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

Phase 1

Completed

• Conditions: Hepatitis C Virus
• Interventions: Drug: PF-04878691 3mg; Drug: PF-04878691 6mg; Drug: PF-04878691 9mg

• Registration Number: NCT00810758
• Lead Sponsor: Pfizer

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-12-17
• Study First Submitted QC: 2008-12-17
• Study First Posted: 2008-12-18
• Study Start: 2009-01
• Status Verified: 2009-11
• Primary Completion: 2009-11
• Study Completion: 2009-11
• Last Update Submitted: 2009-11-30
• Last Update Posted: 2009-12-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PF-04878691	PF-04878691 3mg	-
PF-04878691	PF-04878691 6mg	-
PF-04878691	PF-04878691 9mg	-

Primary Outcome Measures

Name	Time	Method
To assess the safety and toleration of multiple ascending oral doses of PF-04878691	3 weeks

Secondary Outcome Measures

Name	Time	Method
To assess the pharmacokinetics and pharmacodynamics with regards to specific biomarkers of immune stimulation of PF-04878691	3 weeks

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇺🇸 New Haven, Connecticut, United States