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

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ClinicalTrials.gov Identifier: NCT00990015
Recruitment Status : Completed
First Posted : October 6, 2009
Last Update Posted : February 1, 2010
Sponsor:
Information provided by:
Pfizer

Study Description
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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).

Condition or disease Intervention/treatment Phase
Healthy Volunteers Drug: PF-04308515 Drug: Placebo Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, 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
Study Start Date : October 2009
Actual Primary Completion Date : January 2010
Actual Study Completion Date : January 2010
Arms and Interventions
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Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. To evaluate the safety, tolerability and pharmacokinetics (PK) of single-rising doses of PF-04308515 [ Time Frame: 1 day ]
  2. To characterize the pharmacodynamic (PD) effects of PF-04308515 on biomarkers [ Time Frame: 1 day ]

Eligibility Criteria
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:
To obtain contact information for a study center near you, click here.  This link exits the ClinicalTrials.gov site

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00990015     History of Changes
Other Study ID Numbers: B0861001
First Posted: October 6, 2009    Key Record Dates
Last Update Posted: February 1, 2010
Last Verified: January 2010

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