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

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 1

Conditions: Immunoscience

Treatments: Drug: Prenisolone; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03196557

IM124-001

Details and patient eligibility

About

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

Enrollment: 24 patients

Sex: Male

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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24 participants in 2 patient groups, including a placebo group

Arm A

Experimental group

Description:

Specified dose on specified days

Treatment:

Drug: Prenisolone

Arm B

Placebo Comparator group

Description:

Specified dose on specified days

Treatment:

Drug: Placebo