Back to resultsBioavailability Study Of PF-00868554 Administered As 3x250mg Oral Tablets (Wet Granulate, 3x250mg Oral Tablets (Dry Granulate) And 750mg Solution Under Fed State
Primary Purpose
Hepatitis C Virus
Status
Completed
Phase
Phase 1
Locations
Belgium
Study Type
Interventional
Intervention
Pharmacokinetics
Sponsored by
About this trial
This is an interventional basic science trial for Hepatitis C Virus
Eligibility Criteria
Inclusion Criteria:
- Healthy volunteers.
Exclusion Criteria:
- Standard for healthy volunteers.
Sites / Locations
- Pfizer Investigational Site
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
PF-00868554
Arm Description
Outcomes
Primary Outcome Measures
AUC inf, Cmax
Secondary Outcome Measures
Adverse events
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00861458
Brief Title
Bioavailability Study Of PF-00868554 Administered As 3x250mg Oral Tablets (Wet Granulate, 3x250mg Oral Tablets (Dry Granulate) And 750mg Solution Under Fed State
Official Title
A Phase 1, Open-Label, Randomized, 3-Way Crossover Study In Healthy Subjects To Estimate The Pharmacokinetics Of PF-00868554 Administered As 3x250mg Oral Tablets (Wet Granulate, 3x250mg Oral Tablets (Dry Granulate) And 750mg Solution Under Fed State
Study Type
Interventional
2. Study Status
Record Verification Date
July 2009
Overall Recruitment Status
Completed
Study Start Date
April 2009 (undefined)
Primary Completion Date
June 2009 (Actual)
Study Completion Date
June 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Pfizer
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study will test two different formulations. The results will be used to select formulation for phase 3.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis C Virus
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
14 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PF-00868554
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Pharmacokinetics
Other Intervention Name(s)
pharmacokintics
Intervention Description
Single dose of 750 mg PF-00868554 as a solution and tablets.
Primary Outcome Measure Information:
Title
AUC inf, Cmax
Time Frame
2 days
Secondary Outcome Measure Information:
Title
Adverse events
Time Frame
2 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy volunteers.
Exclusion Criteria:
Standard for healthy volunteers.
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
Bruxelles
ZIP/Postal Code
1070
Country
Belgium
12. IPD Sharing Statement
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A8121010&StudyName=Bioavailability%20Study%20Of%20PF-00868554%20Administered%20As%203x250mg%20Oral%20Tablets%20%28Wet%20Granulate%2C%203x250mg%20Oral%20Tablets%20%28Dry%20Granulate%29%20And%207
Description
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Bioavailability Study Of PF-00868554 Administered As 3x250mg Oral Tablets (Wet Granulate, 3x250mg Oral Tablets (Dry Granulate) And 750mg Solution Under Fed State
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