TD-6450 MAD Study in HCV Infected Subjects

Phase 1

Completed

• Conditions: HCV; Hepatitis C
• Interventions: Drug: Placebo; Drug: TD-6450

• Registration Number: NCT02116543
• Lead Sponsor: Theravance Biopharma

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-04-15
• Study First Submitted QC: 2014-04-15
• Study First Posted: 2014-04-17
• Study Start: 2014-05
• Primary Completion: 2014-10
• Study Completion: 2014-11
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-15
• Last Update Posted: 2021-01-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 47

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo capsules
TD-6450	TD-6450	TD-6450 capsules

Primary Outcome Measures

Name	Time	Method
Adverse events	28 Days	Number, type, severity, and association of treatment emergent adverse events.

Secondary Outcome Measures

Name	Time	Method
Tmax	28 Days	Tmax
Cmax	28 Days	Cmax
AUC0-24	28 Days
AUC0-t	28 Days
AUC0-∞	28 Days	AUC0-∞
Antiviral Activity	28 Days	Change from baseline in HCV RNA
t1/2	28 Days	t1/2

Trial Locations

Locations (1)

Texas Liver Institute; 🇺🇸 San Antonio, Texas, United States