NCT02894385

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
29

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Sep 2016

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 29, 2016

Completed
11 days until next milestone

First Posted

Study publicly available on registry

September 9, 2016

Completed
4 days until next milestone

Study Start

First participant enrolled

September 13, 2016

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 10, 2017

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2017

Completed
Last Updated

January 7, 2019

Status Verified

January 1, 2019

Enrollment Period

7 months

First QC Date

August 29, 2016

Last Update Submit

January 4, 2019

Conditions

PharmacokineticsHepatic InsufficiencyRenal Insufficiency

Outcome Measures

Primary Outcomes (2)

  • Area under the concentration-time curve of darolutamide from time zero to 48 hours (AUC(0-48)) in plasma

    Pre-dose up to 48 h post dose

  • Maximum drug concentration (Cmax) of darolutamide in plasma

    Pre-dose up to 48 h post dose

Secondary Outcomes (7)

  • Area under the concentration-time curve of darolutamide's diastereomer ((S,R)-darolutamide) from time zero to 48 hours (AUC(0-48)) in plasma

    Pre-dose up to 48 h post dose

  • Maximum drug concentration (Cmax) of darolutamide's diastereomer ((S,R)-darolutamide) in plasma

    Pre-dose up to 48 h post dose

  • Area under the concentration-time curve of darolutamide's diastereomer ((S,S)-darolutamide) from time zero to 48 hours (AUC(0-48)) in plasma

    Pre-dose up to 48 h post dose

  • Maximum drug concentration (Cmax) of darolutamide's diastereomer ((S,S)-darolutamide) in plasma

    Pre-dose up to 48 h post dose

  • Area under the concentration-time curve of darolutamide's major metabolite (keto-darolutamide) from time zero to 48 hours (AUC(0-48)) in plasma

    Pre-dose up to 48 h post dose

  • +2 more secondary outcomes

Study Arms (3)

Part 1 - Subjects with severe renal impairment

EXPERIMENTAL

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

Drug: BAY1841788

Part 1 - Subjects with moderate hepatic impairment

EXPERIMENTAL

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

Drug: BAY1841788

Part 1 - Healthy subjects

EXPERIMENTAL

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

Drug: BAY1841788

Interventions

BAY1841788DRUG

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

Part 1 - Healthy subjectsPart 1 - Subjects with moderate hepatic impairmentPart 1 - Subjects with severe renal impairment

Eligibility Criteria

Age45 Years - 79 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Unknown Facility

Kiel, Schleswig-Holstein, 24105, Germany

Location

Unknown Facility

Lübeck, 23538, Germany

Location

Related Publications (1)

  • Zurth C, Nykanen P, Wilkinson G, Taavitsainen P, Vuorela A, Huang F, Reschke S, Koskinen M. Clinical Pharmacokinetics of the Androgen Receptor Inhibitor Darolutamide in Healthy Subjects and Patients with Hepatic or Renal Impairment. Clin Pharmacokinet. 2022 Apr;61(4):565-575. doi: 10.1007/s40262-021-01078-y. Epub 2021 Dec 6.

    PMID: 34866168DERIVED

Related Links

MeSH Terms

Conditions

Hepatic InsufficiencyRenal Insufficiency

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 29, 2016

First Posted

September 9, 2016

Study Start

September 13, 2016

Primary Completion

April 10, 2017

Study Completion

December 15, 2017

Last Updated

January 7, 2019

Record last verified: 2019-01

Locations

DE(2)