NCT00314054

Brief Summary

The purpose of this study is to assess the pharmacokinetics (PK) of HCV-796 in subjects with chronic hepatic impairment and in matched healthy adults.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
27

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started May 2006

Geographic Reach
1 country

3 active sites

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

April 10, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 12, 2006

Completed
19 days until next milestone

Study Start

First participant enrolled

May 1, 2006

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2007

Completed
Last Updated

April 14, 2008

Status Verified

April 1, 2008

Enrollment Period

1.4 years

First QC Date

April 10, 2006

Last Update Submit

April 10, 2008

Conditions

Hepatitis CHepatic Insufficiency

Keywords

Hepatitis CHepatic ImpairmentHealthy VolunteerPhase 1Hepacivirus

Outcome Measures

Primary Outcomes (1)

  • To assess PK in subjects with chronic hepatic impairment and in matched healthy adults

    7 days

Secondary Outcomes (1)

  • To assess the safety and tolerability in subjects with chronic hepatic impairment and in matched healthy adults

    15 days

Study Arms (1)

1

EXPERIMENTAL

HCV-796 1000mg single dose

Drug: HCV-796

Interventions

HCV-796DRUG

HCV-796 1000mg single dose

1

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Men and women of non-childbearing potential.
  • Hepatic impairment subjects: Child-Pugh class A, B, or C according to the C-P classification based on history, physical examination, and laboratory test results.
  • Healthy volunteers: healthy as determined by the investigator.

You may not qualify if:

  • History of alcoholism within 1 year.
  • Hepatic impairment subjects: evidence of unstable clinically significant disease other than impaired hepatic function.
  • Healthy volunteers: positive serologic findings for hepatitis B surface antigen (HBsAg) and/or hepatitis C virus (HCV) antibodies.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Unknown Facility

Gainesville, Florida, 32608, United States

Location

Unknown Facility

Orlando, Florida, 32809, United States

Location

Unknown Facility

Saint Paul, Minnesota, 55114, United States

Location

MeSH Terms

Conditions

Hepatitis CHepatic Insufficiency

Interventions

HCV 796

Condition Hierarchy (Ancestors)

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

Study Officials

  • Medical Monitor

    Wyeth is now a wholly owned subsidiary of Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

April 10, 2006

First Posted

April 12, 2006

Study Start

May 1, 2006

Primary Completion

October 1, 2007

Study Completion

October 1, 2007

Last Updated

April 14, 2008

Record last verified: 2008-04

Locations

US(3)