A Phase 1 Single-Dose Escalation Study of PF-04308515 in Healthy Volunteers
A Phase 1, Randomized, Double-Blind, Sponsor-Open, Placebo-Controlled, Single-Dose Escalation Trial Evaluating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of PF-04308515 in Healthy Volunteers
1 other identifier
interventional
27
1 country
1
Brief Summary
The purpose of this study is to determine the safety, tolerability, pharmacokinetics (understanding how a drug is absorbed and moves through the body) and pharmacodynamics (understanding the effects of a drug on certain target sites of activity in the body).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 healthy-volunteers
Started Oct 2009
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
October 1, 2009
CompletedFirst Submitted
Initial submission to the registry
October 2, 2009
CompletedFirst Posted
Study publicly available on registry
October 6, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2010
CompletedFebruary 1, 2010
January 1, 2010
3 months
October 2, 2009
January 29, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
To evaluate the safety, tolerability and pharmacokinetics (PK) of single-rising doses of PF-04308515
1 day
To characterize the pharmacodynamic (PD) effects of PF-04308515 on biomarkers
1 day
Study Arms (2)
PF-04308515
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Oral solution/suspension 0.1 mg up to potentially 350 mg QD at a single dose.
Eligibility Criteria
You may qualify if:
- Healthy males between 18 and 55 years, inclusive
- Healthy females between 18 and 44 years, inclusive.
- Women need to be surgically sterile
You may not qualify if:
- Evidence or history of clinically significant disease
- Post-menopausal women
- History of intolerance or significant adverse effects with glucocorticoids
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (1)
Pfizer Investigational Site
New Haven, Connecticut, 06511, United States
Related Links
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
October 2, 2009
First Posted
October 6, 2009
Study Start
October 1, 2009
Primary Completion
January 1, 2010
Study Completion
January 1, 2010
Last Updated
February 1, 2010
Record last verified: 2010-01