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

Healthy Participants Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05615012
• Other study ID #: IM032-039
• Status: Completed
• Phase: Phase 1
• Start date: November 11, 2022
• Est. completion date: December 13, 2023

Study information

• Verified date: March 2024
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: December 13, 2023
• Est. primary completion date: December 13, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Participants

Intervention

Drug:
• BMS-986322
Specified dose on specified days
• Rosuvastatin
Specified dose on specified days
• Metformin
Specified dose on specified days

Dietary Supplement:
• Glucose
Specified dose on specified days

Drug:
• Methotrexate
Specified dose on specified days
• Leucovorin
Specified dose on specified days

Locations

Country	Name	City	State
United States	Local Institution - 0001	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum observed plasma concentration (Cmax)		Up to 21 days
Primary	Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC[INF])		Up to 21 days
Primary	Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC [0-T])		Up to 21 days
Secondary	Time of maximum observed plasma concentration (Tmax)		Up to 21 days
Secondary	Apparent terminal phase half-life (T-HALF)		Up to 21 days
Secondary	Apparent total body clearance (CLT/F)		Up to 21 days
Secondary	Number of participants with adverse events (AEs)		Up to 51 days
Secondary	Number of participants with vital sign abnormalities		Up to 51 days
Secondary	Number of participants with electrocardiogram (ECG) abnormalities		Up to 51 days
Secondary	Number of participants with physical examination abnormalities		Up to 51 days
Secondary	Number of participants with clinical laboratory abnormalities		Up to 51 days

External Links

•   BMS Clinical Trial Information