A Phase 1 Single-Dose Escalation Study of PF-04308515 in Healthy Volunteers
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).
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, 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|
- To evaluate the safety, tolerability and pharmacokinetics (PK) of single-rising doses of PF-04308515 [ Time Frame: 1 day ] [ Designated as safety issue: Yes ]
- To characterize the pharmacodynamic (PD) effects of PF-04308515 on biomarkers [ Time Frame: 1 day ] [ Designated as safety issue: No ]
|Study Start Date:||October 2009|
|Study Completion Date:||January 2010|
|Primary Completion Date:||January 2010 (Final data collection date for primary outcome measure)|
Oral solution/suspension 0.1 mg up to potentially 350 mg QD at a single dose.
|Placebo Comparator: Placebo||
Placebo solution/suspension to match active drug QD at a single dose.