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Pharmacokinetics of BF2.649 in Renal Impairment

Primary Purpose

Renal Impairment

Status

Completed

Phase

Phase 1

Locations

France

Study Type

Interventional

Intervention

BF2.649

About this trial

This is an interventional treatment trial for Renal Impairment focused on measuring Renal impairment

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

EUROFINS OPTIMED Lyon

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

impaired renal function subjects

Healthy volunteers

Arm Description

impaired renal function subjects

matched with impaired renal function subjects on ethnic group, sex, age (+/- 5 years), and BMI (+/- 20%)

Outcomes

Primary Outcome Measures

Mesure of classic pharmacokinetic parameters determined on BF2.649 serum and urine concentration

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

clinical safety of BF2.649.

change in lab tests (biological and clinical safety)

Full Information

NCT ID

NCT01619033

First Posted

July 20, 2011

Last Updated

April 11, 2013

Sponsor

Bioprojet

1. Study Identification

Unique Protocol Identification Number

NCT01619033

Brief Title

Pharmacokinetics of BF2.649 in Renal Impairment

Official Title

Pharmacokinetics of 20 mg BF2.649 in Single Dose, in Subjects With Normal Renal Function Compared to Subject With Impaired Renal Function

Study Type

Interventional

2. Study Status

Record Verification Date

April 2013

Overall Recruitment Status

Completed

Study Start Date

July 2011 (undefined)

Primary Completion Date

November 2012 (Actual)

Study Completion Date

November 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Bioprojet

4. Oversight

Data Monitoring Committee

5. Study Description

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%)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Renal Impairment

Keywords

Renal impairment

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

25 (Actual)

8. Arms, Groups, and Interventions

Arm Title

impaired renal function subjects

Arm Type

Experimental

Arm Description

impaired renal function subjects

Arm Title

Healthy volunteers

Arm Type

Other

Arm Description

matched with impaired renal function subjects on ethnic group, sex, age (+/- 5 years), and BMI (+/- 20%)

Intervention Type

Drug

Intervention Name(s)

BF2.649

Other Intervention Name(s)

Pitolisant

Intervention Description

single dose 20 mg

Primary Outcome Measure Information:

Title

Mesure of classic pharmacokinetic parameters determined on BF2.649 serum and urine concentration

Description

Cmax, Tmax, AUClast, AUC∞, λz, t½term, CL/F, Vz/F

Time Frame

between H0(0hr - Pre-dose) and H96 (96hr) after single oral dose

Secondary Outcome Measure Information:

Title

Number of Participants with Adverse Events as a Measure of Safety and Tolerability

Description

clinical safety of BF2.649.

Time Frame

during the 4 days following the drug administration

Title

change in lab tests (biological and clinical safety)

Time Frame

during 4 days after drug administration

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Claire POUTEIL-NOBLE, MD

Organizational Affiliation

Nephrologie, Centre Hospitalier Lyon Sud

Official's Role

Principal Investigator

Facility Information:

Facility Name

EUROFINS OPTIMED Lyon

City

Lyon

Country

France

12. IPD Sharing Statement

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Pharmacokinetics of BF2.649 in Renal Impairment

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