Single Dose Study Of PF-04308515 And Prednisone On Carbohydrate
An Open Label Study Evaluating The Effect Of Single Doses Of Pf-04308515 And Prednisone On Carbohydrate Metabolism Utilizing An Oral Glucose Tolerance Test In Healthy Adult Subjects
1 other identifier
interventional
18
1 country
1
Brief Summary
This study will investigate the effect of a single dose of PF-04308515 or prednisone on calculated measures of glucose tolerance and insulin resistance by using a modified oral glucose tolerance test.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1 healthy
Started Aug 2010
Shorter than P25 for phase_1 healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2010
CompletedFirst Submitted
Initial submission to the registry
September 9, 2010
CompletedFirst Posted
Study publicly available on registry
September 10, 2010
CompletedDecember 16, 2010
December 1, 2010
1 month
September 9, 2010
December 15, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Fold change in AUC (0-4hr) relative to no treatment baseline for plasma glucose, plasma insulin and plasma C-peptide
4 hours
Secondary Outcomes (3)
Pharmacodynamic effects on plasma glucose, plasma insulin, and plasma C-peptide
3 days
Safety: adverse events, vital sign measurements, physical examination
3 days
Pharmacokinetics: sparse PF-04308515 plasma samples will be collected
3 days
Study Arms (7)
(Part 1) 10 mg PF-04308515 (8hrs)
EXPERIMENTAL(Part 1) 10 mg PF-04308515 (12hrs)
EXPERIMENTAL(Part 1) 5 mg Prednisone
ACTIVE COMPARATOR(Part 2) X mg PF-04308515
EXPERIMENTAL(Part 2) Y mg PF-04308515
EXPERIMENTAL(Part 2) 5 mg Prednisone
ACTIVE COMPARATOR(Part 2) 20 mg Prednisone
ACTIVE COMPARATORInterventions
10 mg extemporaneous preparation of oral solution predosed 8 hours prior to Oral Glucose Tolerance Test(OGTT)
5 mg tablet predosed at 8 hours prior to Oral Glucose Tolerance Test (OGTT)
Eligibility Criteria
You may qualify if:
- BMI 17.5 to 30.5 kg/m2 and total body weight \>50 kg
You may not qualify if:
- Fasting glucose above the limits of the reference range for healthy individuals
- "No treatment" OGTT indicative of impaired fasting glucose or impaired glucose tolerance
- Severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (1)
Pfizer Investigational Site
Kalamazoo, Michigan, 49007, United States
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 9, 2010
First Posted
September 10, 2010
Study Start
August 1, 2010
Primary Completion
September 1, 2010
Study Completion
September 1, 2010
Last Updated
December 16, 2010
Record last verified: 2010-12