal hepatic and renal function

Trial Type

Interventional

Intervention Type

Drug

Trial Purpose

Other

Allocation

Non-randomized

Blinding

Open Label

Assignment

Parallel Assignment

Trial Arms

Additional Information

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