Nintedanib in Volunteers With Hepatic Impairment Compared With Healthy Volunteers

Phase 1

Completed

• Conditions: Hepatic Insufficiency
• Interventions: Drug: Nintedanib

• Registration Number: NCT02191865
• Lead Sponsor: Boehringer Ingelheim

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-07
• Study First Submitted: 2014-07-14
• Study First Submitted QC: 2014-07-14
• Study First Posted: 2014-07-16
• Primary Completion: 2014-12
• Study Completion: 2015-01
• Status Verified: 2015-12
• Results First Submitted: 2015-12-21
• Results First Submitted QC: 2015-12-21
• Last Update Submitted: 2015-12-21
• Results First Posted: 2016-02-01
• Last Update Posted: 2016-02-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Healthy volunteers	Nintedanib	Healthy control subjects
Mild liver impairment	Nintedanib	Patients with mild hepatic impaired function (Child-Pugh A)
Moderate liver impairment	Nintedanib	Patients with moderate hepatic impaired function (Child-Pugh B)

Primary Outcome Measures

Name	Time	Method
AUC (0-inf) 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	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	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 (Maximum measured concentration of the Nintedanib in plasma)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

1199.200.49001 Boehringer Ingelheim Investigational Site; 🇩🇪 Kiel, Germany