Afatinib in Subjects With Kidney Dysfunction

• Status: Completed
• Trial end date: 2014-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Boehringer Ingelheim
• Treatments: Afatinib

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.