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

Immunoscience Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03196557
• Other study ID #: IM124-001
• Status: Completed
• Phase: Phase 1
• Start date: March 31, 2008
• Est. completion date: May 5, 2008

Study information

• Verified date: December 2019
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: May 5, 2008
• Est. primary completion date: May 5, 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Immunoscience

Intervention

Drug:
• Prenisolone
Specified dose on specified days
• Placebo
Specified dose on dose on specified days

Locations

Country	Name	City	State
United States	Local Institution	Austin	Texas
United States	Ppd Development	Austin	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

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