Afatinib in Subjects With Kidney Dysfunction

NCT ID: NCT02096718

Last Updated: 2016-01-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-05-31
• Study Completion Date: 2014-12-31

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.

Conditions

Renal Insufficiency

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Afatinib in moderate renal impaired

Single Dose Afatinib in moderate renal impaired subjects

Group Type: EXPERIMENTAL

Afatinib moderate renally impaired

Intervention Type: DRUG

Afatinib in severe renal impaired

Single Dose Afatinib in severe renal impaired subjects

Group Type: EXPERIMENTAL

Afatinib severe renally impaired

Intervention Type: DRUG

Afatinib in healthy subjects

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

Group Type: OTHER

Afatinib healthy

Intervention Type: DRUG

Interventions

Afatinib healthy

Intervention Type: DRUG

Afatinib severe renally impaired

Intervention Type: DRUG

Afatinib moderate renally impaired

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Despite renal impairment (group 1 and 2) healthy males or females according to the investigators assessment, as based on the following criteria: a complete medical history including a physical examination, vital signs (Blood Pressure (BP), Pulse Rate (PR)), 12-lead Electrocardiogram (ECG), and clinical laboratory tests.
• Glomerular filtration rate (GFR), estimated according to:

-- MDRD (Modification of Diet in Renal Disease)-formula:

• eGFR (estimated Glomerular Filtration Rate) [ml/min/1.73m²]= 175 x Serum Creatinine-1.154 x age-0.203 (if male)
• eGFR[ml/min/1.73m²]= 175 x Serum Creatinine-1.154 x age-0.203 x 0.742 (if female)
• 30 to 59 mL/min for moderate renal impairment group 1
• 15 to 29 mL/min for severe renal impairment group 2
• = 90 mL/min for healthy volunteers group 3
• Age =18 and =79 years

Exclusion Criteria

• Any finding of the medical examination (including Blood Pressure (BP), Pulse Rate (PR) and Electrocardiogram (ECG)) deviating from normal and of clinical relevance, e.g. repeated measurement of systolic blood pressure < 90 mmHg (millimeter of mercury) or > 140 mmHg, diastolic blood pressure < 50 mmHg or > 90 mmHg, repeated measurement of pulse rate < 45 bpm (beats per minute) or > 90 bpm.
• Any evidence of a clinically relevant concomitant disease.
• Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological, dermatological or hormonal disorders.
• Relevant gastrointestinal tract surgery (except appendectomy).
• Diseases of the central nervous system (such as epilepsy, seizures) or psychiatric disorders or neurological disorders.
• History of photosensitivity or recurrent rash.
• Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 79 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

1200.216.1 Boehringer Ingelheim Investigational Site

Kiel, , Germany

Countries

Germany

References

Wiebe S, Schnell D, Kulzer R, Gansser D, Weber A, Wallenstein G, Halabi A, Conrad A, Wind S. Influence of Renal Impairment on the Pharmacokinetics of Afatinib: An Open-Label, Single-Dose Study. Eur J Drug Metab Pharmacokinet. 2017 Jun;42(3):461-469. doi: 10.1007/s13318-016-0359-9.

Reference Type: DERIVED

PMID: 27436099 (View on PubMed)

Other Identifiers

2013-004825-98

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

1200.216

Identifier Type: -

Identifier Source: org_study_id