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

Phase 1

Completed

• Conditions: Lupus; Psoriatic Arthritis
• Interventions: Drug: Methotrexate; Drug: Leucovorin; Drug: BMS-986165

• Registration Number: NCT03402087
• Lead Sponsor: Bristol-Myers Squibb

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-01-05
• Study Start: 2018-01-08
• Study First Submitted QC: 2018-01-16
• Study First Posted: 2018-01-18
• Primary Completion: 2018-03-20
• Study Completion: 2018-03-25
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-24
• Last Update Posted: 2020-02-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 30

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
BMS-986165+Methotrexate+Leucovorin	BMS-986165	Three treatments administered
BMS-986165+Methotrexate+Leucovorin	Leucovorin	Three treatments administered
BMS-986165+Methotrexate+Leucovorin	Methotrexate	Three treatments administered

Primary Outcome Measures

Name	Time	Method
Maximum observed plasma concentration (Cmax)	Approximately 14 days
Time to attain maximum observed plasma concentration (Tmax)	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)]	Approximately 14 days
Area under the plasma concentration-time curve from time 0 to infinity [AUC(INF)]	Approximately 14 days
Terminal elimination rate constant (kel)	Approximately 14 days
Terminal elimination half life, calculated as 0.693/kel (T-HALF)	Approximately 14 days
Apparent oral clearance (CL/F)	Approximately 14 days

Secondary Outcome Measures

Name	Time	Method
Incidence of serious adverse events (SAEs)	Approximately 19 days
Incidence of adverse events (AEs)	Approximately 19 days

Trial Locations

Locations (1)

PRA Health Sciences; 🇳🇱 Groningen, Netherlands