A Phase 1 Single-Dose Escalation Study of PF-04308515 in Healthy Volunteers

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: PF-04308515; Drug: Placebo

• Registration Number: NCT00990015
• Lead Sponsor: Pfizer

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2009-10
• Study First Submitted: 2009-10-02
• Study First Submitted QC: 2009-10-05
• Study First Posted: 2009-10-06
• Status Verified: 2010-01
• Primary Completion: 2010-01
• Study Completion: 2010-01
• Last Update Submitted: 2010-01-29
• Last Update Posted: 2010-02-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
PF-04308515	PF-04308515	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇺🇸 New Haven, Connecticut, United States