Prenisolone
DrugSpecified dose on specified days
Completed
NCT Number: NCT03196557
A Study to Assess the Pharmacodynamics (PD) of Prednisoline in Healthy Male Subject
The purpose of this study is to assess the pharmacodynamics of Prednisolone in healthy male subjects
Completed
Looking for future studies?
Notify MeKey information
Conditions
Age range
18 year–55 year
Sex eligibility
Male
Study type
Interventional
Phase
Phase 1
Primary location
Local Institution, Austin, Texas, United States
Loading trial locations.
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Placebo
DrugSpecified dose on dose on specified days
Primary outcomes
-
Interleukin 1 beta
Time frame: Up to 32 days
As measured by flow cytometry
-
Tumor necrosis factor-alpha
Time frame: Up to 32 days
As measured by flow cytometry
-
Receptor activator of nuclear factor-kB (RANK)
Time frame: Up to 32 days
As measured by flow cytometry
-
Receptor activator of nuclear factor-kB ligand (RANKL)
Time frame: Up to 32 days
As measured by flow cytometry
-
Osteoprotegrin (OPG)
Time frame: Up to 32 days
As measured by flow cytometry
-
Lipopolysaccharide Induced Cytokine Production
Time frame: Up to 32 days
As measured by blood concentration
-
Cell Populations
Time frame: Up to 32 days
As measured by flow cytometry
-
Oral glucose tolerance test
Time frame: Up to 32 days
Assessed by central labortatory
-
Cortisol
Time frame: Up to 32 days
As measured by the level of the hormone cortisol in the blood
-
Adrenocorticotropic hormone
Time frame: Up to 32 days
As measured by the level of the hormone in the blood
-
Osteocalcin
Time frame: Up to 32 days
As measured by blood concentration
-
N-terminal Pro-Collagen Peptide (PINP)
Time frame: Up to 32 days
As measured by blood concentration
-
Propetide type I C-term Pro-collagen Peptide (CICP)
Time frame: Up to 32 days
As measured by blood concentration
-
Bone-specific alkaline phosphatase
Time frame: Up to 32 days
As measured by blood concentration
-
Urinary deoxypyridinoline
Time frame: Up to 32 days
As measured by urine concentration
-
C Telopeptide of Collagen Type II (CTX-II)
Time frame: Up to 32 days
As measured by urine concentration
-
Calcium
Time frame: Up to 32 days
As measured by urine concentration
-
Creatinine
Time frame: Up to 32 days
As measured by urine concentration
Sponsors and collaborators
Lead sponsor
Bristol-Myers Squibb
Industry
Registry information
Official study title
An Experimental Medicine Study to Assess the Pharmacodynamics Following Administration of Multiple Doses of Prednisolone to Healthy Male Subjects
Important dates
- Study start
- 2008
- Primary completion
- 2008
- Study completion
- 2008
- First posted
- Jun 22, 2017
- Registry last updated
- Dec 6, 2019
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.
Related clinical trials
Published trials that share one or more normalized conditions with this study.
Completed
A Study of Pharmacokinetics (PK) and Pharmacodynamics (PD) in Relation to Prednisolone in Healthy Males
NCT03198013
Immunoscience
Melbourne, Victoria, Australia
View Trial Details