CompletedNCT03402087Updated Feb 25, 2020

A Study to Investigate BMS-986165 and Methotrexate in Healthy Male Patients

A Phase 1 interventional study of Methotrexate and Leucovorin in Lupus and Psoriatic Arthritis, sponsored by Bristol-Myers Squibb. Completed at 1 site in Netherlands. Open to male participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-02-25.

Sponsored by Bristol-Myers Squibb · Phase 1, Interventional, and Treatment

Phase: Phase 1
Study type: Interventional
Enrollment: 30
Allocation: Not applicable
Ages: 18 Years to 50 Years
Sex: Male

Study 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.

Conditions studied

Lupus
Psoriatic Arthritis

Browse trials for

Arthritis, Psoriatic 577

Who can participate

Ages eligible: 18 Years to 50 Years
Sexes eligible: Male
Accepts healthy volunteers: Yes

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion criteria

Inclusion Criteria:

Body Mass Index (BMI): 18.0 - 32.0 kg/m2
Normal renal function at screening

Exclusion criteria

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

Phase: Phase 1
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 30 participants (actual)

Study arms

Experimental
BMS-986165+Methotrexate+Leucovorin
Three treatments administered
Drug: Methotrexate · Drug: Leucovorin · Drug: BMS-986165

Interventions

DrugMethotrexate
Specified dose on specified days
Also known as: MTX
DrugLeucovorin
Specified dose on specified days
Also known as: LEU
DrugBMS-986165
Specified dose on specified days

What researchers measure

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 adverse events (AEs)
Time frame: Approximately 19 days
Incidence of serious adverse events (SAEs)
Time frame: Approximately 19 days

Study locations

1 site

PRA Health Sciences
Groningen, 9728 NZ, Netherlands

References and documents

Registry details

Key details

Study ID: NCT03402087
Lead sponsor: Bristol-Myers Squibb
Responsible party: Sponsor
First posted: Jan 18, 2018
Start date: Jan 8, 2018
Primary completion: Mar 20, 2018
Completion: Mar 25, 2018
Last update: Feb 25, 2020

Study contacts

Bristol-Myers Squibb

study director · Bristol-Myers Squibb

Oversight

FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.

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