An Open-Label, Single-Sequence Study to Investigate the Effects of BMS-986165 on the Single-Dose Pharmacokinetics of Methotrexate in Healthy Male Subjects
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Maximum observed plasma concentration (Cmax)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 50 Years (Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
BMS-986165+Methotrexate+Leucovorin
Three treatments administered
Intervention: Methotrexate (Drug)
BMS-986165+Methotrexate+Leucovorin
Three treatments administered
Intervention: Leucovorin (Drug)
BMS-986165+Methotrexate+Leucovorin
Three treatments administered
Intervention: BMS-986165 (Drug)
Outcomes
Primary Outcomes
Maximum observed plasma concentration (Cmax)
Time Frame: Approximately 14 days
Time to attain maximum observed plasma concentration (Tmax)
Time Frame: 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)]
Time Frame: Approximately 14 days
Area under the plasma concentration-time curve from time 0 to infinity [AUC(INF)]
Time Frame: Approximately 14 days
Terminal elimination rate constant (kel)
Time Frame: Approximately 14 days
Terminal elimination half life, calculated as 0.693/kel (T-HALF)
Time Frame: Approximately 14 days
Apparent oral clearance (CL/F)
Time Frame: Approximately 14 days
Secondary Outcomes
- Incidence of serious adverse events (SAEs)(Approximately 19 days)
- Incidence of adverse events (AEs)(Approximately 19 days)