Clinical trial NCT05615012: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Participants
Keywords: BMS-986322
Rosuvastatin
Metformin
Methotrexate
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2022-11-14
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Maximum observed plasma concentration (Cmax)
timeFrame: Up to 21 days
measure: Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC[INF])
timeFrame: Up to 21 days
measure: Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC [0-T])
timeFrame: Up to 21 days
Secondary outcomes:
measure: Time of maximum observed plasma concentration (Tmax)
timeFrame: Up to 21 days
measure: Apparent terminal phase half-life (T-HALF)
timeFrame: Up to 21 days
measure: Apparent total body clearance (CLT/F)
timeFrame: Up to 21 days
measure: Number of participants with adverse events (AEs)
timeFrame: Up to 51 days
measure: Number of participants with vital sign abnormalities
timeFrame: Up to 51 days
measure: Number of participants with electrocardiogram (ECG) abnormalities
timeFrame: Up to 51 days
measure: Number of participants with physical examination abnormalities
timeFrame: Up to 51 days
measure: Number of participants with clinical laboratory abnormalities
timeFrame: Up to 51 days
Other outcomes:
Locations:
city: Miami
country: United States
facility: Local Institution - 0001
state: Florida
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: