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Multiple Dose Escalation Trial Of PF-04308515 In Healthy Volunteers

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT01101932
First received: March 11, 2010
Last updated: July 21, 2011
Last verified: July 2011

March 11, 2010
July 21, 2011
March 2010
November 2010   (final data collection date for primary outcome measure)
  • Safety and tolerability of multiple doses of PF-04308515 as assessed by adverse event reporting, clinical laboratory results, vital signs, physical examinations and electrocardiograms (ECGs). [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]
  • Characterization of pharmacokinetic parameters of PF-04308515 after multiples doses which will include: Cmax, Tmax, AUC, CL/F, Vz/F, t1/2. Urinary excretion including AE% and CLr will be assessed at steady state. [ Time Frame: 14 days ] [ Designated as safety issue: No ]
  • Change from baseline will be utilized to assess PF-04308515's pharmacodynamic effect on biochemical and metabolic biomarkers after 14 days of dosing. [ Time Frame: 14 days ] [ Designated as safety issue: No ]
  • For the tablet pharmacokinetics:Cmax, Tmax, AUClast, AUCinf, CL/F, Vz/F, t1/2 will be calculated from the PF-04308515 plasma concentration versus time data. [ Time Frame: 1 day ] [ Designated as safety issue: No ]
  • Safety and tolerability of 1 oral dose of a tablet formulation of PF-04308515 as assessed by adverse event reporting, clinical laboratory results, vital signs, physical examinations and electrocardiograms (ECGs). [ Time Frame: 1 day ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01101932 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Multiple Dose Escalation Trial Of PF-04308515 In Healthy Volunteers
A Phase 1, Placebo-Controlled, Multiple-Dose Escalation Trial Evaluating The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Of PF-04308515 (Part 1), And A Single Dose Pharmacokinetic Assessment Of A PF-04308515 Tablet Formulation (Part 2), In Healthy Volunteers

The purpose of this study is to determine the safety, tolerability, pharmacokinetics and pharmacodynamics (how the drug effects certain target sites of activity in the body) of escalating doses of oral PF-04308515 in healthy volunteers for 14 days as well as one oral dose of a tablet formulation administered for 1 day.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Healthy
  • Drug: PF-04308515
    PF-04308515 will be provided as an oral solution administered at doses of 3, 10, 30 and 100 mg. If an optional cohort is needed the dose would not exceed the established toxicokinetic exposure limits. Solution will be administered orally once daily for 14 days.
  • Drug: Placebo
    Placebo solution will be administered to those volunteers who are randomized to the placebo arm. Placebo solution will be administered orally once daily for 14 days.
  • Drug: PF-04308515 Tablet
    Tablet formulation to administer a 20 mg dose will be administered to volunteers in Part 2. The study medication will be administered orally once daily for 1 day.
  • Experimental: (Part 1) PF-04308515
    Intervention: Drug: PF-04308515
  • Placebo Comparator: (Part 1) Solution Placebo
    Intervention: Drug: Placebo
  • Experimental: (Part 2) PF-04308515 Tablet
    Intervention: Drug: PF-04308515 Tablet
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
58
November 2010
November 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Healthy males between 18 and 55 years, inclusive
  • Healthy females between 18 and 44 years, inclusive
  • Females are required to be surgically sterile

Exclusion Criteria:

  • Evidence or history of clinically significant disease
  • Post-menopausal women
  • History of intolerance or significant adverse effects with glucocorticoid therapy
Both
18 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01101932
B0861002
No
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
July 2011

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