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Completed

NCT Number: NCT02767089

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

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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Key information

Conditions

Healthy Adults

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Jasper Clinic, Inc.

Kalamazoo, Michigan, 49007, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Placebo

Drug

Placebo tablets similar to Prednisone 2.5 mg and 20 mg were supplied to make the trial doses.

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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.

  9. 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

  10. 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

  11. 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

Secondary outcomes

  1. 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).

  2. 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.

  3. 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

  4. 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

  5. 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.

  6. 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

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study 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

Important dates

Study start
2005
Primary completion
2006
Study completion
2006
First posted
May 10, 2016
Registry last updated
May 10, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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