Renal Impairment Clinical Trial
Official title:
Pharmacokinetics of 20 mg BF2.649 in Single Dose, in Subjects With Normal Renal Function Compared to Subject With Impaired Renal Function
This is an open, parallel group study in subjects with normal renal function compared to those with renal dysfunction.
The pharmacokinetic of BF2.649 (pitolisant) is already well established from several studies
in healthy human, and a recent pharmacokinetic study gave data on 12 young healthy
volunteers compared to 12 elderly subject receiving 20mg/day during 14 days.
The aim of this study is to investigate effect of renal impairment on the pharmacokinetics
of BF2.649 administrated on a single oral dose of 20 mg.
The once daily dose of 20 mg BF2.649 (pitolisant) chosen for this study corresponds to the
usual therapeutic dose.
Twenty four subjects will be stratified according to renal function by using assessment of
glomerular filtration rate (GFR) as defined by MDRD formula as follows:
- 4 subjects from 18 to 75 years of age with mild impaired renal function defined by GFR
between 60 and 89 ml/min (STAGE 2 according to the international classification of
chronic kidney disease)
- 4 subjects from 18 to 75 years of age with moderate impaired renal function defined by
GFR between 30 and 59 ml/min (STAGE 3 according to the international classification of
chronic kidney disease)
- 4 subjects from 18 to 75 years of age with severe impaired renal function defined by
GFR between 15 and 29 ml/min (STAGE 4 according to the international classification of
chronic kidney disease)
- 12 healthy subjects with normal renal function defined by GFR>90 ml/min with no
proteinuria (<0.15g/L determined by urinalysis) matched with impaired renal function
subjects on ethnic group, sex, age (+/- 5 years), and BMI (+/- 20%)
;
Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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