Antiviral Activity of AZD7295 in HCV Carriers

This study has been completed.
Sponsor:
Information provided by:
Arrow Therapeutics
ClinicalTrials.gov Identifier:
NCT00781976
First received: October 28, 2008
Last updated: March 30, 2010
Last verified: March 2010
  Purpose

PK, safety study of AZD7295 in HCV carriers


Condition Intervention Phase
Hepatitis C
Drug: AZD7295
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomised, DB, PC Study to Determine the PK, Safety and Tolerability Profile and Antiviral Activity of Multiple Oral Doses of AZD7295 in Otherwise Healthy Male and Female Hepatitis C Carriers With Compensated Liver Disease

Resource links provided by NLM:


Further study details as provided by Arrow Therapeutics:

Primary Outcome Measures:
  • Plasma AZD7295 concentrations and pharmacokinetics [ Time Frame: 5 days ] [ Designated as safety issue: No ]

Enrollment: 31
Study Start Date: November 2008
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 1 Drug: Placebo
matched placebo
Active Comparator: 2 Drug: AZD7295
700mg per day maximum

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • HCV carrier

Exclusion Criteria:

  • concurrent medications
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00781976

Locations
New Zealand
Prof Ed Gane
Auckland, New Zealand
Sponsors and Collaborators
Arrow Therapeutics
Investigators
Principal Investigator: Ed Gane Auckland Clinical Services
  More Information

No publications provided

Responsible Party: Liz Clark, Arrow Therapeutics
ClinicalTrials.gov Identifier: NCT00781976     History of Changes
Other Study ID Numbers: HCV689-102
Study First Received: October 28, 2008
Last Updated: March 30, 2010
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
New Zealand: Medsafe
Spain: regulatory authority

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 22, 2014