NCT00810758
Completed
Phase 1
A Phase 1, Randomized, Placebo Controlled, Blinded (3rd Party Open), Sequential, Multiple-Dose Escalation Study To Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of PF-04878691 In Healthy Volunteers
ConditionsHepatitis C Virus
Overview
- Phase
- Phase 1
- Intervention
- PF-04878691 3mg
- Conditions
- Hepatitis C Virus
- Sponsor
- Pfizer
- Enrollment
- 24
- Locations
- 1
- Primary Endpoint
- To assess the safety and toleration of multiple ascending oral doses of PF-04878691
- Status
- Completed
- Last Updated
- 16 years ago
Overview
Brief Summary
To assess the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple oral doses of PF-04878691.
Investigators
Eligibility Criteria
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.
Arms & Interventions
PF-04878691
Intervention: PF-04878691 3mg
PF-04878691
Intervention: PF-04878691 6mg
PF-04878691
Intervention: PF-04878691 9mg
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(3 weeks)
Study Sites (1)
Loading locations...
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