TD-6450 MAD Study in HCV Infected Subjects

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)

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.

Study Overview

• Status: Completed
• Conditions: Hepatitis C; HCV
• Intervention / Treatment: Drug: Placebo; Drug: TD-6450

• Study Type: Interventional
• Enrollment (Actual): 47
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Texas
    • San Antonio, Texas, United States, 78215
      • Texas Liver Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Placebo; Placebo capsules	Drug: Placebo
EXPERIMENTAL: TD-6450; TD-6450 capsules	Drug: TD-6450

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events	Number, type, severity, and association of treatment emergent adverse events.	28 Days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cmax	Cmax	28 Days
Tmax	Tmax	28 Days
AUC0-t		28 Days
AUC0-∞	AUC0-∞	28 Days
AUC0-24		28 Days
Antiviral Activity	Change from baseline in HCV RNA	28 Days
t1/2	t1/2	28 Days

Collaborators and Investigators

• Sponsor: Theravance Biopharma

Study record dates

Study Major Dates

• Study Start: May 1, 2014
• Primary Completion (ACTUAL): October 1, 2014
• Study Completion (ACTUAL): November 1, 2014

Study Registration Dates

• First Submitted: April 15, 2014
• First Submitted That Met QC Criteria: April 15, 2014
• First Posted (ESTIMATE): April 17, 2014

Study Record Updates

• Last Update Posted (ACTUAL): January 19, 2021
• Last Update Submitted That Met QC Criteria: January 15, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: HCV; Hepatitis C
• Additional Relevant MeSH Terms: Digestive System Diseases; RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Liver Diseases; Flaviviridae Infections; Hepatitis, Viral, Human; Enterovirus Infections; Picornaviridae Infections; Hepatitis; Hepatitis A; Hepatitis C
• Other Study ID Numbers: 0110