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

Phase 1CompletedNCT00810758

Pfizer24 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Hepatitis C Virus

Interventions

PF-04878691 3mgDRUG

Oral solution, 3mg, twice weekly, 2 weeks

PF-04878691 6mgDRUG

Oral solution, 6mg, twice weekly, 2 weeks

PF-04878691 9mgDRUG

Oral solution, 9mg, twice weekly, 2 weeks

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Pfizer Investigational Site

New Haven, Connecticut, United States

Outcomes

Primary Outcomes

To assess the safety and toleration of multiple ascending oral doses of PF-04878691

Time frame: 3 weeks

Secondary Outcomes

To assess the pharmacokinetics and pharmacodynamics with regards to specific biomarkers of immune stimulation of PF-04878691

Time frame: 3 weeks

Data from ClinicalTrials.gov

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