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

Pfizer

Status and phase: Completed; Phase 1

Conditions: Hepatitis C

Treatments: Drug: PF-00868554; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00445315

A8121002

Details and patient eligibility

About

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

Enrollment: 32 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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32 participants in 5 patient groups, including a placebo group

2

Experimental group

Treatment:

Drug: PF-00868554

Drug: PF-00868554

Drug: PF-00868554

Drug: PF-00868554

3

Experimental group

Treatment:

Drug: PF-00868554

Drug: PF-00868554

Drug: PF-00868554

Drug: PF-00868554

1

Experimental group

Treatment:

Drug: PF-00868554

Drug: PF-00868554

Drug: PF-00868554

Drug: PF-00868554

4

Experimental group

Treatment:

Drug: PF-00868554

Drug: PF-00868554

Drug: PF-00868554

Drug: PF-00868554

5

Placebo Comparator group

Treatment:

Drug: Placebo