Nintedanib in Volunteers With Hepatic Impairment Compared With Healthy Volunteers

NCT ID: NCT02191865

Last Updated: 2016-02-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-07-31
• Study Completion Date: 2015-01-31

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 tolerability of nintedanib, in comparison with a control group with normal hepatic function following oral administration of nintedanib as single dose.

Conditions

Hepatic Insufficiency

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Mild liver impairment

Patients with mild hepatic impaired function (Child-Pugh A)

Group Type: EXPERIMENTAL

Nintedanib

Intervention Type: DRUG

Soft gelatine capsule

Moderate liver impairment

Patients with moderate hepatic impaired function (Child-Pugh B)

Group Type: EXPERIMENTAL

Nintedanib

Intervention Type: DRUG

Soft gelatine capsule

Healthy volunteers

Healthy control subjects

Group Type: EXPERIMENTAL

Nintedanib

Intervention Type: DRUG

Soft gelatine capsule

Interventions

Nintedanib

Soft gelatine capsule

Intervention Type: DRUG

Nintedanib

Soft gelatine capsule

Intervention Type: DRUG

Nintedanib

Soft gelatine capsule

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 79 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

1199.200.49001 Boehringer Ingelheim Investigational Site

Kiel, , Germany

Countries

Germany

Other Identifiers

2014-000690-39

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

1199.200

Identifier Type: -

Identifier Source: org_study_id