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)

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02116543

Enrollment

Registered

2014-04-17

Start date

2014-05-31

Completion date

2014-11-30

Last updated

2021-01-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HCV, Hepatitis C

Keywords

Hepatitis C, HCV

Brief summary

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.

Interventions

DRUGTD-6450

DRUGPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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.

Design outcomes

Primary

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

Secondary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026