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A Phase 1 Study Of PF-00868554 In Hepatitis C Virus (HCV) Positive Patients
This study has been completed.
Sponsored by: Pfizer
Information provided by: Pfizer
ClinicalTrials.gov Identifier: NCT00445315
  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 I
Phase II

MedlinePlus related topics: Hepatitis Hepatitis C
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Single Group Assignment, Safety Study
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

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: 33
Study Start Date: January 2007
Study Completion Date: May 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
2: Experimental Drug: PF-00868554
450 mg BID
3: Experimental Drug: PF-00868554
100 mg BID
1: Experimental Drug: PF-00868554
300 mg BID
4: Experimental Drug: PF-00868554
300 mg TID
5: Placebo Comparator 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

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: A8121002
Study First Received: March 6, 2007
Last Updated: July 8, 2008
ClinicalTrials.gov Identifier: NCT00445315  
Health Authority: United States: Food and Drug Administration

Study placed in the following topic categories:
Virus Diseases
Hepatitis
Liver Diseases
Digestive System Diseases
 Hepatitis, Viral, Human
Healthy
Hepatitis C

Additional relevant MeSH terms:
RNA Virus Infections
Flaviviridae Infections

ClinicalTrials.gov processed this record on January 16, 2009



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