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

NCT ID: NCT00445315

Last Updated: 2014-02-17

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-01-31

Study Completion Date

2008-06-30

Brief Summary

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

Detailed Description

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Conditions

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Hepatitis C

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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2

Group Type EXPERIMENTAL

PF-00868554

Intervention Type DRUG

450 mg BID

3

Group Type EXPERIMENTAL

PF-00868554

Intervention Type DRUG

100 mg BID

1

Group Type EXPERIMENTAL

PF-00868554

Intervention Type DRUG

300 mg BID

4

Group Type EXPERIMENTAL

PF-00868554

Intervention Type DRUG

300 mg TID

5

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo

Interventions

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PF-00868554

300 mg BID

Intervention Type DRUG

PF-00868554

450 mg BID

Intervention Type DRUG

PF-00868554

100 mg BID

Intervention Type DRUG

PF-00868554

300 mg TID

Intervention Type DRUG

Placebo

Placebo

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Brussels, , Belgium

Site Status

Pfizer Investigational Site

Berlin, , Germany

Site Status

Pfizer Investigational Site

Berlin, , Germany

Site Status

Pfizer Investigational Site

Dundee, , United Kingdom

Site Status

Countries

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Belgium Germany United Kingdom

References

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Wagner F, Thompson R, Kantaridis C, Simpson P, Troke PJ, Jagannatha S, Neelakantan S, Purohit VS, Hammond JL. Antiviral activity of the hepatitis C virus polymerase inhibitor filibuvir in genotype 1-infected patients. Hepatology. 2011 Jul;54(1):50-9. doi: 10.1002/hep.24342.

Reference Type DERIVED
PMID: 21488067 (View on PubMed)

Related Links

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Other Identifiers

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A8121002

Identifier Type: -

Identifier Source: org_study_id

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