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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03402087
Other study ID # IM011-025
Secondary ID 2017-004177-13
Status Completed
Phase Phase 1
First received
Last updated
Start date January 8, 2018
Est. completion date March 25, 2018

Study information

Verified date February 2020
Source Bristol-Myers Squibb
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date March 25, 2018
Est. primary completion date March 20, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 50 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Methotrexate
Specified dose on specified days
Leucovorin
Specified dose on specified days
BMS-986165
Specified dose on specified days

Locations

Country Name City State
Netherlands PRA Health Sciences Groningen

Sponsors (1)

Lead Sponsor Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Primary Maximum observed plasma concentration (Cmax) Approximately 14 days
Primary Time to attain maximum observed plasma concentration (Tmax) Approximately 14 days
Primary 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
Primary Area under the plasma concentration-time curve from time 0 to infinity [AUC(INF)] Approximately 14 days
Primary Terminal elimination rate constant (kel) Approximately 14 days
Primary Terminal elimination half life, calculated as 0.693/kel (T-HALF) Approximately 14 days
Primary Apparent oral clearance (CL/F) Approximately 14 days
Secondary Incidence of adverse events (AEs) Approximately 19 days
Secondary Incidence of serious adverse events (SAEs) Approximately 19 days
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