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- Sperimentazione clinica NCT00812331
A Study to Assess the Anti-viral Activity, Safety, Tolerability and Pharmacokinetics of TMC435350 in Participants Infected With Hepatitis C-Virus (HCV)
1 luglio 2014 aggiornato da: 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.
Panoramica dello studio
Descrizione dettagliata
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.
Tipo di studio
Interventistico
Iscrizione (Effettivo)
37
Fase
- Fase 2
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
Da 18 anni a 70 anni (Adulto, Adulto più anziano)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Descrizione
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
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Non randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
---|---|
Sperimentale: Genotype 2
Participants with chronic genotype 2 hepatitis C virus (HCV) infection
|
From Day 1 to Day 7 all participants will take 200 mg TMC435350 as a single medication orally (by mouth) once daily.
|
Sperimentale: Genotype 3
Participants with chronic genotype 3 HCV infection
|
From Day 1 to Day 7 all participants will take 200 mg TMC435350 as a single medication orally (by mouth) once daily.
|
Sperimentale: Genotype 4
Participants with chronic genotype 4 HCV infection
|
From Day 1 to Day 7 all participants will take 200 mg TMC435350 as a single medication orally (by mouth) once daily.
|
Sperimentale: Genotype 5
Participants with chronic genotype 5 HCV infection
|
From Day 1 to Day 7 all participants will take 200 mg TMC435350 as a single medication orally (by mouth) once daily.
|
Sperimentale: Genotype 6
Participants with chronic genotype 6 HCV infection
|
From Day 1 to Day 7 all participants will take 200 mg TMC435350 as a single medication orally (by mouth) once daily.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Change From Baseline in log10 Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels
Lasso di tempo: 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
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio
1 marzo 2009
Completamento primario (Effettivo)
1 novembre 2009
Completamento dello studio (Effettivo)
1 novembre 2009
Date di iscrizione allo studio
Primo inviato
18 dicembre 2008
Primo inviato che soddisfa i criteri di controllo qualità
18 dicembre 2008
Primo Inserito (Stima)
22 dicembre 2008
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
28 luglio 2014
Ultimo aggiornamento inviato che soddisfa i criteri QC
1 luglio 2014
Ultimo verificato
1 luglio 2014
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
- Malattie dell'apparato digerente
- Infezioni da virus a RNA
- Malattie virali
- Infezioni
- Infezioni a trasmissione ematica
- Malattie trasmissibili
- Malattie del fegato
- Flaviviridae Infezioni
- Epatite, virale, umana
- Infezioni da enterovirus
- Infezioni da Picornaviridae
- Epatite
- Epatite A
- Epatite C
- Meccanismi molecolari dell'azione farmacologica
- Agenti antinfettivi
- Agenti antivirali
- Inibitori enzimatici
- Inibitori della proteasi
- Simprevir
Altri numeri di identificazione dello studio
- CR012604
- TMC435350-TiDP16-C202 (Altro identificatore: Tibotec Pharmaceuticals, Ireland)
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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