Clinical trial NCT02767089: The Dose Response of Prednisone on Biochemical and Clinical Makers in Adult Healthy Volunteers
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Adults
Keywords: Glucocorticoids, Biomarkers, Dissociated Agonist of the Glucocorticoid Receptor
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2016-05-10
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

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.


Eligibility criteria: 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

Primary outcomes:
measure: Characterize the dose-response effect of prednisone 2.5, 5, 10, 20, 40 and 60 mg on osteocalcin
timeFrame: 8 days
measure: Characterize the dose-response effect of prednisone 2.5, 5, 10, 20, 40 and 60 mg on Cortisol Suppression
timeFrame: 8 days
measure: Characterize the dose-response effect of prednisone 2.5, 5, 10, 20, 40 and 60 mg on HPA Axis Suppression
timeFrame: 14 days after the last study visit in Period 3, if repeat testing required will be done 28 days after first test
measure: Characterize the dose-response effect of prednisone 2.5, 5, 10, 20, 40 and 60 mg on White Blood Cell Counts
timeFrame: 8 days
measure: Characterize the dose-response effect of prednisone 2.5, 5, 10, 20, 40 and 60 mg on Procollagen type 1-N-Propeptide (P1NP)
timeFrame: 8 days
measure: 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)
timeFrame: 8 days
measure: Characterize the dose-response effect of prednisone 2.5, 5, 10, 20, 40 and 60 mg on Fasting glucose and insulin
timeFrame: 8 days
measure: Characterize the dose-response effect of prednisone 2.5, 5, 10, 20, 40 and 60 mg on an Oral Glucose Tolerance Test
timeFrame: Day 6
measure: Characterize the dose-response effect of prednisone 2.5, 5, 10, 20, 40 and 60 mg on Triglycerides
timeFrame: 8 days
measure: Characterize the dose-response effect of prednisone 2.5, 5, 10, 20, 40 and 60 mg on Urinary Cortisol Suppression
timeFrame: 7 days
measure: Characterize the dose-response effect of prednisone 2.5, 5, 10, 20, 40 and 60 mg on Adiponectin
timeFrame: 8 days
Secondary outcomes:
measure: Characterize the dose-response effect of prednisone 2.5, 5, 10, 20, 40 and 60 mg on Profile of Mood State
timeFrame: 7 days
measure: Characterize the dose-response effect of prednisone 2.5, 5, 10, 20, 40 and 60 mg on Medical Outcomes: Sleep Scale (MOS-Sleep)
timeFrame: 7 days
measure: Characterize the dose-response effect of prednisone 2.5, 5, 10, 20, 40 and 60 mg on the Incidence of Adverse Events
timeFrame: 28 days after last dose of study medication in Period 3
measure: Characterize the dose-response effect of prednisone 2.5, 5, 10, 20, 40 and 60 mg on Blood Pressure
timeFrame: 8 days
measure: Characterize the dose-response effect of prednisone 2.5, 5, 10, 20, 40 and 60 mg on Weight
timeFrame: 8 days
measure: Characterize the dose-response effect of prednisone 2.5, 5, 10, 20, 40 and 60 mg on pulse rate
timeFrame: 8 days
Other outcomes:
Locations:
city: Kalamazoo
country: United States
facility: Jasper Clinic, Inc.
state: Michigan
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: 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.