Effect of Hepatic and Renal Impairment on the Pharmacokinetics, Safety and Tolerability of BAY1841788 (ODM-201)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

29 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-13

Study Completion Date

2017-12-15

Brief Summary

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

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Detailed Description

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The study was closed after Part 1 because additional investigation in volunteers with moderate renal impairment in Part 2 was not deemed to be ethically or scientifically justified.

Conditions

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Pharmacokinetics Hepatic Insufficiency Renal Insufficiency

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Part 1 - Subjects with severe renal impairment

Subjects with severe renal impairment received a single oral dose of darolutamide 600 mg (2 x 300 mg tablets).

Group Type EXPERIMENTAL

BAY1841788

Intervention Type DRUG

600 mg single dose, administered as 2 x 300 mg tablets on Day 00.

Part 1 - Subjects with moderate hepatic impairment

Subjects with moderate hepatic impairment received a single oral dose of darolutamide 600 mg (2 x 300 mg tablets).

Group Type EXPERIMENTAL

BAY1841788

Intervention Type DRUG

600 mg single dose, administered as 2 x 300 mg tablets on Day 00.

Part 1 - Healthy subjects

Healthy subjects received a single oral dose of darolutamide 600 mg (2 x 300 mg tablets).

Group Type EXPERIMENTAL

BAY1841788

Intervention Type DRUG

600 mg single dose, administered as 2 x 300 mg tablets on Day 00.

Interventions

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BAY1841788

600 mg single dose, administered as 2 x 300 mg tablets on Day 00.

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

45 Years

Maximum Eligible Age

79 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes