Ignite Creation Date:
2025-12-25 @ 2:42 AM
Ignite Modification Date:
2025-12-27 @ 10:57 PM
Study NCT ID:
NCT01619033
Status:
COMPLETED
Last Update Posted:
2013-04-12
First Post:
2011-07-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pharmacokinetics of BF2.649 in Renal Impairment
Sponsor:
Bioprojet
Organization:
Study Overview
Official Title:
Pharmacokinetics of 20 mg BF2.649 in Single Dose, in Subjects With Normal Renal Function Compared to Subject With Impaired Renal Function
Status:
COMPLETED
Status Verified Date:
2013-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is an open, parallel group study in subjects with normal renal function compared to those with renal dysfunction.
Detailed Description:
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%)
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%)
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2011-001430-42 | EUDRACT_NUMBER | None | View |