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
2 other identifiers
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Jan 2018
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 5, 2018
CompletedStudy Start
First participant enrolled
January 8, 2018
CompletedFirst Posted
Study publicly available on registry
January 18, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 20, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
March 25, 2018
CompletedFebruary 25, 2020
February 1, 2020
2 months
January 5, 2018
February 24, 2020
Conditions
Outcome Measures
Primary Outcomes (7)
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
Terminal elimination rate constant (kel)
Approximately 14 days
Terminal elimination half life, calculated as 0.693/kel (T-HALF)
Approximately 14 days
Apparent oral clearance (CL/F)
Approximately 14 days
Secondary Outcomes (2)
Incidence of adverse events (AEs)
Approximately 19 days
Incidence of serious adverse events (SAEs)
Approximately 19 days
Study Arms (1)
BMS-986165+Methotrexate+Leucovorin
EXPERIMENTALThree treatments administered
Interventions
Specified dose on specified days
Eligibility Criteria
You may qualify if:
- Body Mass Index (BMI): 18.0 - 32.0 kg/m2
- Normal renal function at screening
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
PRA Health Sciences
Groningen, 9728 NZ, Netherlands
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 5, 2018
First Posted
January 18, 2018
Study Start
January 8, 2018
Primary Completion
March 20, 2018
Study Completion
March 25, 2018
Last Updated
February 25, 2020
Record last verified: 2020-02