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Trial record 1 of 1 for:    NCT02767089
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The Dose Response of Prednisone on Biochemical and Clinical Makers in Adult Healthy Volunteers

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ClinicalTrials.gov Identifier: NCT02767089
Recruitment Status : Completed
First Posted : May 10, 2016
Last Update Posted : May 10, 2016
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE April 21, 2016
First Posted Date  ICMJE May 10, 2016
Last Update Posted Date May 10, 2016
Study Start Date  ICMJE October 2005
Actual Primary Completion Date March 2006   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 6, 2016)
  • Characterize the dose-response effect of prednisone 2.5, 5, 10, 20, 40 and 60 mg on osteocalcin [ Time Frame: 8 days ]
    The change in serum osteocalcin from baseline after treatment on Day 1 and Day 8 will be assessed in each treatment period
  • Characterize the dose-response effect of prednisone 2.5, 5, 10, 20, 40 and 60 mg on Cortisol Suppression [ Time Frame: 8 days ]
    Change from baseline in serum cortisol after treatment on Day 1 and Day 8 in each treatment period
  • Characterize the dose-response effect of prednisone 2.5, 5, 10, 20, 40 and 60 mg on HPA Axis Suppression [ Time Frame: 14 days after the last study visit in Period 3, if repeat testing required will be done 28 days after first test ]
    Serum cortisol in response to low-dose ACTH Stimulation Test will be completed at the end of Period 3 for each subject
  • Characterize the dose-response effect of prednisone 2.5, 5, 10, 20, 40 and 60 mg on White Blood Cell Counts [ Time Frame: 8 days ]
    Change from baseline in blood leukocytes (neutrophils, lymphocytes and eosinophils) in each treatment period
  • Characterize the dose-response effect of prednisone 2.5, 5, 10, 20, 40 and 60 mg on Procollagen type 1-N-Propeptide (P1NP) [ Time Frame: 8 days ]
    The change from baseline in serum P1NP after treatment on Day 1 and Day 8 will be assessed in each treatment period
  • Characterize the dose-response effect of prednisone 2.5, 5, 10, 20, 40 and 60 mg on Urinary N-terminal cross-linked telopeptide of type 1 collagen (uNTX-1) [ Time Frame: 8 days ]
    Change from baseline in uNTX-1 will be assessed on Day 1 and Day 8 after treatment in each treatment period
  • Characterize the dose-response effect of prednisone 2.5, 5, 10, 20, 40 and 60 mg on Fasting glucose and insulin [ Time Frame: 8 days ]
    Glucose and insulin will be assessed for the change from baseline after 7 days of treatment on Day 8 in each treatment period
  • Characterize the dose-response effect of prednisone 2.5, 5, 10, 20, 40 and 60 mg on an Oral Glucose Tolerance Test [ Time Frame: Day 6 ]
    On Day 6 of each period, subjects will undergo an oral glucose tolerance test. After ingesting 75 g of a glucose solution within 5 minutes of receiving their daily dose of prednisone, blood samples for glucose were obtained at 0.5, 1 and 2 hours.
  • Characterize the dose-response effect of prednisone 2.5, 5, 10, 20, 40 and 60 mg on Triglycerides [ Time Frame: 8 days ]
    Change from baseline in triglycerides will be assessed after 7 days of treatment on Day 8 in each treatment period
  • Characterize the dose-response effect of prednisone 2.5, 5, 10, 20, 40 and 60 mg on Urinary Cortisol Suppression [ Time Frame: 7 days ]
    Change from baseline in 24-hour urinary cortisol on Day 7 in each treatment period
  • Characterize the dose-response effect of prednisone 2.5, 5, 10, 20, 40 and 60 mg on Adiponectin [ Time Frame: 8 days ]
    Change from baseline in adiponectin will be assessed after 7 days of treatment on Day 8 in each treatment period
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: May 6, 2016)
  • Characterize the dose-response effect of prednisone 2.5, 5, 10, 20, 40 and 60 mg on Profile of Mood State [ Time Frame: 7 days ]
    Change from baseline after 7 days of treatment in each treatment period. The POMS is a copyrighted questionnaire that measures 6 dimensions of mood. The subject will assess how 65 descriptors apply to him/her on a 5-point scale of 0 (not at all) to 4 (extremely).
  • Characterize the dose-response effect of prednisone 2.5, 5, 10, 20, 40 and 60 mg on Medical Outcomes: Sleep Scale (MOS-Sleep) [ Time Frame: 7 days ]
    Change from baseline in sleep after 7 days of treatment will be assessed in each treatment period. The patient-reported questionnaire consists of 12 items that assesses the key constructs of sleep. Scores can range from 12-71 with higher number indicating more problems with sleep.
  • Characterize the dose-response effect of prednisone 2.5, 5, 10, 20, 40 and 60 mg on the Incidence of Adverse Events [ Time Frame: 28 days after last dose of study medication in Period 3 ]
    Subjects were monitored throughout the study and queried for adverse events
  • Characterize the dose-response effect of prednisone 2.5, 5, 10, 20, 40 and 60 mg on Blood Pressure [ Time Frame: 8 days ]
    Blood pressure will be assessed for change from baseline after 7 days of treatment on Day 8 in each treatment period
  • Characterize the dose-response effect of prednisone 2.5, 5, 10, 20, 40 and 60 mg on Weight [ Time Frame: 8 days ]
    A post-void weight will be collected on the morning of Day 1 and Day 8 to assess change from baseline during each treatment period.
  • Characterize the dose-response effect of prednisone 2.5, 5, 10, 20, 40 and 60 mg on pulse rate [ Time Frame: 8 days ]
    Pulse rate will be assessed for change from baseline after 7 days of treatment on Day 8 in each treatment period
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
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