Nintedanib in Volunteers With Hepatic Impairment Compared With Healthy Volunteers

Boehringer Ingelheim

Status and phase: Completed; Phase 1

Conditions: Hepatic Insufficiency

Treatments: Drug: Nintedanib

Study type: Interventional

Funder types: Industry

Identifiers

NCT02191865

1199.200

2014-000690-39 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 33 patients

Sex: All

Ages: 18 to 79 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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33 participants in 3 patient groups

Mild liver impairment

Experimental group

Description:

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

Treatment:

Drug: Nintedanib

Drug: Nintedanib

Drug: Nintedanib

Moderate liver impairment

Experimental group

Description:

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

Treatment:

Drug: Nintedanib

Drug: Nintedanib

Drug: Nintedanib

Healthy volunteers

Experimental group

Description:

Healthy control subjects

Treatment:

Drug: Nintedanib

Drug: Nintedanib

Drug: Nintedanib