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The Dose Response of Prednisone on Biochemical and Clinical Makers in Adult Healthy Volunteers

Last updated on December 11, 2019

FOR MORE INFORMATION
Study Location
Jasper Clinic, Inc.
Kalamazoo, Michigan, 49007 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy Adults
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 male or females willing to be confined and comply with scheduled visits

- Women are to be surgically sterile.

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

- History of febrile illness within 5 days prior to the first dose

- Positive urine drug screen

- Treatment with an investigational product within 30 days prior to the first dose of
study medication

NCT02767089
Pfizer
Completed
The Dose Response of Prednisone on Biochemical and Clinical Makers in Adult Healthy Volunteers

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Descriptive Information
Brief Title  ICMJE The Dose Response of Prednisone on Biochemical and Clinical Makers in Adult Healthy Volunteers
Official Title  ICMJE A Randomized, Single-blind, Placebo-controlled, Crossover Studyto Assess The Dose Response Of Prednisone On Biochemical Andclinical Markers Of Efficacy And Safety In Adult Healthyvolunteers
Brief Summary The purpose of this study is to further access the utility of biochemical and clinical biomarkers for glucocorticoid-mediated anti-inflammatory effects and safety endpoints against which dissociated agonists of the glucocorticoid receptor (DAGR) will be evaluated in adult healthy volunteers.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single
Condition  ICMJE Healthy Adults
Intervention  ICMJE
  • Drug: Prednisone
    Subjects will receive oral prednisone and/or placebo tablets (total of 4 tablets) to achieve the required dose according to the treatment sequence group they were randomized. Subjects are to be dosed each morning for 7 days. A 14 day washout period is required between each period. Prednisone was supplied in the 2.5 and 20 mg dosage strengths.
  • Drug: Placebo
    Placebo tablets similar to Prednisone 2.5 mg and 20 mg were supplied to make the trial doses.
Study Arms  ICMJE
  • Sequence A
    Period 1: Placebo Period 2: Prednisone 2.5 mg Period 3: Prednisone 10 mg
    Interventions:
    • Drug: Prednisone
    • Drug: Placebo
  • Sequence B
    Period 1: Prednisone 2.5 mg Period 2: Prednisone 5 mg Period 3: Prednisone 20 mg
    Intervention: Drug: Prednisone
  • Sequence C
    Period 1: Prednisone 5 mg Period 2: Prednisone 10 mg Period 3: Prednisone 40 mg
    Intervention: Drug: Prednisone
  • Sequence D
    Period 1: Prednisone 10 mg Period 2: Prednisone 20 mg Period 3: Prednisone 60 mg
    Intervention: Drug: Prednisone
  • Sequence E
    Period 1: Prednisone 20 mg Period 2: Prednisone 40 mg Period 3: Placebo
    Interventions:
    • Drug: Prednisone
    • Drug: Placebo
  • Sequence F
    Period 1: Prednisone 40 mg Period 2: Prednisone 60 mg Period 3: Prednisone 2.5 mg
    Intervention: Drug: Prednisone
  • Sequence G
    Period 1: Prednisone 60 mg Period 2: Placebo Period 3: Prednisone 5 mg
    Interventions:
    • Drug: Prednisone
    • Drug: Placebo
Publications * Fleishaker DL, Mukherjee A, Whaley FS, Daniel S, Zeiher BG. Safety and pharmacodynamic dose response of short-term prednisone in healthy adult subjects: a dose ranging, randomized, placebo-controlled, crossover study. BMC Musculoskelet Disord. 2016 Jul 16;17:293. doi: 10.1186/s12891-016-1135-3.


*   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: May 6, 2016)
37
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2006
Actual Primary Completion Date March 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy male or females willing to be confined and comply with scheduled visits
  • Women are to be surgically sterile.

Exclusion Criteria:

  • History of febrile illness within 5 days prior to the first dose
  • Positive urine drug screen
  • Treatment with an investigational product within 30 days prior to the first dose of study medication
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 NCT02767089
Other Study ID Numbers  ICMJE A9001309
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date May 2016

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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