NCT00781976

Brief Summary

PK, safety study of AZD7295 in HCV carriers

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Nov 2008

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 28, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 29, 2008

Completed
3 days until next milestone

Study Start

First participant enrolled

November 1, 2008

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed
Last Updated

March 31, 2010

Status Verified

March 1, 2010

Enrollment Period

1.3 years

First QC Date

October 28, 2008

Last Update Submit

March 30, 2010

Conditions

Hepatitis C

Outcome Measures

Primary Outcomes (1)

  • Plasma AZD7295 concentrations and pharmacokinetics

    5 days

Study Arms (2)

1

PLACEBO COMPARATOR
Drug: Placebo

2

ACTIVE COMPARATOR
Drug: AZD7295

Interventions

AZD7295DRUG

700mg per day maximum

2
PlaceboDRUG

matched placebo

1

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • HCV carrier

You may not qualify if:

  • concurrent medications

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Prof Ed Gane

Auckland, New Zealand

Location

MeSH Terms

Conditions

Hepatitis C

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitisLiver DiseasesDigestive System Diseases

Study Officials

  • Ed Gane

    Auckland Clinical Services

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 28, 2008

First Posted

October 29, 2008

Study Start

November 1, 2008

Primary Completion

March 1, 2010

Study Completion

March 1, 2010

Last Updated

March 31, 2010

Record last verified: 2010-03

Locations

NZ(1)