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

• Status: Completed
• Trial end date: 2018-03-25
• Target enrollment: 0
• Participant gender: Male

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Bristol-Myers Squibb
• Treatments: BMS-986165; Leucovorin; Methotrexate

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