Clinical Trials Logo

Clinical Trial Summary

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


Clinical Trial 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%) ;


Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT01619033
Study type Interventional
Source Bioprojet
Contact
Status Completed
Phase Phase 1
Start date July 2011
Completion date November 2012

See also
  Status Clinical Trial Phase
Completed NCT01937975 - The Pharmacokinetics of Grazoprevir (MK-5172) and Elbasvir (MK-8742) in Participants With Renal Insufficiency (MK-5172-050) Phase 1
Completed NCT03284164 - Evaluation of Effect of Renal Impairment on the PK of Tenofovir Exalidex Phase 1
Completed NCT05992155 - A Study of TAK-279 in Adults With or Without Kidney Problems Phase 1
Completed NCT05004311 - The Effect of Severe Kidney Impairment on Cenerimod Pharmacokinetics Phase 1
Completed NCT04963738 - A Study of JNJ-73763989 in Adult Participants With Renal Impairment Phase 1
Terminated NCT02508740 - Single Oral Dose of Bevenopran in Patients With Varying Degrees of Renal Impairment Phase 1
Active, not recruiting NCT01529658 - Renal Hypothermia During Partial Nephrectomy N/A
Terminated NCT00984113 - Pharmacokinetics of Elinogrel in Healthy Volunteers and Patients With Mild, Moderate, and Severe Renal Impairment Phase 1
Completed NCT00750620 - A Pharmacokinetic Study of YM178 in Normal Subjects and Those With Mild, Moderate, and Severe Renal Impairment Phase 1
Completed NCT00842868 - The CASABLANCA Study: Catheter Sampled Blood Archive in Cardiovascular Diseases N/A
Completed NCT00499187 - Fanconi Syndrome Due to ARVs in HIV-Infected Persons Phase 4
Completed NCT01331941 - A Pharmacokinetic Study of AMG 386 in Cancer Subjects With Normal and Impaired Renal Function Phase 1
Completed NCT05489614 - A Study to Evaluate the Pharmacokinetics, Safety, and Pharmacodynamics of Olpasiran in Participants With Normal Renal Function and Participants With Various Degrees of Renal Impairment Phase 1
Completed NCT03259087 - Pharmacokinetics (PK) and Safety of a Single Intravenous (IV) Dose of MK-3866 in Participants With Impaired Renal Function and in Healthy Controls (MK-3866-005) Phase 1
Completed NCT05086107 - Pharmacokinetics and Safety of BV100 Administered as Single Intravenous Infusion to Subjects With Renal Impairment Phase 1
Recruiting NCT05349851 - Bowel Cleansing With Renal Impairment
Completed NCT03660241 - A Renal Impairment Study for PF-04965842 Phase 1
Recruiting NCT06037031 - A Study to Learn How the Body Processes the Study Medicine Called PF-07923568 in People With Loss of Kidney Function Phase 1
Completed NCT03289208 - Pharmacokinetics Study of MCI-186 in Subjects With Mild or Moderate Renal Impairment Phase 1
Completed NCT02942810 - To Investigate The Pharmacokinetics Of Intravenous WCK 5222 (FEP-ZID) In Patients With Renal Impairment Phase 1