Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

A Safety And Pharmacokinetic Study of Setrobuvir Alone and In Combination With Ritonavir-Boosted Danoprevir in Subjects With Mild Hepatic Impairment Compared to Healthy Controls

1. november 2016 oppdatert av: Hoffmann-La Roche

A Multi Center, Sequential, Open-Label, Multiple-Dose Study of Setrobuvir (STV) Alone and With Co-Administration of Ritonavir-boosted Danoprevir to Evaluate the Safety, Tolerability and Pharmacokinetics of STV, DNV, and Ritonavir (RTV) in Subjects With Mild Hepatic Impairment Compared to Healthy Controls

This multi-center, fixed-sequence, open-label, multiple-dose, 2-period study will evaluate the safety, tolerability and pharmacokinetics of setrobuvir alone or in combination with ritonavir-boosted danoprevir in subjects with mild hepatic impairment compared to healthy controls. All subjects will receive multiple doses of setrobuvir orally for 10 days in Period 1 and multiple doses of setrobuvir plus ritonavir-boosted danoprevir orally for 10 days in Period 2, with a washout phase of at least 9 days between treatments.

Studieoversikt

Studietype

Intervensjonell

Registrering (Faktiske)

18

Fase

  • Fase 1

Kontakter og plasseringer

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

Studiesteder

      • Warszawa, Polen, 01-201
      • Balatonfuered, Ungarn, 8230
      • Budapest, Ungarn, 1076

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

Ja

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • Male and female adults, 18-65 years of age, inclusive
  • Weight >/= 45.0 kg
  • Body mass index (BMI) 18.0 - 35.0 kg/m2, inclusive
  • Females of childbearing potential and males and their female partners of childbearing potential must agree to use two forms of non-hormonal contraception as defined by protocol
  • Subjects with a history of substance abuse may be enrolled provided they have not abused drugs or alcohol for at least 6 months
  • Healthy subjects only:

Medical history without major recent or ongoing pathology Laboratory values at screening and Day -1 within the normal range or showing no clinically relevant deviations

  • Subjects with hepatic impairment only:

Stable mild liver disease (Child-Pugh A) of cryptogenic, post-hepatic, hepatitis B/C, or alcoholic origin Stable hepatic impairment defined as no clinically significant change in disease status within the last 30 days Must be on stable dose of medication and/or treatment regimen at least 2 weeks before dosing of study medication

Exclusion Criteria:

  • Pregnant or lactating women or males with female partners who are pregnant or lactating
  • Active infection or febrile illness </= 10 days prior to the first dose of study medication
  • Uncontrolled/untreated hypertension
  • Inadequate renal function
  • Positive urine drug screen or positive breath alcohol test at screening and on Day -1 of each period
  • An average alcohol intake of more than 2 units per day or 14 units per week until 48 hours prior to enrollment
  • History of any significant drug-related allergy or hepatotoxicity
  • Participation in other clinical studies with an investigational drug or new chemical entity within 3 months (6 months for biologic therapies) prior to the first dose of study medication
  • Positive for HIV infection
  • Any clinically significant cardiovascular or cerebrovascular disease
  • Healthy subjects only:

Any clinically significant concomitant disease or condition that could interfere with, or for which the treatment might interfere with, the conduct of the study, absorption of medication, or that would, in the opinion of the investigator, pose an unacceptable risk to the subject in this study Positive screening test for HBsAg or HCV antibody

  • Subjects with hepatic impairment only:

Severe ascites at screening or Day -1 History of or current severe hepatic encephalopathy (Grade 3 or higher) Biliary liver cirrhosis or other causes of hepatic impairment not related to parenchymal disorder and/or disease of the liver Positive screening test for HCV antigen

Studieplan

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

Hvordan er studiet utformet?

Designdetaljer

  • Tildeling: Ikke-randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: A: setrobuvir
200 mg orally every 12 hours
Eksperimentell: B: setrobuvir + DNV/r
200 mg orally every 12 hours
100 mg orally every 12 hours
100 mg orally every 12 hours

Hva måler studien?

Primære resultatmål

Resultatmål
Tidsramme
Safety: Incidence of adverse events
Tidsramme: approximately 40 days
approximately 40 days
Pharmacokinetics: Maximum plasma concentration at steady-state (Css,max)
Tidsramme: up to 16 days
up to 16 days
Pharmacokinetics: Total area under the concentration-time curve form time 0 to 12 hours post-dose at steady-state (AUCss,0-12h)
Tidsramme: up to 16 days
up to 16 days
Pharmacokinetics: Plasma concentration at steady-state 12 hours post-dose (Css, 12h)
Tidsramme: up to 16 days
up to 16 days

Sekundære resultatmål

Resultatmål
Tidsramme
Pharmacokinetics: Time to maximum plasma concentration (tmax)
Tidsramme: up to 16 days
up to 16 days
Pharmacokinetics: Elimination half-life (t1/2)
Tidsramme: up to 16 days
up to 16 days
Pharmacokinetics: Apparent oral clearance at steady-state (CLss/F)
Tidsramme: up to 16 days
up to 16 days
Pharmacokinetics: Cumulative amount excreted at steady-state (Aess)
Tidsramme: up to 16 days
up to 16 days
Pharmacokinetics: Fraction of orally administered drug excreted into urine (fe/f)
Tidsramme: up to 16 days
up to 16 days
Pharmacokinetics of danoprevir in combination with setrobuvir: Area under the concentration-time curve (AUC)
Tidsramme: up to 12 days
up to 12 days
Pharmacokinetics of ritonavir in combination with setrobuvir: Area under the concentration-time curve (AUC)
Tidsramme: up to 12 days
up to 12 days

Samarbeidspartnere og etterforskere

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

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. november 2012

Primær fullføring (Faktiske)

1. mai 2013

Studiet fullført (Faktiske)

1. mai 2013

Datoer for studieregistrering

Først innsendt

23. oktober 2012

Først innsendt som oppfylte QC-kriteriene

23. oktober 2012

Først lagt ut (Anslag)

25. oktober 2012

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

2. november 2016

Siste oppdatering sendt inn som oppfylte QC-kriteriene

1. november 2016

Sist bekreftet

1. november 2016

Mer informasjon

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Abonnere