NCT02536937

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Sep 2015

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 28, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 1, 2015

Completed
Same day until next milestone

Study Start

First participant enrolled

September 1, 2015

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

March 8, 2017

Status Verified

March 1, 2017

Enrollment Period

1.3 years

First QC Date

August 28, 2015

Last Update Submit

March 7, 2017

Conditions

Gaucher Disease

Outcome Measures

Primary Outcomes (2)

  • - Assessment of PK parameter: Maximum plasma concentration observed (Cmax)

    3 days

  • - Assessment of PK parameter: Area under the plasma concentration (AUC)

    3 days

Secondary Outcomes (6)

  • Assessment of PK parameter: Area under the plasma concentration versus time curve (AUClast)

    3 days

  • Assessment of PK parameter: Apparent total body clearance (CL/F)

    3 days

  • Assessment of PK parameter: Apparent volume of distribution during the terminal phase (Vz/F)

    3 days

  • Assessment of PK parameter: Predicted accumulation ratio (Rac,pred)

    3 days

  • Assessment of PK parameter: Terminal half-life (t1/2z)

    3 days

  • +1 more secondary outcomes

Study Arms (4)

GZ385660 (healthy subjects)

EXPERIMENTAL

Single dose of eliglustat tartrate will be given under fed conditions

Drug: eliglustat

GZ385660 (subjects with mild renal impairment)

EXPERIMENTAL

Single dose of eliglustat tartrate will be given under fed conditions

Drug: eliglustat

GZ385660 (subjects with moderate renal impairment)

EXPERIMENTAL

Single dose of eliglustat tartrate will be given under fed conditions

Drug: eliglustat

GZ385660 (subjects with severe renal impairment)

EXPERIMENTAL

Single dose of eliglustat tartrate will be given under fed conditions

Drug: eliglustat

Interventions

eliglustatDRUG

Pharmaceutical form: capsule Route of administration: oral

Also known as: GZ385660
GZ385660 (healthy subjects)GZ385660 (subjects with mild renal impairment)GZ385660 (subjects with moderate renal impairment)GZ385660 (subjects with severe renal impairment)

Eligibility Criteria

Age18 Years - 79 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • 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.
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Investigational Site Number 840004

Miami, Florida, 33014, United States

Location

Investigational Site Number 840002

Saint Paul, Minnesota, 55144, United States

Location

Investigational Site Number 840001

Knoxville, Tennessee, 37920, United States

Location

MeSH Terms

Conditions

Gaucher Disease

Interventions

eliglustat

Condition Hierarchy (Ancestors)

SphingolipidosesLysosomal Storage Diseases, Nervous SystemBrain Diseases, Metabolic, InbornBrain Diseases, MetabolicBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMetabolism, Inborn ErrorsGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesLipidosesLipid Metabolism, Inborn ErrorsLysosomal Storage DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesLipid Metabolism Disorders

Study Officials

  • Clinical Sciences & Operations

    Sanofi

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

August 28, 2015

First Posted

September 1, 2015

Study Start

September 1, 2015

Primary Completion

January 1, 2017

Study Completion

January 1, 2017

Last Updated

March 8, 2017

Record last verified: 2017-03

Locations

US(3)