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A Study to Assess the Anti-viral Activity, Safety, Tolerability and Pharmacokinetics of TMC435350 in Participants Infected With Hepatitis C-Virus (HCV)

1 juli 2014 uppdaterad av: Tibotec Pharmaceuticals, Ireland

An Open-label Trial in Genotype 2, 3, 4, 5 and 6 Hepatitis C-infected Subjects to Evaluate the Antiviral Activity, Safety, Tolerability and Pharmacokinetics of TMC435350 Following 7 Days Once Daily Dosing as Monotherapy.

The purpose of this study is to assess anti-viral activity (inhibition of viral growth) of TMC435350 in genotype 2,3,4,5 and 6 hepatitis C virus infected participants who have never received treatment for their hepatitis C infection.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

This is an open-label (all people know the identity of the intervention) study to assess the antiviral activity, safety, tolerability and pharmacokinetics (explores what the body does to the medication) of TMC435350 hereafter referred to as TMC435. Approximately 40 participants will be divided in 5 groups as per the genotype (8 participants each group). The study will include a screening phase (up to 6 weeks), treatment phase (7 days) and a follow-up phase (30-35 days after the last dose of study medication). Safety evaluations will include assessment of adverse events, clinical laboratory tests and cardiovascular safety.

Studietyp

Interventionell

Inskrivning (Faktisk)

37

Fas

  • Fas 2

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Belgien
      • Brugge, Belgien
      • Brussels, Belgien
      • Bruxelles, Belgien
      • Gent, Belgien
      • Leuven, Belgien
  • Thailand
      • Bangkok, Thailand
      • Chiang Mai, Thailand
  • Tyskland
      • Berlin, Tyskland
      • Frankfurt N/A, Tyskland
      • Freiburg, Tyskland
      • Hannover, Tyskland

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:

  • Participants with documented chronic genotype 2, 3, 4, 5 or 6 hepatitis C virus (HCV) infection
  • Participants who have never received treatment for their HCV infection
  • Participants with either no cirrhosis or up to Child Pugh A liver disease
  • Participants with plasma HCV genotype level of more than or equal to 100, 000 IU/mL at screening

Exclusion Criteria:

  • Evidence of Child Pugh B or C liver disease at screening, decompensated liver disease defined as prior or current history of ascities, hepatic encephalopathy, esophageal or gastric varices
  • Participants with diagnosed or suspected hepatocellular carcinoma
  • Participants coinfected with human immunodeficiency virus type 1 or 2, or hepatitis A or B virus infection or active tuberculosis at screening
  • Participants with any active clinically significant disease, or medical history or physical examination or electrocardiogram findings during screening

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: Icke-randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Genotype 2
Participants with chronic genotype 2 hepatitis C virus (HCV) infection
Läkemedel: TMC435
From Day 1 to Day 7 all participants will take 200 mg TMC435350 as a single medication orally (by mouth) once daily.
Experimentell: Genotype 3
Participants with chronic genotype 3 HCV infection
Läkemedel: TMC435
From Day 1 to Day 7 all participants will take 200 mg TMC435350 as a single medication orally (by mouth) once daily.
Experimentell: Genotype 4
Participants with chronic genotype 4 HCV infection
Läkemedel: TMC435
From Day 1 to Day 7 all participants will take 200 mg TMC435350 as a single medication orally (by mouth) once daily.
Experimentell: Genotype 5
Participants with chronic genotype 5 HCV infection
Läkemedel: TMC435
From Day 1 to Day 7 all participants will take 200 mg TMC435350 as a single medication orally (by mouth) once daily.
Experimentell: Genotype 6
Participants with chronic genotype 6 HCV infection
Läkemedel: TMC435
From Day 1 to Day 7 all participants will take 200 mg TMC435350 as a single medication orally (by mouth) once daily.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change From Baseline in log10 Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels
Tidsram: Baseline, Day 3, and Day 7
The table below shows the mean changes from baseline in HCV RNA values (log10 IU/mL) per genotype on Day 3 and Day 7 during the TMC435 treatment period.
Baseline, Day 3, and Day 7

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Number of Participants With a Decrease From Baseline of Greater Than or Equal to 2 log10 IU/mL in Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) During the TMC435 Treatment Period
Tidsram: Baseline, Day 3, Day 5 and Day 7
The table below shows the number of participants with a decrease from baseline of greater than or equal to 2 log10 IU/mL in HCV RNA during the 7-day TMC435 treatment period.
Baseline, Day 3, Day 5 and Day 7
Number of Participants With Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels Below the Limit of Quantification (Less Than 25 IU/mL) and Limit of Detection (Less Than 25 IU/mL Undetectable) During the TMC435 Treatment Period
Tidsram: Baseline, Day 3, Day 5 and Day 7
The table below shows the number of participants with plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels below limit of quantification (less than 25 IU/mL) and limit of detection (less than 25 IU/mL undetectable), respectively, during the 7-day TMC435 treatment period.
Baseline, Day 3, Day 5 and Day 7
Number of Participants Who Experienced Viral Breakthrough During TMC435 Treatment Period
Tidsram: During the 7-day of TMC435 treatment period
The table below shows the number of participants who experienced viral breakthrough (defined as an increase greater than 1 log10 IU/mL in plasma level of hepatitis C virus [HCV] ribonucleic acid [RNA] from the lowest level reached, or a HCV RNA level greater than 100 IU/mL in participants who previously had HCV RNA levels undetectable [less than 25 IU/mL undetectable] or not quantifiable [less than 25 IU/mL detectable]) during the 7-day TMC435 treatment period.
During the 7-day of TMC435 treatment period
Predose Plasma Concentration (C0h) of TMC435
Tidsram: Predose on Day 7
The table below shows the median predose plasma concentration (C0h) for all participants on Day 7 of the TMC435 treatment period.
Predose on Day 7
Minimum Plasma Concentration (Cmin) of TMC435
Tidsram: Predose, and at 0.5, 1, 2, 4, 6, 8, and 10 hours post-dose on Day 7
The table below shows the median minimum plasma concentration (Cmin) for all participants on Day 7 of the TMC435 treatment period.
Predose, and at 0.5, 1, 2, 4, 6, 8, and 10 hours post-dose on Day 7
Maximum Plasma Concentration (Cmax) of TMC435
Tidsram: Predose, and at 0.5, 1, 2, 4, 6, 8, and 10 hours post-dose on Day 7
The table below shows the median maximum plasma concentration (Cmax) for all participants by genotype of hepatitis C virus infection on Day 7 of the TMC435 treatment period.
Predose, and at 0.5, 1, 2, 4, 6, 8, and 10 hours post-dose on Day 7
Time to Reach the Maximum Plasma Concentration (Tmax) of TMC435
Tidsram: Predose, and at 0.5, 1, 2, 4, 6, 8, and 10 hours post-dose on Day 7
The table below shows the median time in hours for all participants (by genotype of hepatitis C virus infection) to reach the maximum plasma concentration (tmax) of TMC435 following treatment.
Predose, and at 0.5, 1, 2, 4, 6, 8, and 10 hours post-dose on Day 7
Average Steady-State Plasma Concentration (Css,av) of TMC435
Tidsram: Predose, and at 0.5, 1, 2, 4, 6, 8, and 10 hours post-dose on Day 7
The table below shows the average steady-state TMC435 plasma concentration (Css,av) for all participants by genotype of hepatitis C virus infection on Day 7 during the TMC435 treatment period.
Predose, and at 0.5, 1, 2, 4, 6, 8, and 10 hours post-dose on Day 7
Fluctuation Index (FI) of TMC435
Tidsram: Predose, and at 0.5, 1, 2, 4, 6, 8, and 10 hours post-dose on Day 7
The table below shows the percentage of fluctuation (FI) (defined as the variation between maximum and minimum TMC435 plasma concentrations at steady-state) of TMC435 on Day 7 for participants by genotype of hepatitis C virus infection.
Predose, and at 0.5, 1, 2, 4, 6, 8, and 10 hours post-dose on Day 7
Area Under the Plasma Concentration-time Curve From the Time of Administration up to 24 Hours After Dosing (AUC24h) of TMC435
Tidsram: Predose, and at 0.5, 1, 2, 4, 6, 8, and 10 hours post-dose on Day 7
The table below shows the area under the plasma concentration-time curve from the time of administration up to 24 hours after dosing (AUC24h) of TMC435 on Day 7 for all participants by genotype of hepatitis C virus infection.
Predose, and at 0.5, 1, 2, 4, 6, 8, and 10 hours post-dose on Day 7
Area Under the Plasma Concentration-time Curve From Time of Administration up to the Last Time Point With a Measurable Concentration After Dosing (AUClast) of TMC435
Tidsram: Predose, and at 0.5, 1, 2, 4, 6, 8, and 10 hours post-dose on Day 7
The table below shows the area under the plasma concentration-time curve from time of administration up to the last time point with a measurable concentration after dosing (AUClast) on Day 7 for TMC435 by genotype of hepatitis C virus infection.
Predose, and at 0.5, 1, 2, 4, 6, 8, and 10 hours post-dose on Day 7
Elimination Rate Constant of TMC435
Tidsram: Predose, and at 0.5, 1, 2, 4, 6, 8, and 10 hours post-dose on Day 7
In the table below, median values for the elimination rate constant (the rate at which a drug is removed from the body expressed per unit of time, e.g., fraction/hour) for TMC435 are shown for participants by genotype of hepatitis C virus infection.
Predose, and at 0.5, 1, 2, 4, 6, 8, and 10 hours post-dose on Day 7
Terminal Elimination Half-life (t1/2,Term) of TMC435
Tidsram: Predose, and at 0.5, 1, 2, 4, 6, 8, and 10 hours post-dose on Day 7
The table below shows the terminal plasma half-life for TMC435 in participants analyzed by genotype of hepatitis C virus infection. The terminal plasma half-life of a drug is the time in hours required for the concentration of a drug in the body to fall to 50% after having reached a state of equilibrium following administration.
Predose, and at 0.5, 1, 2, 4, 6, 8, and 10 hours post-dose on Day 7

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Tibotec Pharmaceuticals, Ireland

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 mars 2009

Primärt slutförande (Faktisk)

1 november 2009

Avslutad studie (Faktisk)

1 november 2009

Studieregistreringsdatum

Först inskickad

18 december 2008

Först inskickad som uppfyllde QC-kriterierna

18 december 2008

Första postat (Uppskatta)

22 december 2008

Uppdateringar av studier

Senaste uppdatering publicerad (Uppskatta)

28 juli 2014

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

1 juli 2014

Senast verifierad

1 juli 2014

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • CR012604
  • TMC435350-TiDP16-C202 (Annan identifierare: Tibotec Pharmaceuticals, Ireland)

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 .

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