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
1 other identifier
interventional
24
1 country
2
Brief Summary
The purpose of this study is to assess the pharmacodynamics of Prednisolone in healthy male subjects
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Mar 2008
Shorter than P25 for phase_1
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 31, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 5, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
May 5, 2008
CompletedFirst Submitted
Initial submission to the registry
June 21, 2017
CompletedFirst Posted
Study publicly available on registry
June 22, 2017
CompletedDecember 6, 2019
December 1, 2019
1 month
June 21, 2017
December 4, 2019
Conditions
Outcome Measures
Primary Outcomes (18)
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
Study Arms (2)
Arm A
EXPERIMENTALSpecified dose on specified days
Arm B
PLACEBO COMPARATORSpecified dose on specified days
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Women
- Any significant acute or chronic medical illness
- Current or recent (within 3 months) gastrointestinal disease including peptic ulcer
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Ppd Development
Austin, Texas, 78744, United States
Local Institution
Austin, Texas, 78759, United States
Related Publications (1)
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.
PMID: 29534336DERIVED
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 21, 2017
First Posted
June 22, 2017
Study Start
March 31, 2008
Primary Completion
May 5, 2008
Study Completion
May 5, 2008
Last Updated
December 6, 2019
Record last verified: 2019-12