A Phase 1 Single-Dose Escalation Study of PF-04308515 in Healthy Volunteers
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00990015 |
Recruitment Status
:
Completed
First Posted
: October 6, 2009
Last Update Posted
: February 1, 2010
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Healthy Volunteers | Drug: PF-04308515 Drug: Placebo | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
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 : | October 2009 |
Actual Primary Completion Date : | January 2010 |
Actual Study Completion Date : | January 2010 |
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.
|
- To evaluate the safety, tolerability and pharmacokinetics (PK) of single-rising doses of PF-04308515 [ Time Frame: 1 day ]
- To characterize the pharmacodynamic (PD) effects of PF-04308515 on biomarkers [ Time Frame: 1 day ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 55 Years (Adult) |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00990015
United States, Connecticut | |
Pfizer Investigational Site | |
New Haven, Connecticut, United States, 06511 |
Study Director: | Pfizer CT.gov Call Center | Pfizer |
Additional Information:
Responsible Party: | Director, Clinical Trial Disclosure Group, Pfizer, Inc. |
ClinicalTrials.gov Identifier: | NCT00990015 History of Changes |
Other Study ID Numbers: |
B0861001 |
First Posted: | October 6, 2009 Key Record Dates |
Last Update Posted: | February 1, 2010 |
Last Verified: | January 2010 |
Keywords provided by Pfizer:
Safety; tolerability; pharmacokinetics/pharmacodynamics |