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A Study of the Effects of Renal Impairment on the Pharmacokinetics and Tolerability of Eliglustat Tartrate

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ClinicalTrials.gov Identifier: NCT02536937
Recruitment Status : Completed
First Posted : September 1, 2015
Last Update Posted : March 8, 2017
Sponsor:
Information provided by (Responsible Party):
Sanofi

Tracking Information
First Submitted Date  ICMJE August 28, 2015
First Posted Date  ICMJE September 1, 2015
Last Update Posted Date March 8, 2017
Study Start Date  ICMJE September 2015
Actual Primary Completion Date January 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 28, 2015)
  • - Assessment of PK parameter: Maximum plasma concentration observed (Cmax) [ Time Frame: 3 days ]
  • - Assessment of PK parameter: Area under the plasma concentration (AUC) [ Time Frame: 3 days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 28, 2015)
  • Assessment of PK parameter: Area under the plasma concentration versus time curve (AUClast) [ Time Frame: 3 days ]
  • Assessment of PK parameter: Apparent total body clearance (CL/F) [ Time Frame: 3 days ]
  • Assessment of PK parameter: Apparent volume of distribution during the terminal phase (Vz/F) [ Time Frame: 3 days ]
  • Assessment of PK parameter: Predicted accumulation ratio (Rac,pred) [ Time Frame: 3 days ]
  • Assessment of PK parameter: Terminal half-life (t1/2z) [ Time Frame: 3 days ]
  • Number of adverse events [ Time Frame: Up to 10 days ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of the Effects of Renal Impairment on the Pharmacokinetics and Tolerability of Eliglustat Tartrate
Official Title  ICMJE An Open-label Two-stage Pharmacokinetic and Tolerability Study of Eliglustat Tartrate Given as a Single Dose in Subjects With Mild, Moderate and Severe Renal Impairment, and in Matched Subjects With Normal Renal Function
Brief Summary

Primary Objective:

To study the effect of mild, moderate, and severe renal impairment on the pharmacokinetics (PK) of eliglustat.

Secondary Objective:

To assess the tolerability of eliglustat tartrate given as a single dose in subjects with mild, moderate, and severe renal impairment in comparison with matched subjects with normal renal function.

Detailed Description The total study duration from screening period is approximately 31 days. In stage 1, only subjects with severe renal impairment and normal renal function will be enrolled. Subjects with mild and moderate renal impairment may be enrolled in stage 2 if the results in subjects with severe renal impairment show a substantial effect of reduced renal function on pharmacokinetics.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Gaucher Disease
Intervention  ICMJE Drug: eliglustat

Pharmaceutical form: capsule

Route of administration: oral

Other Name: GZ385660
Study Arms  ICMJE
  • Experimental: GZ385660 (healthy subjects)
    Single dose of eliglustat tartrate will be given under fed conditions
    Intervention: Drug: eliglustat
  • Experimental: GZ385660 (subjects with mild renal impairment)
    Single dose of eliglustat tartrate will be given under fed conditions
    Intervention: Drug: eliglustat
  • Experimental: GZ385660 (subjects with moderate renal impairment)
    Single dose of eliglustat tartrate will be given under fed conditions
    Intervention: Drug: eliglustat
  • Experimental: GZ385660 (subjects with severe renal impairment)
    Single dose of eliglustat tartrate will be given under fed conditions
    Intervention: Drug: eliglustat
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 28, 2015)
32
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 2017
Actual Primary Completion Date January 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion criteria :

For renal impaired:

  • Male or female subjects, between 18 and 79 years of age, inclusive.
  • Body weight between 50.0 kg and 125.0 kg inclusive if male, between 40.0 kg and 110.0 kg inclusive if female, body mass index (BMI) between 18.0 and 37.0 kg/m^2, inclusive.
  • Stable chronic renal impairment, as defined by Cockroft-Gault formula.
  • For severe renal impairment: CrCl <30 mL/min.
  • For moderate renal impairment: 30 mL/min ≤CrCl <50 mL/min.
  • For mild renal impairment: 50 mL/min ≤CrCl ≤80 mL/min.

For matched subjects:

  • Male or female subject, between 18 and 79 years inclusive, matched by age.
  • Body weight within 15% of the body weight of the subjects with renal impairment to be matched and BMI between 18.0 and 37.0 mg/kg^2 inclusive.
  • Matched by cytochrome P450 (CYP) 2D6 predicted phenotype based on genotype.
  • Certified as healthy by a comprehensive clinical assessment (detailed medical history and complete physical examination).
  • For healthy subjects: CrCl >80 mL/min.

Exclusion criteria:

For renal impairment patients:

  • Uncontrolled clinically relevant cardiovascular, pulmonary, gastrointestinal, metabolic, hematological, neurological, psychiatric, systemic, ocular, gynecologic (if female) or infectious disease, or signs of acute illness.
  • Active hepatitis, hepatic insufficiency.
  • Acute renal failure (de novo or superimposed to pre-existing chronic renal impairment), nephrotic syndrome.
  • History of or current hematuria of urologic origin that limits the subject's participation in the study.
  • Subjects requiring dialysis during the study.
  • Presence or history of drug hypersensitivity, or allergic disease diagnosed and treated by a physician.
  • If female, pregnancy (defined as positive beta-human chorionic gonadotropin [β-hCG] blood test), breastfeeding.
  • Any significant change in chronic treatment medication within 14 days before inclusion.
  • P-gp inhibitors and/or inducers, CYP2D6 and/or CYP3A inducers, and strong and/or moderate CYP2D6 and/or CYP3A inhibitors. Up to one weak CYP2D6 inhibitor and/or one weak CYP3A inhibitor are allowed (as defined in The Metabolism and Transport Drug Interaction Database™ (DIDB).
  • Positive result on any of the following tests: anti-human immunodeficiency virus 1 and 2 antibodies (anti-HIV1 and anti-HIV2 Ab).
  • Pre-existing cardiac disease (current congestive heart failure, recent acute myocardial infarction, bradycardia, heart block, ventricular arrhythmia), long QT syndrome, or use of Class IA (eg, quinidine, procainamide) and Class III (eg, amiodarone, sotalol) anti-arrhythmic medications.
  • Any subject with CYP2D6 indeterminate or ultra-rapid metabolizer (URM) phenotype.

For matched volunteers:

  • Any history or presence of clinically relevant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, metabolic, hematological, neurological, osteomuscular, articular, psychiatric, systemic, ocular, gynecologic (if female), or infectious disease, or signs of acute illness.
  • Presence or history of drug hypersensitivity, or allergic disease diagnosed and treated by a physician.
  • If female, pregnancy (defined as positive β-hCG blood test), breast feeding.
  • For subjects 50 years old and below: any medication (including St John's Wort) within 14 days before inclusion, or within 5 times the elimination half-life or pharmacodynamic half-life of that medication, whichever is longest, with the exception of hormonal contraception or menopausal hormone replacement therapy; any vaccination within the last 28 days, and any biologics (antibody or its derivatives) within 4 months before inclusion.
  • For subjects above 50 years old: any significant change in chronic treatment medication within 14 days before inclusion.
  • P-gp inhibitors and/or inducers, CYP2D6 and/or CYP3A inducers, and strong and/or moderate CYP2D6 and/or CYP3A inhibitors. Up to one weak CYP2D6 inhibitor and/or one weak CYP3A inhibitor are allowed (as defined in The Metabolism and Transport Drug Interaction Database™ (DIDB).
  • Positive result on any of the following tests: hepatitis B surface antigen (HBsAg), anti-hepatitis C virus (anti-HCV) Ab, anti-HIV1 and anti-HIV2 Ab.
  • Pre-existing cardiac disease (current congestive heart failure, recent acute myocardial infarction, bradycardia, heart block, ventricular arrhythmia), long QT syndrome, or use of Class IA (eg, quinidine, procainamide) and Class III (eg, amiodarone, sotalol) anti-arrhythmic medications.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 79 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02536937
Other Study ID Numbers  ICMJE POP13778
U1111-1170-3686 ( Other Identifier: UTN )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sanofi
Study Sponsor  ICMJE Sanofi
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Sciences & Operations Sanofi
PRS Account Sanofi
Verification Date March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP