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Completed

NCT Number: NCT05852769

A Study to Evaluate the Drug-drug Interaction Potential of BMS-986196 in Healthy Participants

This study is designed to assess the effect of BMS-986196 on the drug levels of caffeine, montelukast, flurbiprofen, omeprazole, midazolam, digoxin, and pravastatin in healthy participants.

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Key information

Conditions

Healthy Volunteers

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

ICON plc

Millcreek, Utah, 84124, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy male and female participants as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations.
  • Body mass index of 18.0 to 33.0 kilogram per meter squared (kg/m^2), inclusive, and body weight ≥50.0 kg.

Exclusion criteria

  • History of rhabdomyolysis.
  • History of peptic ulcer disease or significant GI bleeding.
  • History of malignancy in the 5 years prior to screening (except fully excised basal cell carcinoma).

Treatment and study plan

BMS-986196

Drug

Specified dose on specified days

Caffeine

Drug

Specified dose on specified days

Montelukast

Drug

Specified dose on specified days

Flurbiprofen

Drug

Specified dose on specified days

Omeprazole

Drug

Specified dose on specified days

midazolam

Drug

Specified dose on specified days

Digoxin

Drug

Specified dose on specified days

Pravastatin

Drug

Specified dose on specified days

Primary outcomes

  1. Maximum observed plasma concentration (Cmax)

    Time frame: Up to 26 days

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

    Time frame: Up to 26 days

  3. Area under the plasma concentration-time curve from time zero to time of the last quantifiable concentration (AUC[0-T])

    Time frame: Up to 26 days

Secondary outcomes

  1. Time of maximum observed serum concentration (Tmax)

    Time frame: Up to 26 days

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

    Time frame: Up to 26 days

  3. Apparent total body clearance (CLT/F)

    Time frame: Up to 26 days

  4. Number of participants with adverse events (AEs)

    Time frame: Up to 52 days

  5. Number of participants with vital sign abnormalities

    Time frame: Up to 28 days

  6. Number of participants with electrocardiogram (ECG) abnormalities

    Time frame: Up to 21 days

  7. Number of participants with physical examination abnormalities

    Time frame: Up to 28 days

  8. Number of participants with clinical laboratory abnormalities

    Time frame: Up to 28 days

  9. Intensity of Suicidal Ideation as assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS) Score

    Time frame: Up to 28 days

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

A Phase 1, Single-center, Open-label, Sequential Study to Evaluate the Drug-drug Interaction Potential of BMS-986196 in Healthy Participants

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
May 10, 2023
Registry last updated
Sep 26, 2023

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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