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Completed

NCT Number: NCT02116543

TD-6450 MAD Study in HCV Infected Subjects

This proof of concept study is designed to evaluate the safety, tolerability, pharmacokinetics, and antiviral activity of TD-6450 in treatment naïve subjects with GT-1, GT-2 or GT-3 chronic HCV.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Texas Liver Institute

San Antonio, Texas, 78215, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Subject is HCV antibody positive
  • Subject is treatment naïve, with no history of exposure (single or multiple dose) to interferon, ribavirin or direct acting antivirals.
  • Subject has had a liver biopsy within 3 years or Fibroscan evaluation within 6 months prior to Screening that clearly excludes cirrhosis. If not available prior to Screening, the absence of cirrhosis must be confirmed prior to subject enrollment using either Fibroscan or Fibrosure®.
  • Subject is negative for hepatitis A (HAV), hepatitis B (HBV), and human immunodeficiency virus (HIV).

Exclusion criteria

  • Subject has prior histological evidence of cirrhosis or current clinical evidence of cirrhosis in the opinion of the investigator.
  • Subject has a history or evidence of non-hepatitis C chronic liver disease.
  • Subject has an estimated creatinine clearance of <80 ml/min if 18-60 years of age, inclusive; or <70 ml/min if >60 years of age, calculated using the Cockcroft-Gault equation.

Treatment and study plan

TD-6450

Drug

Placebo

Drug

Primary outcomes

  1. Adverse events

    Time frame: 28 Days

    Number, type, severity, and association of treatment emergent adverse events.

Secondary outcomes

  1. Cmax

    Time frame: 28 Days

    Cmax

  2. Tmax

    Time frame: 28 Days

    Tmax

  3. AUC0-t

    Time frame: 28 Days

  4. AUC0-∞

    Time frame: 28 Days

    AUC0-∞

  5. AUC0-24

    Time frame: 28 Days

  6. Antiviral Activity

    Time frame: 28 Days

    Change from baseline in HCV RNA

  7. t1/2

    Time frame: 28 Days

    t1/2

Sponsors and collaborators

Lead sponsor

Theravance Biopharma

Industry

Registry information

Official study title

A Double-Blinded, Randomized, Placebo-Controlled, Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetic, and Antiviral Activity of TD-6450, a NS5A Inhibitor, in Treatment Naïve Subjects With Genotype 1, 2 or 3 Chronic Hepatitis C Virus (HCV)

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Apr 17, 2014
Registry last updated
Jan 19, 2021

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.

Published trials that share one or more normalized conditions with this study.