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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00990015
First received: October 2, 2009
Last updated: January 29, 2010
Last verified: January 2010
  Purpose

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 Intervention Phase
Healthy Volunteers
Drug: PF-04308515
Drug: Placebo
Phase 1

Study Type: Interventional
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

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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 ]

Enrollment: 27
Study Start Date: October 2009
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00990015

Locations
United States, Connecticut
Pfizer Investigational Site
New Haven, Connecticut, United States, 06511
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00990015     History of Changes
Other Study ID Numbers: B0861001
Study First Received: October 2, 2009
Last Updated: January 29, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Safety; tolerability; pharmacokinetics/pharmacodynamics

ClinicalTrials.gov processed this record on April 17, 2014