Phase 1
Completed N=30
Afatinib in Subjects With Kidney Dysfunction
Source: ClinicalTrials.gov NCT02096718 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Jan 2016
Primary outcomePrimary: AUC 0-tz of Afatinib (BIBW 2992) — 948; 952; 776; 634 ng*h/mL
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY AUC 0-tz of Afatinib (BIBW 2992) |
948; 952; 776; 634 | — |
| PRIMARY Cmax of Afatinib (BIBW 2992) |
28.7; 28.2; 28.3; 23.2 | — |
| SECONDARY AUC 0-inf of Afatinib (BIBW 2992) |
976; 980; 797; 653 | — |
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 140 mmHg, diastolic blood pressure 90 mmHg, repeated measurement of pulse rate 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.
Data sourced from ClinicalTrials.gov (NCT02096718). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.