A Study Investigating Interactions Between BMS-986322 and Rosuvastatin, Metformin and Methotrexate in Healthy Participants
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
1 other identifier
interventional
76
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Nov 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 7, 2022
CompletedStudy Start
First participant enrolled
November 11, 2022
CompletedFirst Posted
Study publicly available on registry
November 14, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 13, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 13, 2023
CompletedMarch 27, 2024
March 1, 2024
1.1 years
November 7, 2022
March 26, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Maximum observed plasma concentration (Cmax)
Up to 21 days
Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC[INF])
Up to 21 days
Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC [0-T])
Up to 21 days
Secondary Outcomes (8)
Time of maximum observed plasma concentration (Tmax)
Up to 21 days
Apparent terminal phase half-life (T-HALF)
Up to 21 days
Apparent total body clearance (CLT/F)
Up to 21 days
Number of participants with adverse events (AEs)
Up to 51 days
Number of participants with vital sign abnormalities
Up to 51 days
- +3 more secondary outcomes
Study Arms (3)
Part 1: Rosuvastatin + BMS-986322
EXPERIMENTALPart 2: Metformin + BMS-986322 + Glucose
EXPERIMENTALPart 3: Methotrexate + BMS-986322 + Leucovorin
EXPERIMENTALInterventions
Specified dose on specified days
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Local Institution - 0001
Miami, Florida, 33136, United States
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 7, 2022
First Posted
November 14, 2022
Study Start
November 11, 2022
Primary Completion
December 13, 2023
Study Completion
December 13, 2023
Last Updated
March 27, 2024
Record last verified: 2024-03
Data Sharing
- IPD Sharing
- Will not share
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