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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence A | Other | Period 1: Placebo Period 2: Prednisone 2.5 mg Period 3: Prednisone 10 mg |
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| Sequence B | Other | Period 1: Prednisone 2.5 mg Period 2: Prednisone 5 mg Period 3: Prednisone 20 mg |
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| Sequence C | Other | Period 1: Prednisone 5 mg Period 2: Prednisone 10 mg Period 3: Prednisone 40 mg |
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| Sequence D | Other | Period 1: Prednisone 10 mg Period 2: Prednisone 20 mg Period 3: Prednisone 60 mg |
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| Sequence E | Other | Period 1: Prednisone 20 mg Period 2: Prednisone 40 mg Period 3: Placebo |
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| Sequence F | Other | Period 1: Prednisone 40 mg Period 2: Prednisone 60 mg Period 3: Prednisone 2.5 mg |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prednisone | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 | 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 | 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 | 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 | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 7 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jasper Clinic, Inc. | Kalamazoo | Michigan | 49007 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27424036 | Derived | 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. |
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| ID | Term |
|---|---|
| D011241 | Prednisone |
| ID | Term |
|---|---|
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 |
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|
| Sequence G | Other | Period 1: Prednisone 60 mg Period 2: Placebo Period 3: Prednisone 5 mg |
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| Placebo | Drug | Placebo tablets similar to Prednisone 2.5 mg and 20 mg were supplied to make the trial doses. |
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| 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 | 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. | 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 | 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 | 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 | 8 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. | 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 | 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 | 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. | 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 | 8 days |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |