Study in HCV-Infected Patients to Determine the Safety, Tolerability, Pharmacokinetics and Antiviral Activity of JNJ-47910382
9 maj 2014 uppdaterad av: Janssen R&D Ireland
A Phase Ib, Randomized, Double-Blind, Placebo-Controlled Trial in Caucasian Genotype 1 Chronic HCV-Infected Subjects to Determine the Safety, Tolerability, Pharmacokinetics and Antiviral Activity of Repeated Doses of JNJ-47910382 Given in Different Doses and Dose Regimens
The purpose of this study is to determine the safety, tolerability, pharmacokinetics (what the body does to the medication) and antiviral activity of JNJ-47910382 when administered in different dosing regimens in Caucasian genotype-1 chronic HCV-infected patients.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
This is a Phase Ib, double-blind (neither physician nor patient knows the treatment that the patient receives), randomized (the study drug is assigned by chance), placebo-controlled study in treatment-naïve (someone who has never used drugs for HCV infection), Caucasian genotype 1 chronic HCV-infected patients.
The study consists of a screening period, a 9-day treatment period (with 5 days of actual medication intake) and a 4-week follow-up period.
The patients will be divided over 4 panels of 10 patients each that will be initiated sequentially.
In each panel patients will receive JNJ-47910382 or placebo during 5 consecutive days.
JNJ-47910382 or placebo will be administered once daily or twice daily.
Within each panel, 5 patients of genotype-1a and 5 patients of genotype-1b will be enrolled.
Patients will be randomly assigned to receive active treatment or placebo in such a way that 4 patients of each genotype receive active treatment and 1 subject of each genotype receives placebo.
The pharmacokinetic profile of JNJ-47910382 will be assessed in each panel.
HCV RNA kinetics (HCV RNA level) and HCV resistance will be studied and biomarkers at the messenger RNA (mRNA), protein and cell level will be explored.
The entire study duration for each participant will be approximately four weeks.
Studietyp
Interventionell
Inskrivning (Faktisk)
11
Fas
- Fas 1
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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-
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Hamburg, Tyskland
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Kiel, Tyskland
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Mainz, Tyskland
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Münster, Tyskland
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Tübingen, Tyskland
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Ulm, Tyskland
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-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år till 70 år (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
Inclusion Criteria:
- Chronic (diagnosis of hepatitis C more than or 6 months before the screening period) HCV infection. Geno- and subtype should be determined or confirmed at screening, and should be 1a or 1b
- Never received (Peg) IFN, RBV or any other approved or investigational antiviral treatment for chronic HCV infection
- HCV RNA level of >100,000 IU/mL at screening (as assessed by standard quantitative in vitro nucleic acid amplification assay)
- Patients having good accessible veins
Exclusion Criteria:
- Evidence of liver cirrhosis or decompensated liver disease
- Patient coinfected with HIV-1 or HIV-2, or hepatitis A or B virus infection, or active tuberculosis at study screening
- Patient infected/coinfected with non-genotype-1 HCV at study screening
- Patient with any cardiac disease at screening, or any active clinically significant disease, or medical history or physical examination findings during screening
- Patient having uncontrolled/unstable disease such as diabetes, epilepsy, a manifest psychiatric disease, thyroid disease or disorders
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Fyrdubbla
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Panel I
Patients will be randomized to receive JNJ-47910382 at a dose of 30 mg or placebo as monotherapy once daily for 5 days.
|
Form=suspension, route=oral.
Type=exact number, unit=mg, number=30, 90, 300, 400 or 450, form=suspension, route=oral.
Study drug will be administered once or twice daily
|
|
Experimentell: Panel II
Patients will be randomized to receive JNJ-47910382 at a dose of 90 mg or placebo as monotherapy once daily for 5 days.
|
Form=suspension, route=oral.
Type=exact number, unit=mg, number=30, 90, 300, 400 or 450, form=suspension, route=oral.
Study drug will be administered once or twice daily
|
|
Experimentell: Panel III
Patients will be randomized to receive JNJ-47910382 at a dose of 300 mg or placebo as monotherapy once daily for 5 days.
|
Form=suspension, route=oral.
Type=exact number, unit=mg, number=30, 90, 300, 400 or 450, form=suspension, route=oral.
Study drug will be administered once or twice daily
|
|
Experimentell: Panel IV
Patients will be randomized to receive JNJ-47910382 at a dose of 400 or 450 mg once daily or 300 mg twice daily (morning dose only on Day 5) or placebo as monotherapy for 5 days.
|
Form=suspension, route=oral.
Type=exact number, unit=mg, number=30, 90, 300, 400 or 450, form=suspension, route=oral.
Study drug will be administered once or twice daily
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Determination of pharmacokinetics of JNJ-47910382
Tidsram: Up to 9 Days
|
The pharmacokinetics of JNJ-47910382 after 5 consecutive days of administration in chronic HCV-genotype-1 infected patients in different doses and dose regimens will be determined.
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Up to 9 Days
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Evaluation of the intrinsic antiviral activity of JNJ-47910382
Tidsram: Up to 4 weeks
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Evaluation of the intrinsic antiviral activity of different doses and dose regimens of JNJ-47910382 in chronic HCV-genotype-1 infected subjects, as measured by the HCV RNA decrease from baseline (Day 1) over time.
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Up to 4 weeks
|
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Number of participants with adverse events as a measure of safety and tolerability
Tidsram: Up to 4 weeks
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Up to 4 weeks
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 augusti 2012
Primärt slutförande (Faktisk)
1 juni 2013
Avslutad studie (Faktisk)
1 juni 2013
Studieregistreringsdatum
Först inskickad
25 juli 2012
Först inskickad som uppfyllde QC-kriterierna
25 juli 2012
Första postat (Uppskatta)
27 juli 2012
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
12 maj 2014
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
9 maj 2014
Senast verifierad
1 maj 2014
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- CR100760
- 47910382HPC1002 (Annan identifierare: Janssen R&D Ireland)
- 2011-005110-10 (EudraCT-nummer)
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .