A Study to Assess the Effects of BMS-986371 on the Drug Levels of Methotrexate in the Presence and Absence of Sulfasalazine

NCT05445440 — Phase 1, Completed, 30 participants, Bristol-Myers Squibb

ClinicalTrials Daily · Areas · Conditions · Drugs · Sponsors ·

A Phase 1, Two-part, Open-label, Drug-drug Interaction Study in Healthy Male Adult Participants to Evaluate the Effects of BMS-986371 on the Pharmacokinetics of Methotrexate in the Presence and Absence of Sulfasalazine

Registry	NCT05445440
Status	Completed
Phase	Phase 1
Study type	Interventional; non randomized, sequential, masking: none, treatment
Enrollment	30 (Actual)
Sponsor	Bristol-Myers Squibb (Industry)
Conditions	Healthy Participants
Interventions	Methotrexate, Leucovorin, BMS-986371, Sulfasalazine (Drug)
Dates	start 2022-09-06, primary completion 2022-11-17, completion 2022-11-23, first posted 2022-07-06, last updated 2023-02-08
Locations	1 site in United States

-Summary

The purpose of this study is to evaluate the effects of BMS-986371 on the drug levels of methotrexate, sulfasalazine and their main metabolites in healthy male adult participants.

Expand all sections · Collapse all

+Detailed description

This study will allow investigation of potential drug-drug interaction mediated through drug transporter proteins. During each part, blood samples will be collected at prespecified times for pharmacokinetic assessments. Subject safety will be monitored throughout the study. There will be approximately 16 subjects enrolled into each part.

+Arms and interventions

Arm	Type	Interventions	Description
Part 1	Experimental	Drug: Methotrexate; Drug: Leucovorin; Drug: BMS-986371
Part 2	Experimental	Drug: Methotrexate; Drug: Leucovorin; Drug: BMS-986371; Drug: Sulfasalazine

Methotrexate (Drug): Specified dose on specified days
Leucovorin (Drug): Specified dose on specified days
BMS-986371 (Drug), also known as CC-99677: Specified dose on specified days
Sulfasalazine (Drug): Specified dose on specified days

+Outcome measures

Primary outcomes

Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration (AUC[0-T]) [Up to 22 days]: Part 1
Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC[INF]) [Up to 22 days]: Part 1
Maximum observed plasma concentration (Cmax) [Up to 22 days]: Part 1

Secondary outcomes

AUC(0-T) [Up to 22 days]: Part 2
AUC(INF) [Up to 22 days]: Part 2
Cmax [Up to 22 days]: Part 2
Number of participants with adverse events (AEs) [Up to 30 days post participant's last study treatment]: Parts 1 and 2

+Eligibility

Sex: Male, ages: 18 Years to 50 Years, accepts healthy volunteers

Inclusion Criteria:

* Participant has physical exam, vital signs, clinical laboratory safety and other medical test results that are within normal limits, considered not clinically significant by the Investigator, or within other parameters specified in the protocol
* Body mass index of 18 to 32 kg/m\^2, inclusive

Exclusion Criteria:

* Any significant acute or chronic medical illness
* Current or recent (within 3 months of study intervention administration) gastrointestinal disease that could possibly affect the absorption, distribution, metabolism and excretion of study drug
* Any other medical, psychiatric and/or social reason as determined by the Investigator

Other protocol-defined inclusion/exclusion criteria apply

+Locations (1)

Facility	City	Country	Status
Quotient Sciences Miami	Miami, Florida	United States

+Investigators

Bristol-Myers Squibb, Study director, Bristol-Myers Squibb

My Notes

Public

To Read Reading Read