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TD-6450 MAD Study in HCV Infected Subjects

Sponsor
Theravance Biopharma (Industry)
Overall Status
Completed
CT.gov ID
NCT02116543
Collaborator
(none)
47
Enrollment
1
Location
2
Arms
6
Duration (Months)
7.8
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
47 participants
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official 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)
Study Start Date :
May 1, 2014
Actual Primary Completion Date :
Oct 1, 2014
Actual Study Completion Date :
Nov 1, 2014

Arms and Interventions

Arm Intervention/Treatment
Experimental: TD-6450

TD-6450 capsules

Drug: TD-6450
Placebo Comparator: Placebo

Placebo capsules

Drug: Placebo

Outcome Measures

Primary Outcome Measures

  1. Adverse events [28 Days]

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

Secondary Outcome Measures

  1. Cmax [28 Days]

    Cmax

  2. Tmax [28 Days]

    Tmax

  3. AUC0-t [28 Days]

  4. AUC0-∞ [28 Days]

    AUC0-∞

  5. AUC0-24 [28 Days]

  6. Antiviral Activity [28 Days]

    Change from baseline in HCV RNA

  7. t1/2 [28 Days]

    t1/2

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Texas Liver Institute San Antonio Texas United States 78215

Sponsors and Collaborators

  • Theravance Biopharma

Investigators

  • Study Director: Medical Monitor, Theravance Biopharma

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Theravance Biopharma
ClinicalTrials.gov Identifier:
NCT02116543
Other Study ID Numbers:
  • 0110
First Posted:
Apr 17, 2014
Last Update Posted:
Jan 19, 2021
Last Verified:
Jan 1, 2021
Keywords provided by Theravance Biopharma
Hepatitis C
HCV
Additional relevant MeSH terms:
Hepatitis A
Hepatitis C
Hepatitis

Study Results

No Results Posted as of Jan 19, 2021