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

An Open-Label, Single-Sequence Study to Investigate the Effects of BMS-986165 on the Single-Dose Pharmacokinetics of Methotrexate in Healthy Male Subjects

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03402087
Enrollment
30
Registered
2018-01-18
Start date
2018-01-08
Completion date
2018-03-25
Last updated
2020-02-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lupus, Psoriatic Arthritis

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.

Interventions

DRUGMethotrexate

Specified dose on specified days

DRUGLeucovorin

Specified dose on specified days

DRUGBMS-986165

Specified dose on specified days

Sponsors

Bristol-Myers Squibb
Lead SponsorINDUSTRY

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
18 Years to 50 Years
Healthy volunteers
Yes

Inclusion 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/

Design outcomes

Primary

MeasureTime frame
Apparent oral clearance (CL/F)Approximately 14 days
Terminal elimination rate constant (kel)Approximately 14 days
Terminal elimination half life, calculated as 0.693/kel (T-HALF)Approximately 14 days
Maximum observed plasma concentration (Cmax)Approximately 14 days
Time to attain maximum observed plasma concentration (Tmax)Approximately 14 days
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)]Approximately 14 days
Area under the plasma concentration-time curve from time 0 to infinity [AUC(INF)]Approximately 14 days

Secondary

MeasureTime frame
Incidence of serious adverse events (SAEs)Approximately 19 days
Incidence of adverse events (AEs)Approximately 19 days

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026