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Nintedanib in Volunteers With Hepatic Impairment Compared With Healthy Volunteers

Primary Purpose

Hepatic Insufficiency

Status

Completed

Phase

Phase 1

Locations

Germany

Study Type

Interventional

Intervention

Nintedanib

About this trial

This is an interventional treatment trial for Hepatic Insufficiency

Eligibility Criteria

18 Years - 79 Years (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

1199.200.49001 Boehringer Ingelheim Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

Mild liver impairment

Moderate liver impairment

Healthy volunteers

Arm Description

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

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

Healthy control subjects

Outcomes

Primary Outcome Measures

AUC (0-inf) of Nintedanib

AUC (0-inf) (Area under the concentration-time curve of the Nintedanib in plasma over the time interval from 0 extrapolated to infinity)

Cmax of Nintedanib

Cmax (Maximum measured concentration of the Nintedanib in plasma)

Secondary Outcome Measures

AUC (0-tz) of Nintedanib

AUC (0-tz) (Area under the concentration-time curve of the Nintedanib in plasma over the time interval from 0 to the last quantifiable drug plasma concentration)

Number (%) of Subjects With Drug-related Adverse Events (AEs)

Number (%) of subjects with drug-related Adverse events (AEs)

Full Information

NCT ID

NCT02191865

First Posted

July 14, 2014

Last Updated

December 21, 2015

Sponsor

Boehringer Ingelheim

1. Study Identification

Unique Protocol Identification Number

NCT02191865

Brief Title

Nintedanib in Volunteers With Hepatic Impairment Compared With Healthy Volunteers

Official Title

Pharmacokinetics, Safety and Tolerability of Nintedanib Single Oral Dose in Male and Female Patients With Different Degrees of Hepatic Impairment (Child-Pugh Classification A and B) as Compared With Nintedanib Administration to Male and Female Healthy Subjects (a Non-blinded, Parallel Group Study of Phase I)

Study Type

Interventional

2. Study Status

Record Verification Date

December 2015

Overall Recruitment Status

Completed

Study Start Date

July 2014 (undefined)

Primary Completion Date

December 2014 (Actual)

Study Completion Date

January 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Boehringer Ingelheim

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hepatic Insufficiency

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

33 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Mild liver impairment

Arm Type

Experimental

Arm Description

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

Arm Title

Moderate liver impairment

Arm Type

Experimental

Arm Description

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

Arm Title

Healthy volunteers

Arm Type

Experimental

Arm Description

Healthy control subjects

Intervention Type

Drug

Intervention Name(s)

Nintedanib

Intervention Description

Soft gelatine capsule

Intervention Type

Drug

Intervention Name(s)

Nintedanib

Intervention Description

Soft gelatine capsule

Intervention Type

Drug

Intervention Name(s)

Nintedanib

Intervention Description

Soft gelatine capsule

Primary Outcome Measure Information:

Title

AUC (0-inf) of Nintedanib

Description

AUC (0-inf) (Area under the concentration-time curve of the Nintedanib in plasma over the time interval from 0 extrapolated to infinity)

Time Frame

Pre-dose and 1 hour (h), 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 72h, 96h, 120h, 144h and 168h after drug administration

Title

Cmax of Nintedanib

Description

Cmax (Maximum measured concentration of the Nintedanib in plasma)

Time Frame

Pre-dose and 1 hour (h), 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 72h, 96h, 120h, 144h and 168h after drug administration

Secondary Outcome Measure Information:

Title

AUC (0-tz) of Nintedanib

Description

AUC (0-tz) (Area under the concentration-time curve of the Nintedanib in plasma over the time interval from 0 to the last quantifiable drug plasma concentration)

Time Frame

Pre-dose and 1 hour (h), 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 72h, 96h, 120h, 144h and 168h after drug administration

Title

Number (%) of Subjects With Drug-related Adverse Events (AEs)

Description

Number (%) of subjects with drug-related Adverse events (AEs)

Time Frame

(AEs) during the 'on-treatment' period (from administration of trial medication until the end of the 28-day residual effect period); Up to 29 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

79 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Boehringer Ingelheim

Organizational Affiliation

Boehringer Ingelheim

Official's Role

Study Chair

Facility Information:

Facility Name

1199.200.49001 Boehringer Ingelheim Investigational Site

City

Kiel

Country

Germany

12. IPD Sharing Statement

Links:

URL

http://trials.boehringer-ingelheim.com

Description

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Nintedanib in Volunteers With Hepatic Impairment Compared With Healthy Volunteers

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