A Phase 1 Single-Dose Escalation Study of PF-04308515 in Healthy Volunteers
Sponsor
Pfizer (Industry)
Overall Status
Completed
CT.gov ID
NCT00990015
Collaborator
(none)
27
1
2
3
8.9
Study Details
Study Description
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
27 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Basic Science
Official Title:
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
Study Start Date
:
Oct 1, 2009
Actual Primary Completion Date
:
Jan 1, 2010
Actual Study Completion Date
:
Jan 1, 2010
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: PF-04308515
|
Drug: PF-04308515
Oral solution/suspension 0.1 mg up to potentially 350 mg QD at a single dose.
|
| Placebo Comparator: Placebo
|
Drug: Placebo
Placebo solution/suspension to match active drug QD at a single dose.
|
Outcome Measures
Primary Outcome Measures
- 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]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 55 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
-
Healthy males between 18 and 55 years, inclusive
-
Healthy females between 18 and 44 years, inclusive.
-
Women need to be surgically sterile
Exclusion Criteria:
-
Evidence or history of clinically significant disease
-
Post-menopausal women
-
History of intolerance or significant adverse effects with glucocorticoids
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Pfizer Investigational Site | New Haven | Connecticut | United States | 06511 |
Sponsors and Collaborators
- Pfizer
Investigators
- Study Director: Pfizer CT.gov Call Center, Pfizer
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00990015
Other Study ID Numbers:
- B0861001
First Posted:
Oct 6, 2009
Last Update Posted:
Feb 1, 2010
Last Verified:
Jan 1, 2010
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