A Study to Assess the Pharmacodynamics (PD) of Prednisoline in Healthy Male Subject

An Experimental Medicine Study to Assess the Pharmacodynamics Following Administration of Multiple Doses of Prednisolone to Healthy Male Subjects

The purpose of this study is to assess the pharmacodynamics of Prednisolone in healthy male subjects

Study Overview

• Status: Completed
• Conditions: Immunoscience
• Intervention / Treatment: Drug: Prenisolone; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Texas
    • Austin, Texas, United States, 78744
      • Ppd Development
    • Austin, Texas, United States, 78759
      • Local Institution

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 53 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• Healthy male subjects as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations
• Body Mass Index (BMI) of 18 to 30 kilogram / square meter (kg/m2), inclusive
• Signed informed consent

Exclusion Criteria:

• Women
• Any significant acute or chronic medical illness
• Current or recent (within 3 months) gastrointestinal disease including peptic ulcer

Other protocol inclusion/exclusion criteria may apply

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm A; Specified dose on specified days	Drug: Prenisolone; Specified dose on specified days
Placebo Comparator: Arm B; Specified dose on specified days	Drug: Placebo; Specified dose on dose on specified days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Interleukin 1 beta	As measured by flow cytometry	Up to 32 days
Tumor necrosis factor-alpha	As measured by flow cytometry	Up to 32 days
Receptor activator of nuclear factor-kB (RANK)	As measured by flow cytometry	Up to 32 days
Receptor activator of nuclear factor-kB ligand (RANKL)	As measured by flow cytometry	Up to 32 days
Osteoprotegrin (OPG)	As measured by flow cytometry	Up to 32 days
Lipopolysaccharide Induced Cytokine Production	As measured by blood concentration	Up to 32 days
Cell Populations	As measured by flow cytometry	Up to 32 days
Oral glucose tolerance test	Assessed by central labortatory	Up to 32 days
Cortisol	As measured by the level of the hormone cortisol in the blood	Up to 32 days
Adrenocorticotropic hormone	As measured by the level of the hormone in the blood	Up to 32 days
Osteocalcin	As measured by blood concentration	Up to 32 days
N-terminal Pro-Collagen Peptide (PINP)	As measured by blood concentration	Up to 32 days
Propetide type I C-term Pro-collagen Peptide (CICP)	As measured by blood concentration	Up to 32 days
Bone-specific alkaline phosphatase	As measured by blood concentration	Up to 32 days
Urinary deoxypyridinoline	As measured by urine concentration	Up to 32 days
C Telopeptide of Collagen Type II (CTX-II)	As measured by urine concentration	Up to 32 days
Calcium	As measured by urine concentration	Up to 32 days
Creatinine	As measured by urine concentration	Up to 32 days

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb

Publications and helpful links

General Publications

• Hu Y, Carman JA, Holloway D, Kansal S, Fan L, Goldstine C, Lee D, Somerville JE, Latek R, Townsend R, Johnsen A, Connolly S, Bandyopadhyay S, Shadick N, Weinblatt ME, Furie R, Nadler SG. Development of a Molecular Signature to Monitor Pharmacodynamic Responses Mediated by In Vivo Administration of Glucocorticoids. Arthritis Rheumatol. 2018 Aug;70(8):1331-1342. doi: 10.1002/art.40476. Epub 2018 Jul 12.

Study record dates

Study Major Dates

• Study Start (Actual): March 31, 2008
• Primary Completion (Actual): May 5, 2008
• Study Completion (Actual): May 5, 2008

Study Registration Dates

• First Submitted: June 21, 2017
• First Submitted That Met QC Criteria: June 21, 2017
• First Posted (Actual): June 22, 2017

Study Record Updates

• Last Update Posted (Actual): December 6, 2019
• Last Update Submitted That Met QC Criteria: December 4, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: IM124-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No