Antiviral Activity of AZD7295 in HCV Carriers

Hepatitis C Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00781976
• Other study ID #: HCV689-102
• Status: Completed
• Phase: Phase 1
• First received: October 28, 2008
• Last updated: March 30, 2010
• Start date: November 2008
• Est. completion date: March 2010

Study information

• Verified date: March 2010
• Source: Arrow Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory AgencyNew Zealand: MedsafeSpain: regulatory authority
• Study type: Interventional

Clinical Trial Summary

PK, safety study of AZD7295 in HCV carriers

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: March 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• HCV carrier

Exclusion Criteria:

• concurrent medications

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis C

Intervention

Drug:
• AZD7295
700mg per day maximum
• Placebo
matched placebo

Locations

Country	Name	City	State
New Zealand	Prof Ed Gane	Auckland

Sponsors (1)

Lead Sponsor	Collaborator
Arrow Therapeutics

Country where clinical trial is conducted

New Zealand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma AZD7295 concentrations and pharmacokinetics		5 days	No