- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01714154
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
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
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 1
Kontakter og lokationer
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
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
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Tildeling: Ikke-randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: A: setrobuvir
|
200 mg orally every 12 hours
|
Eksperimentel: B: setrobuvir + DNV/r
|
200 mg orally every 12 hours
100 mg orally every 12 hours
100 mg orally every 12 hours
|
Hvad måler undersøgelsen?
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
|
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 (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- NP28326
- 2012-002283-28 (EudraCT nummer)
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Kliniske forsøg med setrobuvir
-
Hoffmann-La RocheAfsluttet
-
Hoffmann-La RocheAfsluttet