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

Phase 1

Completed

• Conditions: Immunoscience
• Interventions: Drug: Prenisolone; Drug: Placebo

• Registration Number: NCT03196557
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2008-03-31
• Primary Completion: 2008-05-05
• Study Completion: 2008-05-05
• Study First Submitted: 2017-06-21
• Study First Submitted QC: 2017-06-21
• Study First Posted: 2017-06-22
• Status Verified: 2019-12
• Last Update Submitted: 2019-12-04
• Last Update Posted: 2019-12-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 24

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm A	Prenisolone	Specified dose on specified days
Arm B	Placebo	Specified dose on specified days

Primary Outcome Measures

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

Trial Locations

Locations (2)

Ppd Development; 🇺🇸 Austin, Texas, United States

Local Institution; 🇺🇸 Austin, Texas, United States