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Antiviral Activity of AZD7295 in HCV Carriers

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00781976
First Posted: October 29, 2008
Last Update Posted: March 31, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Arrow Therapeutics
  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
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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 ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • HCV carrier

Exclusion Criteria:

  • concurrent medications
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Liz Clark, Arrow Therapeutics
ClinicalTrials.gov Identifier: NCT00781976     History of Changes
Other Study ID Numbers: HCV689-102
First Submitted: October 28, 2008
First Posted: October 29, 2008
Last Update Posted: March 31, 2010
Last Verified: March 2010

Additional relevant MeSH terms:
Hepatitis
Hepatitis C
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Flaviviridae Infections
RNA Virus Infections
Antiviral Agents
Anti-Infective Agents