Afatinib in Subjects With Kidney Dysfunction

Phase 1

Completed

• Conditions: Renal Insufficiency
• Interventions: Drug: Afatinib moderate renally impaired; Drug: Afatinib severe renally impaired; Drug: Afatinib healthy

• Registration Number: NCT02096718
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

The primary objective of the current study is to investigate the influence of moderate to severe renal impairment on the pharmacokinetics and safety of a single dose afatinib in comparison to a control group with normal renal function.

The assessment of safety and tolerability will be an additional objective of this trial and will be evaluated by descriptive statistics.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-03-24
• Study First Submitted QC: 2014-03-24
• Study First Posted: 2014-03-26
• Study Start: 2014-05
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Status Verified: 2015-11
• Results First Submitted: 2015-12-09
• Results First Submitted QC: 2015-12-09
• Last Update Submitted: 2015-12-09
• Results First Posted: 2016-01-14
• Last Update Posted: 2016-01-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Afatinib in moderate renal impaired	Afatinib moderate renally impaired	Single Dose Afatinib in moderate renal impaired subjects
Afatinib in severe renal impaired	Afatinib severe renally impaired	Single Dose Afatinib in severe renal impaired subjects
Afatinib in healthy subjects	Afatinib healthy	Single Dose Afatinib in healthy subjects matched by gender, race, age and BMI to moderate and severe renal impaired subjects

Primary Outcome Measures

Name	Time	Method
AUC 0-tz of Afatinib (BIBW 2992)	PK plasma samples were taken at: 1 hour before drug administration and 0.5 hour (h), 1h, 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 7h, 8h, 9h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 192h, 240h, 312h after first drug administration	Area under the concentration-time curve of the analyte in plasma over the time interval from 0 up to the last quantifiable data point
Cmax of Afatinib (BIBW 2992)	PK plasma samples were taken at: 1 hour before drug administration and 0.5 hour (h), 1h, 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 7h, 8h, 9h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 192h, 240h, 312h after first drug administration	Maximum measured concentration of the analyte in plasma

Secondary Outcome Measures

Name	Time	Method
AUC 0-inf of Afatinib (BIBW 2992)	PK plasma samples were taken at: 1 hour before drug administration and 0.5 hour (h), 1h, 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 7h, 8h, 9h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 192h, 240h, 312h after first drug administration	Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity

Trial Locations

Locations (1)

1200.216.1 Boehringer Ingelheim Investigational Site; 🇩🇪 Kiel, Germany