Pharmacokinetics of BF2.649 in Renal Impairment

NCT01619033 | Completed Phase 1

• 2 other identifiers: P09-13 / BF2.6492011-001430-42
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Renal Impairment

Keywords

Renal impairment

Outcome Measures

Primary Outcomes (1)

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

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

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

Secondary Outcomes (2)

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

  during the 4 days following the drug administration

• change in lab tests (biological and clinical safety)

  during 4 days after drug administration

Study Arms (2)

impaired renal function subjects

EXPERIMENTAL

impaired renal function subjects

Drug: BF2.649

Healthy volunteers

OTHER

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

Drug: BF2.649

Interventions

BF2.649 DRUG

single dose 20 mg

Also known as: Pitolisant

Healthy volunteers; impaired renal function subjects

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bioprojet: lead

Study Sites (1)

EUROFINS OPTIMED Lyon

Lyon, France

Location

MeSH Terms

Conditions

Renal Insufficiency

Interventions

pitolisant

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Claire POUTEIL-NOBLE, MD

  Nephrologie, Centre Hospitalier Lyon Sud

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2011
• First Posted: June 14, 2012
• Study Start: July 1, 2011
• Primary Completion: November 1, 2012
• Study Completion: November 1, 2012
• Last Updated: April 12, 2013

Record last verified: 2013-04

Locations

FR (1)