- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02536911
A Study of the Effects of Hepatic Impairment on the Pharmacokinetics and Tolerability of Eliglustat Tartrate
An Open-label Pharmacokinetic and Tolerability Study of Eliglustat Tartrate Given as a Single Dose in Subjects With Mild and Moderate Hepatic Impairment, and in Matched Subjects With Normal Hepatic Function
Primary Objective:
To study the effect of mild and moderate hepatic 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 and moderate hepatic impairment in comparison with matched subjects with normal hepatic function.
Studieoversigt
Detaljeret beskrivelse
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 1
Kontakter og lokationer
Studiesteder
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Florida
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Miami, Florida, Forenede Stater, 33014
- Investigational Site Number 840002
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Tennessee
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Knoxville, Tennessee, Forenede Stater, 37920
- Investigational Site Number 840001
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion criteria :
For subjects with hepatic impairment:
- Male or female subjects, between 18 and 79 years of age, inclusive.
- Body weight between 50.0 and 125.0 kg, inclusive if male, and between 40.0 and 110.0 kg, inclusive if female, body mass index (BMI) between 18.0 and 37 kg/m^2, inclusive.
- Stable chronic liver disease assessed by medical history, physical examination, laboratory values.
- For moderate hepatic impairment cohort: Child-Pugh total score ranging from 7 to 9, inclusive.
- For mild hepatic impairment cohort: Child-Pugh total score ranging from 5 to 6, inclusive.
For matched subjects:
- Male or female subjects, between 18 and 79 years of age, inclusive.
- Body weight within 15% of the body weight of the subjects with hepatic impairment and BMI between 18.0 and 37 kg/m^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).
Exclusion criteria:
For subjects with hepatic impairment:
- Uncontrolled clinically relevant cardiovascular, pulmonary, gastrointestinal, metabolic, hematological, neurological, psychiatric, systemic, ocular, gynecologic (if female), or infectious disease, or signs of acute illness.
- Hepatocarcinoma.
- Acute hepatitis.
- Hepatic encephalopathy grade 2, 3, and 4.
- Presence or history of drug hypersensitivity, or allergic disease, including active seasonal rhinitis, diagnosed and treated by a physician.
- History or presence of drug or alcohol abuse (alcohol consumption more than 40 g per day) within 2 years before inclusion.
- 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 inhibitors and/or inducers.
- 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 subjects:
- 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), breastfeeding.
- For subjects 50 years of age and younger: 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 the 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) given within 4 months before inclusion.
- For subjects older than 50 years of age: any significant change in chronic treatment medication within 14 days before inclusion.
- P-gp inhibitors and/or inducers, CYP2D6 and/or CYP3A inhibitors and/or inducers.
- Positive result on any of the following tests: hepatitis B surface antigen (HBs Ag), anti-hepatitis C virus (anti-HCV) antibodies, anti-HIV1 and anti-HIV2 Ab.
- History or presence of drug or alcohol abuse (alcohol consumption more than 40 g per day) within 2 years before inclusion.
- 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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: GZ385660 (sunde emner)
Enkeltdosis eliglustattartrat vil blive givet under foderforhold
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Lægemiddelform: kapsel Indgivelsesvej: oral
Andre navne:
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Eksperimentel: GZ385660 (subjects with mild hepatic impairment)
Single dose of eliglustat tartrate will be given under fed conditions
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Lægemiddelform: kapsel Indgivelsesvej: oral
Andre navne:
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Eksperimentel: GZ385660 (subjects with moderate hepatic impairment)
Single dose of eliglustat tartrate will be given under fed conditions
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Lægemiddelform: kapsel Indgivelsesvej: oral
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
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Assessment of PK parameter: Maximum plasma concentration observed (Cmax)
Tidsramme: 3 days
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3 days
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Assessment of PK parameter: Area under the plasma concentration (AUC)
Tidsramme: 3 days
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3 days
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Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
Vurdering af PK-parameter: Areal under plasmakoncentrationen versus tidskurven (AUClast)
Tidsramme: Tre dage
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Tre dage
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Vurdering af PK-parameter: Tilsyneladende total kropsclearance (CL/F)
Tidsramme: Tre dage
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Tre dage
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Vurdering af PK-parameter: Tilsyneladende distributionsvolumen under terminalfasen (Vz/F)
Tidsramme: Tre dage
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Tre dage
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Vurdering af PK-parameter: Forudsagt akkumuleringsforhold (Rac,pred)
Tidsramme: Tre dage
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Tre dage
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Vurdering af PK-parameter: Terminal halveringstid (t1/2z)
Tidsramme: Tre dage
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Tre dage
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Antal uønskede hændelser
Tidsramme: Op til 10 dage
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Op til 10 dage
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Change from baseline in ECG parameter
Tidsramme: Baseline, Up to 10 days
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Baseline, Up to 10 days
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Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Metaboliske sygdomme
- Hjernesygdomme
- Sygdomme i centralnervesystemet
- Sygdomme i nervesystemet
- Genetiske sygdomme, medfødte
- Metabolisme, medfødte fejl
- Lysosomale opbevaringssygdomme
- Lipidmetabolismeforstyrrelser
- Hjernesygdomme, metaboliske
- Hjernesygdomme, metaboliske, medfødte
- Sphingolipidoser
- Lysosomale opbevaringssygdomme, nervesystemet
- Lipidoser
- Lipidmetabolisme, medfødte fejl
- Gauchers sygdom
- Molekylære mekanismer for farmakologisk virkning
- Enzymhæmmere
- Eliglustat
Andre undersøgelses-id-numre
- POP13777
- U1111-1170-3678 (Anden identifikator: UTN)
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med eliglustat
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Genzyme, a Sanofi CompanyAfsluttet
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Genzyme, a Sanofi CompanyAfsluttetGauchers sygdomCanada, Den Russiske Føderation, Tunesien
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Genzyme, a Sanofi CompanyAfsluttetGauchers sygdomForenede Stater, Sverige, Indien, Holland, Østrig, Japan, Kina, Serbien, Frankrig, Kroatien, Australien, Portugal, Canada, Brasilien, Grækenland, Rumænien, Den Russiske Føderation
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SanofiAfsluttetGauchers sygdomForenede Stater
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Genzyme, a Sanofi CompanyAfsluttetGauchers sygdomForenede Stater
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Genzyme, a Sanofi CompanyAfsluttetGauchers sygdom, type 1Forenede Stater, Det Forenede Kongerige, Bulgarien, Canada, Colombia, Indien, Israel, Libanon, Mexico, Den Russiske Føderation, Serbien, Tunesien
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Genzyme, a Sanofi CompanyAfsluttetGauchers sygdom, type 1Forenede Stater, Frankrig, Tyskland, Italien, Brasilien, Australien, Argentina, Canada, Egypten, Den Russiske Føderation, Spanien, Det Forenede Kongerige
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SanofiAfsluttet