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

Pharmacokinetics Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02894385
• Other study ID #: 17721
• Secondary ID: 2016-001069-10
• Status: Completed
• Phase: Phase 1
• Start date: September 13, 2016
• Est. completion date: December 15, 2017

Study information

• Verified date: January 2019
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: December 15, 2017
• Est. primary completion date: April 10, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 45 Years to 79 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hepatic Insufficiency
• Liver Failure
• Pharmacokinetics
• Renal Insufficiency

Intervention

Drug:
• BAY1841788
600 mg single dose, administered as 2 x 300 mg tablets on Day 00.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Bayer	Orion Corporation, Orion Pharma

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Maximum drug concentration (Cmax) of darolutamide in plasma		Pre-dose up to 48 h post dose
Secondary	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
Secondary	Maximum drug concentration (Cmax) of darolutamide's diastereomer ((S,R)-darolutamide) in plasma		Pre-dose up to 48 h post dose
Secondary	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
Secondary	Maximum drug concentration (Cmax) of darolutamide's diastereomer ((S,S)-darolutamide) in plasma		Pre-dose up to 48 h post dose
Secondary	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
Secondary	Maximum drug concentration (Cmax) of darolutamide's major metabolite (keto-darolutamide) in plasma		Pre-dose up to 48 h post dose
Secondary	Number of subjects with study drug-related treatment-emergent adverse events (TEAEs)		From first application of study medication up to 30 days after end of treatment with study medication.

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