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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

Tracking Information
First Submitted Date  ICMJE October 2, 2009
First Posted Date  ICMJE October 6, 2009
Last Update Posted Date February 1, 2010
Study Start Date  ICMJE October 2009
Actual Primary Completion Date January 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 5, 2009)
  • To evaluate the safety, tolerability and pharmacokinetics (PK) of single-rising doses of PF-04308515 [ Time Frame: 1 day ]
  • To characterize the pharmacodynamic (PD) effects of PF-04308515 on biomarkers [ Time Frame: 1 day ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00990015 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Phase 1 Single-Dose Escalation Study of PF-04308515 in Healthy Volunteers
Official Title  ICMJE 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
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Condition  ICMJE Healthy Volunteers
Intervention  ICMJE
  • Drug: PF-04308515
    Oral solution/suspension 0.1 mg up to potentially 350 mg QD at a single dose.
  • Drug: Placebo
    Placebo solution/suspension to match active drug QD at a single dose.
Study Arms  ICMJE
  • Experimental: PF-04308515
    Intervention: Drug: PF-04308515
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 5, 2009)
27
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 2010
Actual Primary Completion Date January 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00990015
Other Study ID Numbers  ICMJE B0861001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date January 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP