search
Back to results

A Study Investigating Interactions Between BMS-986322 and Rosuvastatin, Metformin and Methotrexate in Healthy Participants

Primary Purpose

Healthy Participants

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
BMS-986322
Rosuvastatin
Metformin
Glucose
Methotrexate
Leucovorin
Sponsored by
Bristol-Myers Squibb
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Healthy Participants focused on measuring BMS-986322, Rosuvastatin, Metformin, Methotrexate

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: In the opinion of the investigator, a healthy participant, as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations. Body mass index (BMI) of 18.0 kilogram (kg)/meter(m)^2 to 30.0 kg/m^2, inclusive, and body weight ≥ 50 kg for males and ≥ 45 kg for females, at screening. A female participant is eligible to participate if she is a woman not of childbearing potential. Female participants must refrain from donating oocytes during the intervention period and for at least 5 half-lives (5 days) after the last dose of study intervention. For Parts 1 and 2 participants must be 18 to 60 years of age. For Part 3 participants must be 18 to 50 years of age. Exclusion Criteria: Any significant acute or chronic medical illness. Any major surgery, including any gastrointestinal (GI) surgery, with the exception of appendectomy, within 90 days of study intervention administration. History of alcohol abuse within 1 year prior to screening or regular use of alcohol within 6 months prior to screening that exceeds 7 units for women or 14 units for men of alcohol per week (1 unit = 340 mililitre [mL] of beer 5%, 140 mL of wine 12%, or 45 mL of distilled alcohol 40%). Participant must not have a known or suspected immune-mediated disorder, or any history of known or suspected congenital or acquired immunodeficiency state or condition that would compromise the participant's immune status. Participant must not have any history or risk for tuberculosis (TB) in participants with current clinical, radiographic, or laboratory evidence of active TB. Other protocol-defined inclusion/exclusion criteria apply.

Sites / Locations

  • Local Institution - 0001Recruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Part 1: Rosuvastatin + BMS-986322

Part 2: Metformin + BMS-986322 + Glucose

Part 3: Methotrexate + BMS-986322 + Leucovorin

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Time of maximum observed plasma concentration (Tmax)
Apparent terminal phase half-life (T-HALF)
Apparent total body clearance (CLT/F)
Number of participants with adverse events (AEs)
Number of participants with vital sign abnormalities
Number of participants with electrocardiogram (ECG) abnormalities
Number of participants with physical examination abnormalities
Number of participants with clinical laboratory abnormalities

Full Information

First Posted
November 7, 2022
Last Updated
September 7, 2023
Sponsor
Bristol-Myers Squibb
search

1. Study Identification

Unique Protocol Identification Number
NCT05615012
Brief Title
A Study Investigating Interactions Between BMS-986322 and Rosuvastatin, Metformin and Methotrexate in Healthy Participants
Official Title
An Open-Label, Single-Sequence Crossover, Drug-Drug Interaction Study to Assess the Effect of Steady-State BMS-986322 on the Pharmacokinetics of Rosuvastatin (Part 1), the Pharmacokinetics and Pharmacodynamics of Metformin (Part 2) and the Pharmacokinetics of Methotrexate (Part 3) in Healthy Participants
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 11, 2022 (Actual)
Primary Completion Date
November 24, 2023 (Anticipated)
Study Completion Date
November 24, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bristol-Myers Squibb

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The aim of this study is to assess the effect of coadministration of multiple oral doses of BMS-986322 with rosuvastatin, metformin, and methotrexate in healthy participants.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy Participants
Keywords
BMS-986322, Rosuvastatin, Metformin, Methotrexate

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
76 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Part 1: Rosuvastatin + BMS-986322
Arm Type
Experimental
Arm Title
Part 2: Metformin + BMS-986322 + Glucose
Arm Type
Experimental
Arm Title
Part 3: Methotrexate + BMS-986322 + Leucovorin
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
BMS-986322
Intervention Description
Specified dose on specified days
Intervention Type
Drug
Intervention Name(s)
Rosuvastatin
Intervention Description
Specified dose on specified days
Intervention Type
Drug
Intervention Name(s)
Metformin
Intervention Description
Specified dose on specified days
Intervention Type
Dietary Supplement
Intervention Name(s)
Glucose
Intervention Description
Specified dose on specified days
Intervention Type
Drug
Intervention Name(s)
Methotrexate
Intervention Description
Specified dose on specified days
Intervention Type
Drug
Intervention Name(s)
Leucovorin
Intervention Description
Specified dose on specified days
Primary Outcome Measure Information:
Title
Maximum observed plasma concentration (Cmax)
Time Frame
Up to 21 days
Title
Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC[INF])
Time Frame
Up to 21 days
Title
Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC [0-T])
Time Frame
Up to 21 days
Secondary Outcome Measure Information:
Title
Time of maximum observed plasma concentration (Tmax)
Time Frame
Up to 21 days
Title
Apparent terminal phase half-life (T-HALF)
Time Frame
Up to 21 days
Title
Apparent total body clearance (CLT/F)
Time Frame
Up to 21 days
Title
Number of participants with adverse events (AEs)
Time Frame
Up to 51 days
Title
Number of participants with vital sign abnormalities
Time Frame
Up to 51 days
Title
Number of participants with electrocardiogram (ECG) abnormalities
Time Frame
Up to 51 days
Title
Number of participants with physical examination abnormalities
Time Frame
Up to 51 days
Title
Number of participants with clinical laboratory abnormalities
Time Frame
Up to 51 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: In the opinion of the investigator, a healthy participant, as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations. Body mass index (BMI) of 18.0 kilogram (kg)/meter(m)^2 to 30.0 kg/m^2, inclusive, and body weight ≥ 50 kg for males and ≥ 45 kg for females, at screening. A female participant is eligible to participate if she is a woman not of childbearing potential. Female participants must refrain from donating oocytes during the intervention period and for at least 5 half-lives (5 days) after the last dose of study intervention. For Parts 1 and 2 participants must be 18 to 60 years of age. For Part 3 participants must be 18 to 50 years of age. Exclusion Criteria: Any significant acute or chronic medical illness. Any major surgery, including any gastrointestinal (GI) surgery, with the exception of appendectomy, within 90 days of study intervention administration. History of alcohol abuse within 1 year prior to screening or regular use of alcohol within 6 months prior to screening that exceeds 7 units for women or 14 units for men of alcohol per week (1 unit = 340 mililitre [mL] of beer 5%, 140 mL of wine 12%, or 45 mL of distilled alcohol 40%). Participant must not have a known or suspected immune-mediated disorder, or any history of known or suspected congenital or acquired immunodeficiency state or condition that would compromise the participant's immune status. Participant must not have any history or risk for tuberculosis (TB) in participants with current clinical, radiographic, or laboratory evidence of active TB. Other protocol-defined inclusion/exclusion criteria apply.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
BMS Study Connect Contact Center www.BMSStudyConnect.com
Phone
855-907-3286
Email
Clinical.Trials@bms.com
First Name & Middle Initial & Last Name or Official Title & Degree
First line of the email MUST contain the NCT# and Site #.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
Local Institution - 0001
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myers Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosurecommitment.html
Links:
URL
https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Description
BMS Clinical Trial Information
URL
https://www.bmsstudyconnect.com/s/US/English/USenHome
Description
BMS Clinical Trial Patient Recruiting
URL
https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Description
Investigator Inquiry Form
URL
https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm
Description
FDA Safety Alerts and Recalls

Learn more about this trial

A Study Investigating Interactions Between BMS-986322 and Rosuvastatin, Metformin and Methotrexate in Healthy Participants

We'll reach out to this number within 24 hrs