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Multiple Dose Escalation Trial Of PF-04308515 In Healthy Volunteers

Last updated on May 10, 2018

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Study Location
Pfizer Investigational Site
New Haven, Connecticut, 06511 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-55 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Evidence or history of clinically significant disease

- Post-menopausal women

- History of intolerance or significant adverse effects with glucocorticoid therapy

NCT01101932
Pfizer
Completed
Multiple Dose Escalation Trial Of PF-04308515 In Healthy Volunteers

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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
Intervention Model: Single Group Assignment
Masking: Double (Participant, 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
Sexes Eligible for Study: All
18 Years to 55 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01101932
B0861002
No
Not Provided
Not Provided
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

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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Pfizer Clinical Trials Contact Center

1-800-718-1021

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Contact

[email protected]



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