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

Condition(s) targeted: Hepatitis C

Intervention: TMC435 (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Tibotec Pharmaceuticals, Ireland

Official(s) and/or principal investigator(s):
Tibotec Pharmaceuticals, Ireland Clinical Trial, Study Director, Affiliation: Tibotec Pharmaceuticals, Ireland

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.

Official title: 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.

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Change From Baseline in log10 Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels

Secondary outcome:

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

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

Number of Participants Who Experienced Viral Breakthrough During TMC435 Treatment Period

Predose Plasma Concentration (C0h) of TMC435

Minimum Plasma Concentration (Cmin) of TMC435

Maximum Plasma Concentration (Cmax) of TMC435

Time to Reach the Maximum Plasma Concentration (Tmax) of TMC435

Average Steady-State Plasma Concentration (Css,av) of TMC435

Fluctuation Index (FI) of TMC435

Area Under the Plasma Concentration-time Curve From the Time of Administration up to 24 Hours After Dosing (AUC24h) of TMC435

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

Elimination Rate Constant of TMC435

Terminal Elimination Half-life (t1/2,Term) of TMC435

Detailed description: 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.

Minimum age: 18 Years. Maximum age: 70 Years. Gender(s): Both.

Criteria:

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

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

Starting date: March 2009
Last updated: July 1, 2014