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A Phase 1 Study Of PF-00868554 In Hepatitis C Virus (HCV) Positive Patients

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00445315
First received: March 6, 2007
Last updated: April 21, 2011
Last verified: April 2011
History of Changes
  Purpose

Assess the safety, tolerability and pharmacokinetics of multiple oral doses of PF-00868554 in HCV positive patient volunteers


Condition Intervention Phase
Hepatitis C
 Drug: PF-00868554
Drug: Placebo
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 1, Randomized, Double Blind (3rd Party Open), Placebo-controlled, Sequential Group, Multicentre Study To Evaluate The Multiple Dose Safety, Tolerability, Pharmacokinetics And Pharmacodynamics, of PF-00868554 in Hepatitis C Virus (HCV) Positive Otherwise Healthy Patient Volunteers

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • PF-00868554 safety, tolerability and pharmacokinetics. [ Time Frame: 8 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in viral load from baseline to Day 8, PK/PD, and emergence of resistant variants. [ Time Frame: 8 days ] [ Designated as safety issue: No ]

Enrollment: 32
Study Start Date: January 2007
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 2 Drug: PF-00868554
450 mg BID
Experimental: 3 Drug: PF-00868554
100 mg BID
Experimental: 1 Drug: PF-00868554
300 mg BID
Experimental: 4 Drug: PF-00868554
300 mg TID
Placebo Comparator: 5 Drug: Placebo
Placebo

  Eligibility

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

Inclusion Criteria:

  • HCV RNA ≥ 100,000 IU/mL at screening
  • Genotype 1a or 1b

Exclusion Criteria:

  • Current or prior treatment with IFN and/or RBV
  • Evidence of decompensated liver disease
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00445315

Locations
Belgium
Pfizer Investigational Site
Bruxelles, Belgium, 1070
Germany
Pfizer Investigational Site
Berlin, Germany, 10117
Pfizer Investigational Site
Berlin, Germany, 12351
United Kingdom
Pfizer Investigational Site
Dundee, United Kingdom, DD1 9SY
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

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

No publications provided by Pfizer

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00445315     History of Changes
Other Study ID Numbers: A8121002
Study First Received: March 6, 2007
Last Updated: April 21, 2011
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on June 17, 2013