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

Psoriatic Arthritis Clinical Trial

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

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
• 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
• 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

Related Conditions & MeSH terms

• Arthritis, Psoriatic
• Lupus
• Psoriatic Arthritis

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

External Links

•   BMS Clinical Trial Patient Recruiting
•   Investigator Inquiry Form