A Study of Pharmacokinetics (PK) and Pharmacodynamics (PD) in Relation to Prednisolone in Healthy Males

Phase 1CompletedNCT03198013

Bristol-Myers Squibb120 enrolled

Overview

The purpose of this study is to evaluate the safety, PK, PD, of BMS-791826 and to assess its marker specific PD in relation to Prednisolone in healthy male subjects

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

DOUBLE

Enrollment

120

Conditions

Immunoscience

Interventions

PrednisoloneDRUG

Specified dose on specified days

BMS-791826DRUG

Specified dose on specified days

PlaceboDRUG

Specified dose on specified days

Eligibility

Sex: MALEMin age: 18 YearsMax age: 55 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Healthy male subjects as determined by no clinically significant deviation from normal in medical history, physical examination, electrocardiograms (ECGs), and clinical laboratory determinations * Body Mass Index (BMI) of 18 to 30 kilogram / square meter (kg/m2), inclusive * Signed informed consent Exclusion Criteria: * Sexually active fertile men not using effective birth control (barrier contraception) if their partners are women of childbearing potential (WOCBP) * Any significant acute or chronic medical illness * History of Gilbert's disease Other protocol inclusion/exclusion criteria may apply

Locations (1)

Local Institution

Melbourne, Victoria, Australia

Outcomes

Primary Outcomes

Incidence of Adverse Events (AEs)

safety and tolerability

Time frame: Up to 34 days

Incidence of serious adverse events (SAEs)

safety and tolerability

Time frame: Up to 34 days

Data from ClinicalTrials.gov

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