Status:
COMPLETED
A Study to Investigate BMS-986165 and Methotrexate in Healthy Male Patients
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Lupus
Psoriatic Arthritis
Eligibility:
MALE
18-50 years
Phase:
PHASE1
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.
Eligibility Criteria
Inclusion
- For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com
- Body Mass Index (BMI): 18.0 - 32.0 kg/m2
- Normal renal function at screening
Exclusion
- 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
Key Trial Info
Start Date :
January 8 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 25 2018
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT03402087
Start Date
January 8 2018
End Date
March 25 2018
Last Update
February 25 2020
Active Locations (1)
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1
PRA Health Sciences
Groningen, Netherlands, 9728 NZ