Influence of Mild and Moderate Hepatic Impairment on the Pharmacokinetics, Safety and Tolerability of Various Doses of Afatinib

Phase 1

Completed

• Conditions: Healthy; Liver Diseases
• Interventions: Drug: Afatinib

• Registration Number: NCT01298063
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

Up to 38 subjects entered with the aim of entering 8 subjects with mild liver impairment (at highest dose of afatinib), 8 subjects with moderate liver impairment (at either highest dose or two lower doses) and 8 healthy matched controls to each of this two groups.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-02
• Study First Submitted: 2011-02-15
• Study First Submitted QC: 2011-02-16
• Study First Posted: 2011-02-17
• Primary Completion: 2012-01
• Status Verified: 2013-08
• Results First Submitted: 2013-08-08
• Results First Submitted QC: 2013-08-08
• Results First Posted: 2013-10-17
• Last Update Submitted: 2013-12-05
• Last Update Posted: 2013-12-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Afatinib Group A, B (2), D	Afatinib	healthy subjects, mild and moderate liver impaired subjects to receive one single dose treatment containing the highest dose afatinib
Afatinib Group B (3), D	Afatinib	healthy subjects, moderate liver impaired subjects to receive one single dose treatment containing the medium dose of afatinib
Afatinib Group B (1), D	Afatinib	healthy subjects, moderate liver impaired subjects to receive one single dose treatment containing the low dose of afatinib

Primary Outcome Measures

Name	Time	Method
Area Under Curve From 0 to Infinity (AUC0-infinity)	30 minutes (min) prior to first dosing and 30 min, 1 hour (h), 2 h, 3 h, 4 h, 5 h, 6 h, 7 h, 8 h, 9 h, 12 h, 24 h, 36 h, 48 h, 72 h, 96 h, 120 h, 144 h, 168 h, 240 h after first dosing	AUC0-infinity represents the area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity
Maximum Concentration (Cmax)	30 minutes (min) prior to first dosing and 30 min, 1 hour (h), 2 h, 3 h, 4 h, 5 h, 6 h, 7 h, 8 h, 9 h, 12 h, 24 h, 36 h, 48 h, 72 h, 96 h, 120 h, 144 h, 168 h, 240 h after first dosing	Cmax represents the maximum measured concentration of the analyte in plasma

Secondary Outcome Measures

Name	Time	Method
Area Under Curve From 0 to tz (AUC0-tz)	30 minutes (min) prior to first dosing and 30 min, 1 hour (h), 2 h, 3 h, 4 h, 5 h, 6 h, 7 h, 8 h, 9 h, 12 h, 24 h, 36 h, 48 h, 72 h, 96 h, 120 h, 144 h, 168 h, 240 h after first dosing	AUC0-tz represents the area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point
Clinical Relevant Abnormalitites for Physical Examination, Vital Signs, 12-lead ECG, Clinical Laboratory Tests, Adverse Event, Investigator's Global Tolerability	First administration of trial medication until 28 days after last administration of trial medication	Clinical relevant abnormalitites for physical examination, vital signs, 12-lead electrocardiogramm (ECG), clinical laboratory test (including hematology, clinical chemistry, coagulation, urinalysis), adverse event, investigator's global tolerability. New abnormal findings or worsening of baseline conditions were reported as Adverse Events.

Trial Locations

Locations (1)

1200.86.1 Boehringer Ingelheim Investigational Site; 🇩🇪 Kiel, Germany