Back to resultsA Study to Investigate BMS-986165 and Methotrexate in Healthy Male Patients
Primary Purpose
Lupus, Psoriatic Arthritis
Status
Completed
Phase
Phase 1
Locations
Netherlands
Study Type
Interventional
Intervention
Methotrexate
Leucovorin
BMS-986165
Sponsored by
About this trial
This is an interventional treatment trial for Lupus
Eligibility 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
Sites / Locations
- PRA Health Sciences
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
BMS-986165+Methotrexate+Leucovorin
Arm Description
Three treatments administered
Outcomes
Primary Outcome Measures
Maximum observed plasma concentration (Cmax)
Time to attain maximum observed plasma concentration (Tmax)
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)]
Area under the plasma concentration-time curve from time 0 to infinity [AUC(INF)]
Terminal elimination rate constant (kel)
Terminal elimination half life, calculated as 0.693/kel (T-HALF)
Apparent oral clearance (CL/F)
Secondary Outcome Measures
Incidence of adverse events (AEs)
Incidence of serious adverse events (SAEs)
Full Information
NCT ID
NCT03402087
First Posted
January 5, 2018
Last Updated
February 24, 2020
Sponsor
Bristol-Myers Squibb
1. Study Identification
Unique Protocol Identification Number
NCT03402087
Brief Title
A Study to Investigate BMS-986165 and Methotrexate in Healthy Male Patients
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
January 8, 2018 (Actual)
Primary Completion Date
March 20, 2018 (Actual)
Study Completion Date
March 25, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bristol-Myers Squibb
4. Oversight
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
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lupus, Psoriatic Arthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
BMS-986165+Methotrexate+Leucovorin
Arm Type
Experimental
Arm Description
Three treatments administered
Intervention Type
Drug
Intervention Name(s)
Methotrexate
Other Intervention Name(s)
MTX
Intervention Description
Specified dose on specified days
Intervention Type
Drug
Intervention Name(s)
Leucovorin
Other Intervention Name(s)
LEU
Intervention Description
Specified dose on specified days
Intervention Type
Drug
Intervention Name(s)
BMS-986165
Intervention Description
Specified dose on specified days
Primary Outcome Measure Information:
Title
Maximum observed plasma concentration (Cmax)
Time Frame
Approximately 14 days
Title
Time to attain maximum observed plasma concentration (Tmax)
Time Frame
Approximately 14 days
Title
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
Title
Area under the plasma concentration-time curve from time 0 to infinity [AUC(INF)]
Time Frame
Approximately 14 days
Title
Terminal elimination rate constant (kel)
Time Frame
Approximately 14 days
Title
Terminal elimination half life, calculated as 0.693/kel (T-HALF)
Time Frame
Approximately 14 days
Title
Apparent oral clearance (CL/F)
Time Frame
Approximately 14 days
Secondary Outcome Measure Information:
Title
Incidence of adverse events (AEs)
Time Frame
Approximately 19 days
Title
Incidence of serious adverse events (SAEs)
Time Frame
Approximately 19 days
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
PRA Health Sciences
City
Groningen
ZIP/Postal Code
9728 NZ
Country
Netherlands
12. IPD Sharing Statement
Links:
URL
http://bms.com/studyconnect/Pages/home.aspx
Description
BMS Clinical Trial Patient Recruiting
Learn more about this trial
A Study to Investigate BMS-986165 and Methotrexate in Healthy Male Patients
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