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

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 1

Conditions: Immunoscience

Treatments: Drug: Placebo; Drug: BMS-791826; Drug: Prednisolone

Study type: Interventional

Funder types: Industry

Identifiers

NCT03198013

IM125-001

Details and patient eligibility

About

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

Enrollment: 120 patients

Sex: Male

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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120 participants in 2 patient groups

Module A

Experimental group

Description:

Single Ascending Dose

Treatment:

Drug: BMS-791826

Drug: Prednisolone

Drug: Placebo

Module B

Experimental group

Description:

Multiple Ascending Dose

Treatment:

Drug: BMS-791826

Drug: Prednisolone

Drug: Placebo