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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03402087
Recruitment Status : Completed
First Posted : January 18, 2018
Last Update Posted : February 25, 2020
Information provided by (Responsible Party):
Bristol-Myers Squibb

Brief 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.

Condition or disease Intervention/treatment Phase
Lupus Psoriatic Arthritis Drug: Methotrexate Drug: Leucovorin Drug: BMS-986165 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label, Single-Sequence Study to Investigate the Effects of BMS-986165 on the Single-Dose Pharmacokinetics of Methotrexate in Healthy Male Subjects
Actual Study Start Date : January 8, 2018
Actual Primary Completion Date : March 20, 2018
Actual Study Completion Date : March 25, 2018

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: BMS-986165+Methotrexate+Leucovorin
Three treatments administered
Drug: Methotrexate
Specified dose on specified days
Other Name: MTX

Drug: Leucovorin
Specified dose on specified days
Other Name: LEU

Drug: BMS-986165
Specified dose on specified days

Primary Outcome Measures :
  1. Maximum observed plasma concentration (Cmax) [ Time Frame: Approximately 14 days ]
  2. Time to attain maximum observed plasma concentration (Tmax) [ Time Frame: Approximately 14 days ]
  3. Area under the plasma concentration-time curve up to time T, where T is the last point with concentrations above the lower limit of quantitation [AUC(0-T)] [ Time Frame: Approximately 14 days ]
  4. Area under the plasma concentration-time curve from time 0 to infinity [AUC(INF)] [ Time Frame: Approximately 14 days ]
  5. Terminal elimination rate constant (kel) [ Time Frame: Approximately 14 days ]
  6. Terminal elimination half life, calculated as 0.693/kel (T-HALF) [ Time Frame: Approximately 14 days ]
  7. Apparent oral clearance (CL/F) [ Time Frame: Approximately 14 days ]

Secondary Outcome Measures :
  1. Incidence of adverse events (AEs) [ Time Frame: Approximately 19 days ]
  2. Incidence of serious adverse events (SAEs) [ Time Frame: Approximately 19 days ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03402087

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PRA Health Sciences
Groningen, Netherlands, 9728 NZ
Sponsors and Collaborators
Bristol-Myers Squibb
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Additional Information:
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Responsible Party: Bristol-Myers Squibb Identifier: NCT03402087    
Other Study ID Numbers: IM011-025
2017-004177-13 ( EudraCT Number )
First Posted: January 18, 2018    Key Record Dates
Last Update Posted: February 25, 2020
Last Verified: February 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Arthritis, Psoriatic
Joint Diseases
Musculoskeletal Diseases
Spinal Diseases
Bone Diseases
Skin Diseases, Papulosquamous
Skin Diseases
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors