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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 23, 2014