Antiviral Activity of AZD7295 in HCV Carriers

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. Identifier: NCT00781976
Recruitment Status : Completed
First Posted : October 29, 2008
Last Update Posted : March 31, 2010
Information provided by:
Arrow Therapeutics

Brief Summary:
PK, safety study of AZD7295 in HCV carriers

Condition or disease Intervention/treatment Phase
Hepatitis C Drug: AZD7295 Drug: Placebo Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
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
Study Start Date : November 2008
Actual Primary Completion Date : March 2010
Actual Study Completion Date : March 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Placebo Comparator: 1 Drug: Placebo
matched placebo
Active Comparator: 2 Drug: AZD7295
700mg per day maximum

Primary Outcome Measures :
  1. Plasma AZD7295 concentrations and pharmacokinetics [ Time Frame: 5 days ]

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

Inclusion Criteria:

  • HCV carrier

Exclusion Criteria:

  • concurrent medications

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 identifier (NCT number): NCT00781976

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

Responsible Party: Liz Clark, Arrow Therapeutics Identifier: NCT00781976     History of Changes
Other Study ID Numbers: HCV689-102
First Posted: October 29, 2008    Key Record Dates
Last Update Posted: March 31, 2010
Last Verified: March 2010

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