Multiple Oral Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of PF-04878691

Pfizer

Status and phase: Completed; Phase 1

Conditions: Hepatitis C Virus

Treatments: Drug: PF-04878691 6mg; Drug: PF-04878691 9mg; Drug: PF-04878691 3mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT00810758

B1201002

Details and patient eligibility

About

To assess the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple oral doses of PF-04878691.

Enrollment: 24 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy male and/or female subjects between the ages of 18-55, inclusive.
• Body Mass Index (BMI) of 18-30 kg/m2; total body weight >50kg (110lbs).

Exclusion criteria

• Pregnant or nursing females.
• Females of child-bearing potential.
• Evidence of history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, allergic or autoimmune disease or clinical findings at screening.
• Smoking within the previous 6 months.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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24 participants in 1 patient group

PF-04878691

Experimental group

Treatment:

Drug: PF-04878691 9mg

Drug: PF-04878691 3mg

Drug: PF-04878691 6mg