Nintedanib in Volunteers With Hepatic Impairment Compared With Healthy Volunteers

NCT02191865 | Completed Phase 1 Results

• 2 other identifiers: 1199.2002014-000690-39
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• 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)

  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

• Cmax of Nintedanib

  Cmax (Maximum measured concentration of the Nintedanib in plasma)

  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 Outcomes (2)

• AUC (0-tz) of Nintedanib

  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

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

  (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

Study Arms (3)

Mild liver impairment

EXPERIMENTAL

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

Drug: Nintedanib

Moderate liver impairment

EXPERIMENTAL

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

Drug: Nintedanib

Healthy volunteers

EXPERIMENTAL

Healthy control subjects

Drug: Nintedanib

Interventions

Nintedanib DRUG

Soft gelatine capsule

Moderate liver impairment

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (1)

1199.200.49001 Boehringer Ingelheim Investigational Site

Kiel, Germany

Location

MeSH Terms

Conditions

Hepatic Insufficiency

Interventions

nintedanib

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases

Results Point of Contact

• Title: Boehringer Ingelheim Call Center
• Organization: Boehringer Ingelheim

clintriage.rdg@boehringer-ingelheim.com

800-243-0127

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2014
• First Posted: July 16, 2014
• Study Start: July 1, 2014
• Primary Completion: December 1, 2014
• Study Completion: January 1, 2015
• Last Updated: February 1, 2016
• Results First Posted: February 1, 2016

Record last verified: 2015-12

Locations

DE (1)