A Study to Investigate BMS-986165 and Methotrexate in Healthy Male Patients

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 1

Conditions: Lupus; Psoriatic Arthritis

Treatments: Drug: BMS-986165; Drug: Methotrexate; Drug: Leucovorin

Study type: Interventional

Funder types: Industry

Identifiers

NCT03402087

IM011-025

2017-004177-13 (EudraCT Number)

Details and patient eligibility

About

The purpose of this study is to investigate effects of BMS-986165 on blood levels of methotrexate given as a single dose in healthy male patients.

Enrollment: 30 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:

• Body Mass Index (BMI): 18.0 - 32.0 kg/m2
• Normal renal function at screening

Exclusion Criteria:

• Any medical condition that presents a potential risk to the participant and/or that may compromise the objectives of the study, including active, or history of, liver disease
• Any contraindication indicated in the MTX package insert
• History or presence of chronic bacterial or viral infection
• History or presence of an autoimmune disorder
• Any significant acute or chronic medical illness
• Active TB requiring treatment or documented latent TB within the previous 3 years
• Current or recent (within 3 months of study treatment administration) gastrointestinal disease that could affect absorption

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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30 participants in 1 patient group

BMS-986165+Methotrexate+Leucovorin

Experimental group

Description:

Three treatments administered

Treatment:

Drug: Leucovorin

Drug: BMS-986165

Drug: Methotrexate