check_circleStudy 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
  • - 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).
  • - 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
September 2016 - December 2017
Phase
Phase 1
Could I Receive a placebo
No
Products
Nubeqa (Darolutamide, BAY1841788)
Accepts Healthy Volunteer
Yes

Where to participate

StatusInstitutionLocation
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
    date_rangeTime Frame:
    Pre-dose up to 48 h post dose
    enhanced_encryption
    Safety Issue:
    No
  • Maximum drug concentration (Cmax) of darolutamide in plasma
    date_rangeTime Frame:
    Pre-dose up to 48 h post dose
    enhanced_encryption
    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
    date_rangeTime Frame:
    Pre-dose up to 48 h post dose
    enhanced_encryption
    Safety Issue:
    No
  • Maximum drug concentration (Cmax) of darolutamide's diastereomer ((S,R)-darolutamide) in plasma
    date_rangeTime Frame:
    Pre-dose up to 48 h post dose
    enhanced_encryption
    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
    date_rangeTime Frame:
    Pre-dose up to 48 h post dose
    enhanced_encryption
    Safety Issue:
    No
  • Maximum drug concentration (Cmax) of darolutamide's diastereomer ((S,S)-darolutamide) in plasma
    date_rangeTime Frame:
    Pre-dose up to 48 h post dose
    enhanced_encryption
    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
    date_rangeTime Frame:
    Pre-dose up to 48 h post dose
    enhanced_encryption
    Safety Issue:
    No
  • Maximum drug concentration (Cmax) of darolutamide's major metabolite (keto-darolutamide) in plasma
    date_rangeTime Frame:
    Pre-dose up to 48 h post dose
    enhanced_encryption
    Safety Issue:
    No
  • Number of subjects with study drug-related treatment-emergent adverse events (TEAEs)
    date_rangeTime Frame:
    From first application of study medication up to 30 days after end of treatment with study medication.
    enhanced_encryption
    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
3

Additional Information

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