Back to resultsMultiple Oral Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of PF-04878691
Primary Purpose
Hepatitis C Virus
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
PF-04878691 3mg
PF-04878691 6mg
PF-04878691 9mg
Sponsored by
About this trial
This is an interventional treatment trial for Hepatitis C Virus focused on measuring HCV, Toll-like receptor 7, Multiple oral dose escalation study of PF-04878691
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.
Sites / Locations
- Pfizer Investigational Site
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
PF-04878691
Arm Description
Outcomes
Primary Outcome Measures
To assess the safety and toleration of multiple ascending oral doses of PF-04878691
Secondary Outcome Measures
To assess the pharmacokinetics and pharmacodynamics with regards to specific biomarkers of immune stimulation of PF-04878691
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00810758
Brief Title
Multiple Oral Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of PF-04878691
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2009
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
November 2009 (Actual)
Study Completion Date
November 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Pfizer
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
To assess the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple oral doses of PF-04878691.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis C Virus
Keywords
HCV, Toll-like receptor 7, Multiple oral dose escalation study of PF-04878691
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PF-04878691
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
PF-04878691 3mg
Intervention Description
Oral solution, 3mg, twice weekly, 2 weeks
Intervention Type
Drug
Intervention Name(s)
PF-04878691 6mg
Intervention Description
Oral solution, 6mg, twice weekly, 2 weeks
Intervention Type
Drug
Intervention Name(s)
PF-04878691 9mg
Intervention Description
Oral solution, 9mg, twice weekly, 2 weeks
Primary Outcome Measure Information:
Title
To assess the safety and toleration of multiple ascending oral doses of PF-04878691
Time Frame
3 weeks
Secondary Outcome Measure Information:
Title
To assess the pharmacokinetics and pharmacodynamics with regards to specific biomarkers of immune stimulation of PF-04878691
Time Frame
3 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06511
Country
United States
12. IPD Sharing Statement
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B1201002&StudyName=Multiple%20Oral%20Dose%20Study%20to%20Evaluate%20the%20Safety%2C%20Tolerability%2C%20Pharmacokinetics%20and%20Pharmacodynamics%20of%20PF-04878691
Description
To obtain contact information for a study center near you, click here.
Learn more about this trial
Multiple Oral Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of PF-04878691
We'll reach out to this number within 24 hrs