An Investigational Study of Experimental Medication BMS-986165 in Healthy Participants

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 1

Conditions: Healthy Participants

Treatments: Drug: MMF; Drug: BMS-986165

Study type: Interventional

Funder types: Industry

Identifiers

NCT03660436

IM011-071

Details and patient eligibility

About

The purpose of this study is to investigate the effects of experimental medication BMS-986165 in healthy male participants.

Enrollment: 131 patients

Sex: Male

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

• Healthy participant, as determined by no clinically significant deviation from normal in physical examination, electrocardiograms (ECGs), and clinical laboratory determinations
• Body mass index of 18.0 to 32.0 kg/m2, inclusive, and weight ≥ 50 kg, at screening
• Normal renal function at screening as evidenced by an estimated GFR (glomerular filtration rate) > 80 mL/min/1.732 m2

Exclusion Criteria:

• Any medical condition that presents a potential risk to the participant and/or may compromise the objectives of the study, including a history of or active liver disease
• Positive anti- John Cunningham virus (JCV) antibody test at Screening
• History of allergy to MMF, BMS-986165, related compounds or any significant drug allergy

Other protocol defined inclusion/exclusion criteria could apply

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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131 participants in 1 patient group

BMS-986165 + MMF

Experimental group

Description:

Oral administration

Treatment:

Drug: MMF

Drug: BMS-986165