Status:
COMPLETED
Nintedanib in Volunteers With Hepatic Impairment Compared With Healthy Volunteers
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Hepatic Insufficiency
Eligibility:
All Genders
18-79 years
Phase:
PHASE1
Brief 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 tolerab...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
July 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2015
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT02191865
Start Date
July 1 2014
End Date
January 1 2015
Last Update
February 1 2016
Active Locations (1)
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1
1199.200.49001 Boehringer Ingelheim Investigational Site
Kiel, Germany