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Completed

NCT Number: NCT00812331

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

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.

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Key information

Conditions

Hepatitis C Blood-Borne Infections Communicable Diseases Digestive System Diseases Flaviviridae Infections Hepatitis Hepatitis, Viral, Human Infections Liver Diseases RNA Virus Infections Virus Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Bruges, Belgium

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TMC435

Drug

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

Primary outcomes

  1. Change From Baseline in log10 Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels

    Time frame: 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.

Secondary outcomes

  1. 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

    Time frame: 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.

  2. 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

    Time frame: 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.

  3. Number of Participants Who Experienced Viral Breakthrough During TMC435 Treatment Period

    Time frame: 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.

  4. Predose Plasma Concentration (C0h) of TMC435

    Time frame: 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.

  5. Minimum Plasma Concentration (Cmin) of TMC435

    Time frame: 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.

  6. Maximum Plasma Concentration (Cmax) of TMC435

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: 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.

  9. Fluctuation Index (FI) of TMC435

    Time frame: 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.

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

    Time frame: 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.

  11. 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

    Time frame: 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.

  12. Elimination Rate Constant of TMC435

    Time frame: 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.

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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Tibotec Pharmaceuticals, Ireland

Industry

Registry information

Official study 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.

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Dec 22, 2008
Registry last updated
Jul 28, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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