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

Last updated on March 22, 2018

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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The Dose Response of Prednisone on Biochemical and Clinical Makers in Adult Healthy Volunteers
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
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.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single
Healthy Adults
  • 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.
  • 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
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.
 
Completed
37
March 2006
March 2006   (Final data collection date for primary outcome measure)

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
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
 
 
NCT02767089
A9001309
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
May 2016

ICMJE     Data element required by the

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

FOR MORE INFORMATION

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