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OpenTrials
Completed

NCT Number: NCT05615012

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

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Local Institution - 0001

Miami, Florida, 33136, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

BMS-986322

Drug

Specified dose on specified days

Rosuvastatin

Drug

Specified dose on specified days

metformin

Drug

Specified dose on specified days

Glucose

Dietary Supplement

Specified dose on specified days

methotrexate

Drug

Specified dose on specified days

Leucovorin

Drug

Specified dose on specified days

Primary outcomes

  1. Maximum observed plasma concentration (Cmax)

    Time frame: Up to 21 days

  2. Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC[INF])

    Time frame: Up to 21 days

  3. 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 outcomes

  1. Time of maximum observed plasma concentration (Tmax)

    Time frame: Up to 21 days

  2. Apparent terminal phase half-life (T-HALF)

    Time frame: Up to 21 days

  3. Apparent total body clearance (CLT/F)

    Time frame: Up to 21 days

  4. Number of participants with adverse events (AEs)

    Time frame: Up to 51 days

  5. Number of participants with vital sign abnormalities

    Time frame: Up to 51 days

  6. Number of participants with electrocardiogram (ECG) abnormalities

    Time frame: Up to 51 days

  7. Number of participants with physical examination abnormalities

    Time frame: Up to 51 days

  8. Number of participants with clinical laboratory abnormalities

    Time frame: Up to 51 days

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Nov 14, 2022
Registry last updated
Mar 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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