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A Study Evaluating GS-9620 in Treatment Naive Subjects With Chronic Hepatitis C

12. august 2013 oppdatert av: Gilead Sciences

A Double-Blind, Randomized, Placebo-Controlled, Single and Multiple-Dose Ranging Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Antiviral Activity of GS-9620 in Treatment Naive Subjects With Chronic Hepatitis C Virus Infection

Dose cohorts may be dosed with one of up to 4 possible total weekly doses (0.3 mg, 1 mg, 2 mg, 4 mg). Dose escalation or repetition will be governed by pre-specified safety and activity rules. Subjects will be confined on either days 1-3 and/or days 8-10. Follow-up visits are also required periodically through day 43. Study procedures involve taking blood samples for pharmacokinetic, pharmacodynamic, virologic, and safety assessments.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

51

Fase

  • Fase 1

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Forente stater
    • Arkansas
      • Little Rock, Arkansas, Forente stater, 72211
        • Woodland International Research Group
    • Florida
      • DeLand, Florida, Forente stater, 32720
        • Avail Clinical Research, LLC
      • Orlando, Florida, Forente stater, 32809
        • Orlando Clinical Research Center
    • Missouri
      • Kansas City, Missouri, Forente stater, 64131
        • Kansas City Gastroenterology and Hepatology
    • New Jersey
      • Berlin, New Jersey, Forente stater, 08009
        • Comprehensive Clinical Research
      • Willingboro, New Jersey, Forente stater, 08046
        • CRI Worldwide, LLC
    • New York
      • New York, New York, Forente stater, 10019
        • Clinilabs
    • Pennsylvania
      • Philadelphia, Pennsylvania, Forente stater, 19139
        • CRI Worldwide, LLC
    • Texas
      • San Antonio, Texas, Forente stater, 78215
        • Alamo Medical Research
    • Utah
      • Salt Lake City, Utah, Forente stater, 84106
        • Lifetree Clinical Research
  • Puerto Rico
      • Santurce, Puerto Rico, 00909
        • Fundacion De Investigacion de Diego

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 65 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • Males and Females 18-65 years old
  • Chronic HCV infection for at least 6 months, treatment naive
  • HCV Viral load > 100,000 IU/mL at Screening
  • Monoinfection with HCV 1 genotype
  • Hepatitis B surface antigen negative
  • Screening ECG without clinically significant abnormalities
  • BMI 18-33 kg/m^2
  • Creatinine clearing > 70 mL/min
  • Negative pregnancy test at screening

Exclusion Criteria:

  • Pregnant or lactating subjects
  • Co-infection with hepatitis B virus (HBV) or HIV
  • History of Gilberts disease
  • Particular abnormal laboratory parameters
  • Diagnosis of autoimmune disease, poorly controlled diabetes, significant psychiatric illness, severe chronic obstructive pulmonary disease (COPD), malignancy, hemoglobinopathy, retinal disease, and those who are immunosuppressed
  • Evidence of hepatocellular carcinoma
  • On-going alcohol abuse
  • Positive uring drug screen

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Trippel

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 0,3 mg GS-9620
Legemiddel: Single Ascending Dose Cohorts GS-9620
This study will enroll cohorts of 6 eligible, unique subjects per cohort, randomized to either active drug or placebo (5:1) within each cohort. Dose cohorts may be dosed with one of up to 4 possible total weekly doses (0.3 mg, 1 mg, 2 mg, 4 mg). Subjects in Single Ascending Dose (SAD) Cohorts will receive a single dose of GS-9620.
Eksperimentell: 1mg GS-9620
Legemiddel: Single Ascending Dose Cohorts GS-9620
This study will enroll cohorts of 6 eligible, unique subjects per cohort, randomized to either active drug or placebo (5:1) within each cohort. Dose cohorts may be dosed with one of up to 4 possible total weekly doses (0.3 mg, 1 mg, 2 mg, 4 mg). Subjects in Single Ascending Dose (SAD) Cohorts will receive a single dose of GS-9620.
Eksperimentell: 2mg GS-9620
Legemiddel: Single Ascending Dose Cohorts GS-9620
This study will enroll cohorts of 6 eligible, unique subjects per cohort, randomized to either active drug or placebo (5:1) within each cohort. Dose cohorts may be dosed with one of up to 4 possible total weekly doses (0.3 mg, 1 mg, 2 mg, 4 mg). Subjects in Single Ascending Dose (SAD) Cohorts will receive a single dose of GS-9620.
Eksperimentell: 4mg GS-9620
Legemiddel: Single Ascending Dose Cohorts GS-9620
This study will enroll cohorts of 6 eligible, unique subjects per cohort, randomized to either active drug or placebo (5:1) within each cohort. Dose cohorts may be dosed with one of up to 4 possible total weekly doses (0.3 mg, 1 mg, 2 mg, 4 mg). Subjects in Single Ascending Dose (SAD) Cohorts will receive a single dose of GS-9620.
Eksperimentell: 0,3 mg GS-9620 QW x 2 doser
Legemiddel: Multiple Ascending Dose Cohorts GS-9620
This study will enroll cohorts of 6 eligible, unique subjects per cohort, randomized to either active drug or placebo (5:1) within each cohort. Subjects in Multiple Ascending Dose (MAD) Cohorts will receive GS-9620 once weekly for two weeks (QW x 2 doses).
Eksperimentell: 1mg GS-9620 QW x 2 doser
Legemiddel: Multiple Ascending Dose Cohorts GS-9620
This study will enroll cohorts of 6 eligible, unique subjects per cohort, randomized to either active drug or placebo (5:1) within each cohort. Subjects in Multiple Ascending Dose (MAD) Cohorts will receive GS-9620 once weekly for two weeks (QW x 2 doses).
Eksperimentell: 2mg GS-9620 QW x 2 doser
Legemiddel: Multiple Ascending Dose Cohorts GS-9620
This study will enroll cohorts of 6 eligible, unique subjects per cohort, randomized to either active drug or placebo (5:1) within each cohort. Subjects in Multiple Ascending Dose (MAD) Cohorts will receive GS-9620 once weekly for two weeks (QW x 2 doses).
Eksperimentell: 4mg GS-9620 QW x 2 doser
Legemiddel: Multiple Ascending Dose Cohorts GS-9620
This study will enroll cohorts of 6 eligible, unique subjects per cohort, randomized to either active drug or placebo (5:1) within each cohort. Subjects in Multiple Ascending Dose (MAD) Cohorts will receive GS-9620 once weekly for two weeks (QW x 2 doses).

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Incidence of adverse events in single and multiple doses of GS-9620
Tidsramme: Periodically Day 1 to 6 months
Assessments include adverse events, laboratory abnormalities, 12-lead ECG abnormalities and interval measurements, and vital sign measurements
Periodically Day 1 to 6 months

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Assessment of plasma drug concentrations of GS-9620 using non-compartmental methods
Tidsramme: Day 1 and Day 8

Single ascending dose (SAD) cohorts: serial blood samples will be collected on Day 1 at 0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 16, 24, 48, and 96 hours post-dose.

Multiple ascending dose (MAD) cohorts: serial blood samples will be collected on Day 8 at 0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 16, and 24 hours post-dose.
Day 1 and Day 8
Measurement of pharmacodynamic markers (cytokines and interferon-stimulated genes [ISGs])
Tidsramme: Days 1, 2, 3, 5, 8

SAD cohorts: Whole blood and serum for pharmacodynamic (PD) assessments (RNA and cytokine analysis) will be drawn on Day 1: Pre-dose and 8-hour Post-dose, Day 2, Day 3, Day 5, Day 8

MAD cohorts: Whole blood and serum for PD assessments (RNA and cytokine analysis) will be drawn on Day 1: Pre-dose and 8-hours Post-dose, Day 2, Day 3, Day 5, Day 8: Pre-dose and 8 hours Post-dose, Day 9, Day 10, Day 12, and Day 15
Days 1, 2, 3, 5, 8
Reduction of hepatitis C (HCV) RNA viral load from baseline
Tidsramme: Screening, Baseline, Day 8 or 15

SAD cohorts: HCV viral load will be drawn at Day 1: Pre-dose, Day 2, 3, 5, 8 and both Follow-up Visits.

MAD cohorts: HCV viral load will be drawn at Day 1: Pre-dose, Day 2, 3, 5, Day 8: Pre-dose, 9, 10, 15, and both Follow-Up Visits.
Screening, Baseline, Day 8 or 15

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Gilead Sciences

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. mars 2012

Primær fullføring (Faktiske)

1. desember 2012

Studiet fullført (Faktiske)

1. desember 2012

Datoer for studieregistrering

Først innsendt

23. mars 2012

Først innsendt som oppfylte QC-kriteriene

2. mai 2012

Først lagt ut (Anslag)

4. mai 2012

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

13. august 2013

Siste oppdatering sendt inn som oppfylte QC-kriteriene

12. august 2013

Sist bekreftet

1. august 2013

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • GS-US-243-0102

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