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

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.

Sponsoren

Hauptsponsor: Tibotec Pharmaceuticals, Ireland

Quelle Tibotec Pharmaceuticals, Ireland
Kurze Zusammenfassung

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.

detaillierte Beschreibung

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.

Gesamtstatus Completed
Anfangsdatum March 2009
Fertigstellungstermin November 2009
Primäres Abschlussdatum November 2009
Phase Phase 2
Studientyp Interventional
Primärer Ausgang
Messen Zeitfenster
Change From Baseline in log10 Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels Baseline, Day 3, and Day 7
Sekundäres Ergebnis
Messen Zeitfenster
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 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 Baseline, Day 3, Day 5 and Day 7
Number of Participants Who Experienced Viral Breakthrough During TMC435 Treatment Period During the 7-day of TMC435 treatment period
Predose Plasma Concentration (C0h) of TMC435 Predose on Day 7
Minimum Plasma Concentration (Cmin) of TMC435 Predose, and at 0.5, 1, 2, 4, 6, 8, and 10 hours post-dose on Day 7
Maximum Plasma Concentration (Cmax) of TMC435 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 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 Predose, and at 0.5, 1, 2, 4, 6, 8, and 10 hours post-dose on Day 7
Fluctuation Index (FI) of TMC435 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 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 Predose, and at 0.5, 1, 2, 4, 6, 8, and 10 hours post-dose on Day 7
Elimination Rate Constant of TMC435 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 Predose, and at 0.5, 1, 2, 4, 6, 8, and 10 hours post-dose on Day 7
Einschreibung 37
Bedingung
Intervention

Interventionsart: Drug

Interventionsname: TMC435

Beschreibung: From Day 1 to Day 7 all participants will take 200 mg TMC435350 as a single medication orally (by mouth) once daily.

Teilnahmeberechtigung

Kriterien:

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

Geschlecht: All

Mindestalter: 18 Years

Maximales Alter: 70 Years

Gesunde Freiwillige: No

Insgesamt offiziell
Nachname Rolle Zugehörigkeit
Tibotec Pharmaceuticals, Ireland Clinical Trial Study Director Tibotec Pharmaceuticals, Ireland
Ort
Einrichtung:
| Brugge, Belgium
| Brussels, Belgium
| Bruxelles, Belgium
| Gent, Belgium
| Leuven, Belgium
| Berlin, Germany
| Frankfurt N/A, Germany
| Freiburg, Germany
| Hannover, Germany
| Bangkok, Thailand
| Chiang Mai, Thailand
Standort Länder

Belgium

Germany

Thailand

Überprüfungsdatum

July 2014

Verantwortliche Partei

Art: Sponsor

Schlüsselwörter
Hat den Zugriff erweitert No
Bedingung Durchsuchen
Anzahl der Waffen 5
Armgruppe

Etikette: Genotype 2

Art: Experimental

Beschreibung: Participants with chronic genotype 2 hepatitis C virus (HCV) infection

Etikette: Genotype 3

Art: Experimental

Beschreibung: Participants with chronic genotype 3 HCV infection

Etikette: Genotype 4

Art: Experimental

Beschreibung: Participants with chronic genotype 4 HCV infection

Etikette: Genotype 5

Art: Experimental

Beschreibung: Participants with chronic genotype 5 HCV infection

Etikette: Genotype 6

Art: Experimental

Beschreibung: Participants with chronic genotype 6 HCV infection

Studiendesign Info

Zuweisung: Non-Randomized

Interventionsmodell: Parallel Assignment

Hauptzweck: Treatment

Maskierung: None (Open Label)

Quelle: ClinicalTrials.gov