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

Healthy Volunteers Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00990015
• Other study ID #: B0861001
• Status: Completed
• Phase: Phase 1
• First received: October 2, 2009
• Last updated: January 29, 2010
• Start date: October 2009
• Est. completion date: January 2010

Study information

• Verified date: January 2010
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: January 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• PF-04308515
Oral solution/suspension 0.1 mg up to potentially 350 mg QD at a single dose.
• Placebo
Placebo solution/suspension to match active drug QD at a single dose.

Locations

Country	Name	City	State
United States	Pfizer Investigational Site	New Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the safety, tolerability and pharmacokinetics (PK) of single-rising doses of PF-04308515		1 day	Yes
Primary	To characterize the pharmacodynamic (PD) effects of PF-04308515 on biomarkers		1 day	No

External Links

•   To obtain contact information for a study center near you, click here.