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- Klinische proef 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
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Studietype
Inschrijving (Werkelijk)
Fase
- Fase 1
Contacten en locaties
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Toewijzing: Niet-gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
---|---|
Experimenteel: A: setrobuvir
|
200 mg orally every 12 hours
|
Experimenteel: B: setrobuvir + DNV/r
|
200 mg orally every 12 hours
100 mg orally every 12 hours
100 mg orally every 12 hours
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
---|---|
Safety: Incidence of adverse events
Tijdsspanne: approximately 40 days
|
approximately 40 days
|
Pharmacokinetics: Maximum plasma concentration at steady-state (Css,max)
Tijdsspanne: 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)
Tijdsspanne: up to 16 days
|
up to 16 days
|
Pharmacokinetics: Plasma concentration at steady-state 12 hours post-dose (Css, 12h)
Tijdsspanne: up to 16 days
|
up to 16 days
|
Secundaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
---|---|
Pharmacokinetics: Time to maximum plasma concentration (tmax)
Tijdsspanne: up to 16 days
|
up to 16 days
|
Pharmacokinetics: Elimination half-life (t1/2)
Tijdsspanne: up to 16 days
|
up to 16 days
|
Pharmacokinetics: Apparent oral clearance at steady-state (CLss/F)
Tijdsspanne: up to 16 days
|
up to 16 days
|
Pharmacokinetics: Cumulative amount excreted at steady-state (Aess)
Tijdsspanne: up to 16 days
|
up to 16 days
|
Pharmacokinetics: Fraction of orally administered drug excreted into urine (fe/f)
Tijdsspanne: up to 16 days
|
up to 16 days
|
Pharmacokinetics of danoprevir in combination with setrobuvir: Area under the concentration-time curve (AUC)
Tijdsspanne: up to 12 days
|
up to 12 days
|
Pharmacokinetics of ritonavir in combination with setrobuvir: Area under the concentration-time curve (AUC)
Tijdsspanne: up to 12 days
|
up to 12 days
|
Medewerkers en onderzoekers
Sponsor
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- NP28326
- 2012-002283-28 (EudraCT-nummer)
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