Nintedanib in Volunteers With Hepatic Impairment Compared With Healthy Volunteers
Condition: Hepatic Insufficiency
MeSH terms: Hepatic Insufficiency; Liver Failure
Intervention: Nintedanib; Nintedanib; Nintedanib
Intervention description: Soft gelatine capsule; Soft gelatine capsule; Soft gelatine capsule
Intervention MeSH terms: Nintedanib
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 33.0
Sex: All
Minimum age: 18 Years
Maximum age: 79 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The primary objective of this study is to investigate the effect of mild (Child-Pugh A, score
      5-6) and moderate (Child-Pugh B, score 7-9) hepatic impairment on the pharmacokinetics,
      safety and tolerability of nintedanib, in comparison with a control group with normal hepatic
      function following oral administration of nintedanib as single dose.
    

Eligibility criteria:

        Inclusion criteria:

        Healthy subjects:

          -  Male or female subject, healthy according to the investigator's judgement based on a
             complete medical history, including a physical examination, vital signs (BP, PR),
             12-lead ECG, and clinical laboratory

          -  Age of 18 to 79 years at screening visit

        Hepatically impaired patients as determined by a hepatologist/ gastroenterologist:

          -  A documented diagnosis of the impaired hepatic function, determined by
             hepatologist/gastroenterologist/specialist for internal medicine, must be available in
             the patient´s source data.

          -  Male or female chronic hepatically impaired patient as determined by screening results
             and classified as Child-Pugh A (Child-Pugh score of 5-6 points) or as Child-Pugh B
             (Child-Pugh score of 7-9 points). Hepatic insufficiency must be diagnosed at least 3
             months before screening.

          -  Age of 18 to 79 years at screening visit

        Exclusion criteria:

        Healthy subjects:

          -  Any finding in the medical examination (including BP, PR or ECG) deviating from normal
             and judged as clinically relevant by the investigator

          -  Any laboratory value outside the reference range at screening visit that the
             investigator considers to be of clinical relevance

          -  Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic,
             immunological or hormonal disorders judged as clinically relevant by the investigator

          -  Surgery of the gastrointestinal tract that could interfere with kinetics of the trial
             medication based on the investigator´s judgment

          -  Women who are breast feeding or of child-bearing potential not using a highly
             effective method of birth control for at least one month prior to inclusion and at
             least 3 month after administration of trial medication.

        Hepatically impaired patients as determined by a hepatologist/gastroenterologist:

          -  Medical disorder, condition or history of such that would impair the patient's ability
             to participate or complete this study in the opinion of the investigator or the
             sponsor

          -  Patients with significant diseases other than underlying diagnose of hepatic
             impairment and concomitant diseases related to it. A significant disease is defined as
             a disease which in the opinion of the investigator:

               -  put the patient at risk because of participation in the study

               -  may influence the results of the study

               -  is not in a stable condition

          -  Surgery of the gastrointestinal tract that could interfere with the kinetics of the
             trial medication based on the investigator´s judgment

          -  Women who are breast feeding or of child-bearing potential not using a highly
             effective method of birth control for at least one month prior to inclusion and at
             least 3 month after administration of trial medication