Phase 1 Study To Evaluate Antiviral Activity Of Small Molecule Direct Antiviral Agent At Multiple Doses In Subjects With Chronically Infected Hepatitis C Virus. - Full Text View

Purpose

Phase 1 study in HVC (Hepatitis C Virus) infected subjects to determine pharmacokinetics, safety and efficacy in subjects with no or inadequate response to prior treatment.

Condition	Intervention	Phase
Hepatitis, Chronic Hepatitis C Virus	Drug: Small Molecule Agent (PF-868554)	Phase I

MedlinePlus related topics:

Hepatitis Hepatitis C

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Parallel Assignment, Pharmacokinetics/Dynamics Study

Official Title:	A Phase 1, Non- Randomized, Open Label, Sequential Group, Multicenter Study To Evaluate The Antiviral Activity Of Multiple Doses Of A Small Molecule Direct Antiviral Agent In Chronically Infected Hepatitis C Subjects.

Further study details as provided by Pfizer:

Primary Outcome Measures:

Change from baseline in plasma hcv rna for each treatment group and dosing regimes studied [ Time Frame: NADIR to day 11 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Safety, tolerability and pharmacokinetics for each treatment group and dosing regimen studied [ Time Frame: Day 0 to day 11 ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	20
Study Start Date:	April 2008
Estimated Study Completion Date:	January 2009
Estimated Primary Completion Date:	January 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Cohort B: Experimental	Drug: Small Molecule Agent (PF-868554) Study drug will be administered 700mg BID in the fed state for three days.
Cohort A: Experimental Dose study drug in subjects who have previously failed to respond to interferon based therapies	Drug: Small Molecule Agent (PF-868554) Study drug will be given 450mg BID for a duration of 10 days.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

HCV Positive With HCV RNA>100,000 iu/ml Genotype 1; COHORT A- non responders or partial

Exclusion Criteria:

HIV HBV co-infection Decompensated liver disease Liver disease due to causes other than HCV, AFP>200ng/ml

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00671671

Locations


United States, Florida
	Pfizer Investigational Site
	Gainesville, Florida, United States, 32608

Sponsors and Collaborators

Pfizer

Investigators


Study Director:	Pfizer CT.gov Call Center	Pfizer

More Information

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

Responsible Party:	Pfizer, Inc. ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A8121006
First Received:	April 25, 2008
Last Updated:	October 9, 2008
ClinicalTrials.gov Identifier:	NCT00671671
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Virus Diseases

Hepatitis

Liver Diseases

Digestive System Diseases

Hepatitis, Chronic

Hepatitis, Viral, Human

Hepatitis C

Additional relevant MeSH terms:

RNA Virus Infections

Flaviviridae Infections

ClinicalTrials.gov processed this record on October 10, 2008

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00671671