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A Study of EDP-514 in Healthy Subjects (Part 1) and Patients With Chronic Hepatitis B Virus Infection (Part 2)

6. januar 2022 opdateret af: Enanta Pharmaceuticals, Inc

A Phase 1a/1b Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Doses of EDP 514 in Healthy Subjects (Part 1), and Antiviral Activity in Nucleos(t)Ide Reverse Transcriptase Inhibitor (NUC)-Suppressed Patients With Chronic Hepatitis B Virus Infection (Part 2)

Part 1 is a randomized, double-blind, placebo-controlled study. It will assess the safety, tolerability, and pharmacokinetics of single and multiple orally administered doses of EDP-514 in healthy adult subjects.

Part 2 is randomized, double -blind, placebo-controlled study including subjects with Hepatitis B Virus. It will assess the safety, tolerability, pharmacokinetics and antiviral activity of 28 Days of orally administered doses of EDP-514 in nucleos(t)ide reverse transcriptase inhibitor (NUC)-Suppressed Patients with Chronic Hepatitis B Virus Infection

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Part 1 consists of two phases planned in healthy subjects:

The first phase assesses single ascending doses for EDP-514 (active drug or placebo) in healthy subjects. A "fasted" and "fed" two-part cohort will also assess food effect.

The second phase assesses multiple ascending doses (active drug or placebo) for 14 days in healthy subjects.

Each cohort within each phase will enroll a total of 8 subjects who will be randomized to receive EDP-514 or placebo. The cohort assessing food effect will enroll 10 subjects randomized to receive EDP-514 or placebo.

Part 2 assesses multiple ascending doses EDP-514 (active drug or placebo) for 28 days in nucleos(t)ide reverse transcriptase inhibitor (NUC)-Suppressed Patients with Chronic Hepatitis B Virus Infection.

Each cohort in Part 2 will enroll a total of 8 subjects who will be randomized to receive EDP-514 or placebo.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

99

Fase

  • Fase 1

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 4Z6
        • University of Calgary
    • British Columbia
      • Vancouver, British Columbia, Canada, V6Z 2K5
        • Gastroenterology Institute of Research Institute
    • Ontario
      • Toronto, Ontario, Canada, M5G 2C4
        • Toronto General Hospital
    • Quebec
      • Montréal, Quebec, Canada, H2X 0A9
        • Centre Hospitalier de l'Universite de Montreal
  • Forenede Stater
    • California
      • Coronado, California, Forenede Stater, 92118
        • Southern California GI and Liver Centers
      • Los Angeles, California, Forenede Stater, 90095
        • University of California Los Angeles
      • San Diego, California, Forenede Stater, 92105
        • Tuan Nguyen Md Gastroenterology & Hepatology (Tuan Nguyen, M.D., Inc.)
      • San Francisco, California, Forenede Stater, 94115
        • Quest Clinical Research
    • Florida
      • Miami, Florida, Forenede Stater, 33136
        • University of Miami Miller School of Medicine
    • Kansas
      • Lenexa, Kansas, Forenede Stater, 66219
        • Pharmaceutical Research Associates, Inc.
    • Maryland
      • Catonsville, Maryland, Forenede Stater, 21228
        • Digestive Disease Associates - Catonsville
    • New York
      • New York, New York, Forenede Stater, 10029
        • Icahn School of Medicine at Mount Sinai
    • Texas
      • Houston, Texas, Forenede Stater, 77030
        • American Research Corporation
      • San Antonio, Texas, Forenede Stater, 78215
        • The Texas Liver Institute
    • Washington
      • Seattle, Washington, Forenede Stater, 98104
        • Swedish Organ Transplant and Liver Center

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 70 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Part 1 (HV Population):

Inclusion Criteria:

  • An informed consent document signed and dated by the subject.
  • Healthy male and female subjects of any ethnic origin between the ages of 18 and 65 years, inclusive.

Exclusion Criteria:

  • Clinically relevant evidence or history of illness or disease.
  • Pregnant or nursing females.
  • History of febrile illness within 7 days prior to the first dose of study drug or subjects with evidence of active infection.
  • A positive urine drug screen at screening or Day -1.
  • Current tobacco smokers or use of tobacco within 3 months prior to screening.
  • Any condition possibly affecting drug absorption (e.g., gastrectomy, cholecystectomy).
  • History of regular alcohol consumption.
  • Receipt of any vaccine, an investigational agent or biological product within 28 days or 5 times the t½, whichever one is longer, prior to first dose. This includes agents administered during clinical trial participation.

Part 2 (HBV Population):

Inclusion Criteria:

  • An informed consent document signed and dated by the subject.
  • Healthy male and female subjects of any ethnic origin between the ages of 18 and 70 years, inclusive

  • HBV DNA levels:

    • A Screening HBV DNA level in serum/plasma that is <LLOQ and
    • No HBV DNA serum/plasma test values ≥LLOQ over the previous 12 months (using an approved test)
  • CHB subjects must have been on their prescribed HBV NUC treatment with no change in regimen for 12 months prior to Screening

Exclusion Criteria:

  • A documented prior diagnosis of cirrhosis
  • Pregnant or nursing females
  • Coinfection with human immunodeficiency virus (HIV), HCV, HDV, HAV, or HEV
  • Chronic liver disease of a non-HBV etiology; coexisting liver or biliary diseases

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Sekventiel tildeling
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: EDP-514 HV SAD Cohorts
EDP-514 Dose 1, Dose 2, Dose 3, Dose 4, Dose 5 and Dose 6 orally, once daily in one single administration
Medicin: EDP-514
Oral Capsule; Subjects will receive either a single dose of EDP-514 on Day 1 only (SAD HV), once daily dosing of EDP-514 starting on Day 1 through Day 14 (MAD HV) or once daily dosing of EDP-514 starting on Day 1 through Day 28 (MAD HBV).
Eksperimentel: EDP-514 HV MAD Cohorts
EDP-514 Dose 1, Dose 2 and Dose 3 orally, once daily for 14 days
Medicin: EDP-514
Oral Capsule; Subjects will receive either a single dose of EDP-514 on Day 1 only (SAD HV), once daily dosing of EDP-514 starting on Day 1 through Day 14 (MAD HV) or once daily dosing of EDP-514 starting on Day 1 through Day 28 (MAD HBV).
Placebo komparator: EDP-514 HV SAD Placebo Cohort
Matching placebo, orally, once daily in one single administration
Medicin: Placebo
Placebo, der matcher EDP-514
Placebo komparator: EDP-514 HV MAD Placebo Cohort
Matching placebo, orally, once daily for 14 days
Medicin: Placebo
Placebo, der matcher EDP-514
Eksperimentel: EDP-514 HBV MAD Cohorts
EDP-514 Dose 1, Dose 2 and Dose 3 orally, once daily for 28 days
Medicin: EDP-514
Oral Capsule; Subjects will receive either a single dose of EDP-514 on Day 1 only (SAD HV), once daily dosing of EDP-514 starting on Day 1 through Day 14 (MAD HV) or once daily dosing of EDP-514 starting on Day 1 through Day 28 (MAD HBV).
Placebo komparator: EDP-514 HBV MAD Placebo Cohort
Matching placebo, orally, once daily for 28 days
Medicin: Placebo
Placebo, der matcher EDP-514

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Sikkerhed målt ved uønskede hændelser
Tidsramme: Op til 8 dage i HV SAD-kohorter
Op til 8 dage i HV SAD-kohorter
Sikkerhed målt ved uønskede hændelser
Tidsramme: Op til 21 dage i HV MAD-kohorter
Op til 21 dage i HV MAD-kohorter
Safety measured by adverse events
Tidsramme: Up to 56 Days in HBV MAD Cohorts
Up to 56 Days in HBV MAD Cohorts

Sekundære resultatmål

Resultatmål
Tidsramme
Cmax of EDP-514
Tidsramme: Up to 6 Days in HV SAD Cohorts
Up to 6 Days in HV SAD Cohorts
AUC of EDP-514
Tidsramme: Up to 6 Days in HV SAD Cohorts
Up to 6 Days in HV SAD Cohorts
Cmax of EDP-514
Tidsramme: Up to 18 Days in HV MAD Cohorts
Up to 18 Days in HV MAD Cohorts
AUC of EDP-514
Tidsramme: Up to 18 Days in HV MAD Cohorts
Up to 18 Days in HV MAD Cohorts
Cmax for EDP-514
Tidsramme: Op til 28 dage i HBV MAD-kohorter
Op til 28 dage i HBV MAD-kohorter
AUC for EDP-514
Tidsramme: Op til 28 dage i HBV MAD-kohorter
Op til 28 dage i HBV MAD-kohorter

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Enanta Pharmaceuticals, Inc

Samarbejdspartnere

Pharmaceutical Research Associates

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

26. juni 2019

Primær færdiggørelse (Faktiske)

14. juli 2021

Studieafslutning (Faktiske)

14. juli 2021

Datoer for studieregistrering

Først indsendt

2. juli 2019

Først indsendt, der opfyldte QC-kriterier

2. juli 2019

Først opslået (Faktiske)

5. juli 2019

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

11. januar 2022

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

6. januar 2022

Sidst verificeret

1. maj 2021

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • EDP 514-001

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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 Kronisk HBV-infektion

Kliniske forsøg med EDP-514

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Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Hong Kong

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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