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Influence of Mild and Moderate Hepatic Impairment on the Pharmacokinetics, Safety and Tolerability of Various Doses of Afatinib | Clinical Trials | Clareo Health

COMPLETEDPHASE1

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

Pharmacokinetics, Safety and Tolerability of Different Oral Doses of Afatinib, in Subjects With Mild to Moderate Hepatic Impairment Compared to Healthy Subjects - a Phase I, Single-dose, Open-label, Dose-escalation Study in a Matched Group Design

NCT01298063•Boehringer Ingelheim

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Healthy subjects:
•1. Healthy males and females according to a complete medical history, including a physical examination, vital signs (Blood Pressure, Pulse Rate), 12-lead Electrocardiogram, and clinical laboratory tests. The healthy subjects must meet the matching criteria based on the matching approach (cf. Section 3.3).
•2. Age =18 and =75 years
•3. Body Mass Index =18.5 and =34 kg/m2
•4. Creatinine clearance \>70 mL/min according to Cockroft \& Gault (for healthy volunteers, cf. Section 10.2)
•5. Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice and the local legislation. Hepatically impaired subjects as determined by a hepatologist/ gastroenterologist:
•6. Male and female liver impaired subjects determined by results of screening classified as Child-Pugh A; Child-Pugh score of 5-6 points or as Child-Pugh B; Child-Pugh score of 7-9 points, cf. Section 10.2. Child-Pugh criteria must be stable for at least 3 months prior to screening and during the trial.
•7. Age =18 and =75 years
•8. Body Mass Index =18.5 and =34 kg/m2
•9. Creatinine clearance \>40 mL/min according to Cockroft \& Gault (for liver impaired subjects, cf. Section 10.2)
+3 more criteria

Exclusion Criteria

•Any relevant deviation from healthy conditions (excluded conditions caused by liver impairment)

Locations (1)

1200.86.1 Boehringer Ingelheim Investigational Site

Kiel, Germany

Key Dates

Start Date

February 1, 2011

Primary Completion Date

January 1, 2012

Last Updated

December 31, 2013

Enrollment

ACTUAL participants

Conditions

Liver DiseasesHealthy

Interventions

Afatinib

DRUG

Afatinib

DRUG

Afatinib

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 31, 2013Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Collection of Data and Samples From Healthy Donors for Use in Translational Research

Fecal Microbiota Transplantation for Patients With Autism Spectrum Disorder.

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