Pharmacokinetics of BF2.649 in Renal Impairment - Full Text View

Purpose

This is an open, parallel group study in subjects with normal renal function compared to those with renal dysfunction.

Condition	Intervention	Phase
Renal Impairment	Drug: BF2.649	Phase 1

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Pharmacokinetics of 20 mg BF2.649 in Single Dose, in Subjects With Normal Renal Function Compared to Subject With Impaired Renal Function

Further study details as provided by Bioprojet:

Primary Outcome Measures:

Mesure of classic pharmacokinetic parameters determined on BF2.649 serum and urine concentration [ Time Frame: between H0(0hr - Pre-dose) and H96 (96hr) after single oral dose ] [ Designated as safety issue: Yes ]
Cmax, Tmax, AUClast, AUC∞, λz, t½term, CL/F, Vz/F

Secondary Outcome Measures:

Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: during the 4 days following the drug administration ] [ Designated as safety issue: Yes ]
clinical safety of BF2.649.
change in lab tests (biological and clinical safety) [ Time Frame: during 4 days after drug administration ] [ Designated as safety issue: Yes ]

Enrollment:	25
Study Start Date:	July 2011
Study Completion Date:	November 2012
Primary Completion Date:	November 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: impaired renal function subjects impaired renal function subjects	Drug: BF2.649 single dose 20 mg Other Name: Pitolisant
Healthy volunteers matched with impaired renal function subjects on ethnic group, sex, age (+/- 5 years), and BMI (+/- 20%)	Drug: BF2.649 single dose 20 mg Other Name: Pitolisant

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%)

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

For subjects with impaired renal function:

Subjects 18 to 75 years old with impaired renal function (MDRD formula between 15 and 89mL/min) medically stable since 3 months
With body mass index (weight/height2) in the range 18 to 32 kg/m2 (inclusive)

For healthy subjects:

Healthy subjects 18 to 75 years old with normal renal function (MDRD > 90 mL/min) and no proteinuria (<0.15g/L determined by urinalysis) matched with impaired renal function subjects on ethnic group, sex, age (+/- 5 years), and BMI (+/- 20%)

Exclusion Criteria:

For impaired renal function subjects:

History of hepatic, cardiovascular (including conduction disturbance) or psychiatric disorder or any other condition which, in the opinion of the investigator, would jeopardize the safety of the subject or impact the validity of study results.
Evidence of liver disease
Presence of concomitant pathology requiring intake of any drugs or substances known to be inhibitors or inductors of CYP enzymes
Presence of metabolic or ionic disorders not controlled by adapted treatment
Presence of significant anemia,nephrotic syndrome
Renal transplantation

For healthy subjects:

history of renal, cardiovascular, gastrointestinal, hepatic, neurological, endocrine or psychiatric disorders or any surgery which puts them at risk in the opinion of the investigator.
Any treatment within 14 days before inclusion, or within 5 times the elimination half-life of that drug, whichever the longest, including treatment which could lead to inhibition or induction of CYP enzymes - mainly CYP3A4 and CYP2D6 and with the exception of hormonal contraception and menopausal hormone replacement therapy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01619033

Locations

France
EUROFINS OPTIMED Lyon
Lyon, France

Sponsors and Collaborators

Bioprojet

Investigators

Principal Investigator:

Claire POUTEIL-NOBLE, MD

Nephrologie, Centre Hospitalier Lyon Sud

More Information

No publications provided

Responsible Party:	Bioprojet
ClinicalTrials.gov Identifier:	NCT01619033 History of Changes
Other Study ID Numbers:	P09-13 / BF2.649, 2011-001430-42
Study First Received:	July 20, 2011
Last Updated:	April 11, 2013
Health Authority:	France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) Bulgaria: Bulgarian Drug Agency

Keywords provided by Bioprojet:

Renal impairment

Additional relevant MeSH terms:

Renal Insufficiency
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on June 17, 2013