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

Phase 1

Completed

• Conditions: Healthy Adults
• Interventions: Drug: Prednisone; Drug: Placebo

• Registration Number: NCT02767089
• Lead Sponsor: Pfizer

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 available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2005-10
• Primary Completion: 2006-03
• Study Completion: 2006-03
• Study First Submitted: 2016-04-21
• Status Verified: 2016-05
• Study First Submitted QC: 2016-05-06
• Last Update Submitted: 2016-05-06
• Study First Posted: 2016-05-10
• Last Update Posted: 2016-05-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 37

Inclusion Criteria

• Healthy male or females willing to be confined and comply with scheduled visits
• Women are to be surgically sterile.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Sequence E	Placebo	Period 1: Prednisone 20 mg Period 2: Prednisone 40 mg Period 3: Placebo
Sequence A	Prednisone	Period 1: Placebo Period 2: Prednisone 2.5 mg Period 3: Prednisone 10 mg
Sequence G	Placebo	Period 1: Prednisone 60 mg Period 2: Placebo Period 3: Prednisone 5 mg
Sequence A	Placebo	Period 1: Placebo Period 2: Prednisone 2.5 mg Period 3: Prednisone 10 mg
Sequence B	Prednisone	Period 1: Prednisone 2.5 mg Period 2: Prednisone 5 mg Period 3: Prednisone 20 mg
Sequence C	Prednisone	Period 1: Prednisone 5 mg Period 2: Prednisone 10 mg Period 3: Prednisone 40 mg
Sequence D	Prednisone	Period 1: Prednisone 10 mg Period 2: Prednisone 20 mg Period 3: Prednisone 60 mg
Sequence E	Prednisone	Period 1: Prednisone 20 mg Period 2: Prednisone 40 mg Period 3: Placebo
Sequence F	Prednisone	Period 1: Prednisone 40 mg Period 2: Prednisone 60 mg Period 3: Prednisone 2.5 mg
Sequence G	Prednisone	Period 1: Prednisone 60 mg Period 2: Placebo Period 3: Prednisone 5 mg

Primary Outcome Measures

Name	Time	Method
Characterize the dose-response effect of prednisone 2.5, 5, 10, 20, 40 and 60 mg on Cortisol Suppression	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 osteocalcin	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 Procollagen type 1-N-Propeptide (P1NP)	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 Triglycerides	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 Adiponectin	8 days	Change from baseline in adiponectin 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 White Blood Cell Counts	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 an Oral Glucose Tolerance Test	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 HPA Axis Suppression	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 Fasting glucose and insulin	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 Urinary Cortisol Suppression	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 Urinary N-terminal cross-linked telopeptide of type 1 collagen (uNTX-1)	8 days	Change from baseline in uNTX-1 will be assessed on Day 1 and Day 8 after treatment in each treatment period

Secondary Outcome Measures

Name	Time	Method
Characterize the dose-response effect of prednisone 2.5, 5, 10, 20, 40 and 60 mg on the Incidence of Adverse Events	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	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 Medical Outcomes: Sleep Scale (MOS-Sleep)	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 pulse rate	8 days	Pulse rate 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	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 Profile of Mood State	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).

Trial Locations

Locations (1)

Jasper Clinic, Inc.; 🇺🇸 Kalamazoo, Michigan, United States