A Phase 1 interventional study of Prednisone and Placebo in Healthy Adults, sponsored by Pfizer. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-05-10.
Sponsored by Pfizer · Phase 1 and Interventional
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.
Pfizer is the lead sponsor of 3,244 studies on the registry; 139 are open to participants now.
Of its 582 completed or terminated interventional studies of FDA-regulated products, 381 (65%) have results posted.
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Period 1: Placebo Period 2: Prednisone 2.5 mg Period 3: Prednisone 10 mg
Drug: Prednisone · Drug: Placebo
Period 1: Prednisone 2.5 mg Period 2: Prednisone 5 mg Period 3: Prednisone 20 mg
Drug: Prednisone
Period 1: Prednisone 5 mg Period 2: Prednisone 10 mg Period 3: Prednisone 40 mg
Drug: Prednisone
Period 1: Prednisone 10 mg Period 2: Prednisone 20 mg Period 3: Prednisone 60 mg
Drug: Prednisone
Period 1: Prednisone 20 mg Period 2: Prednisone 40 mg Period 3: Placebo
Drug: Prednisone · Drug: Placebo
Period 1: Prednisone 40 mg Period 2: Prednisone 60 mg Period 3: Prednisone 2.5 mg
Drug: Prednisone
Period 1: Prednisone 60 mg Period 2: Placebo Period 3: Prednisone 5 mg
Drug: Prednisone · Drug: Placebo
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.
Placebo tablets similar to Prednisone 2.5 mg and 20 mg were supplied to make the trial doses.
Characterize the dose-response effect of prednisone 2.5, 5, 10, 20, 40 and 60 mg on osteocalcin
The change in serum osteocalcin from baseline after treatment on Day 1 and Day 8 will be assessed in each treatment period
Time frame: 8 days
Characterize the dose-response effect of prednisone 2.5, 5, 10, 20, 40 and 60 mg on Cortisol Suppression
Change from baseline in serum cortisol after treatment on Day 1 and Day 8 in each treatment period
Time frame: 8 days
Characterize the dose-response effect of prednisone 2.5, 5, 10, 20, 40 and 60 mg on HPA Axis Suppression
Serum cortisol in response to low-dose ACTH Stimulation Test will be completed at the end of Period 3 for each subject
Time frame: 14 days after the last study visit in Period 3, if repeat testing required will be done 28 days after first test
Characterize the dose-response effect of prednisone 2.5, 5, 10, 20, 40 and 60 mg on White Blood Cell Counts
Change from baseline in blood leukocytes (neutrophils, lymphocytes and eosinophils) in each treatment period
Time frame: 8 days
Characterize the dose-response effect of prednisone 2.5, 5, 10, 20, 40 and 60 mg on Procollagen type 1-N-Propeptide (P1NP)
The change from baseline in serum P1NP after treatment on Day 1 and Day 8 will be assessed in each treatment period
Time frame: 8 days
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)
Change from baseline in uNTX-1 will be assessed on Day 1 and Day 8 after treatment in each treatment period
Time frame: 8 days
Characterize the dose-response effect of prednisone 2.5, 5, 10, 20, 40 and 60 mg on Fasting glucose and insulin
Glucose and insulin will be assessed for the change from baseline after 7 days of treatment on Day 8 in each treatment period
Time frame: 8 days
Characterize the dose-response effect of prednisone 2.5, 5, 10, 20, 40 and 60 mg on an Oral Glucose Tolerance Test
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.
Time frame: Day 6
Characterize the dose-response effect of prednisone 2.5, 5, 10, 20, 40 and 60 mg on Triglycerides
Change from baseline in triglycerides will be assessed after 7 days of treatment on Day 8 in each treatment period
Time frame: 8 days
Characterize the dose-response effect of prednisone 2.5, 5, 10, 20, 40 and 60 mg on Urinary Cortisol Suppression
Change from baseline in 24-hour urinary cortisol on Day 7 in each treatment period
Time frame: 7 days
Characterize the dose-response effect of prednisone 2.5, 5, 10, 20, 40 and 60 mg on Adiponectin
Change from baseline in adiponectin will be assessed after 7 days of treatment on Day 8 in each treatment period
Time frame: 8 days
Characterize the dose-response effect of prednisone 2.5, 5, 10, 20, 40 and 60 mg on Profile of Mood State
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).
Time frame: 7 days
Characterize the dose-response effect of prednisone 2.5, 5, 10, 20, 40 and 60 mg on Medical Outcomes: Sleep Scale (MOS-Sleep)
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.
Time frame: 7 days
Characterize the dose-response effect of prednisone 2.5, 5, 10, 20, 40 and 60 mg on the Incidence of Adverse Events
Subjects were monitored throughout the study and queried for adverse events
Time frame: 28 days after last dose of study medication in Period 3
Characterize the dose-response effect of prednisone 2.5, 5, 10, 20, 40 and 60 mg on Blood Pressure
Blood pressure will be assessed for change from baseline after 7 days of treatment on Day 8 in each treatment period
Time frame: 8 days
Characterize the dose-response effect of prednisone 2.5, 5, 10, 20, 40 and 60 mg on Weight
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.
Time frame: 8 days
Characterize the dose-response effect of prednisone 2.5, 5, 10, 20, 40 and 60 mg on pulse rate
Pulse rate will be assessed for change from baseline after 7 days of treatment on Day 8 in each treatment period
Time frame: 8 days
This study is completed, as verified in May 2016. You cannot join it, but the record below documents what was studied.
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