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
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, see Learn About Clinical Studies.

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 July 31, 2014