Last updated on August 2016

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


Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Hepatic Insufficiency | Pharmacokinetics | Renal Failure | Lymphoma | Non-Hodgkin's (NHL) | Pharmacokinetic aspects
  • Age: Between 45 - 79 Years
  • Gender: Male
  • Other:
    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 be eligible for this study if the following are true:

  • 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.

Recruitment Status: Open


Brief Description Eligibility Contact Research Team


Volunteer Sign-up

Sign up for our FREE service to receive email notifications when clinical trials are posted in the medical category of interest to you.