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OpenTrials
Completed

NCT Number: NCT05932277

A Study to Assess the Effect of BMS-986419 on the Single Dose Drug Levels of Probe Substrates in Healthy Participants

The purpose of this study is to assess the effect of BMS-986419 on the pharmacokinetics (PK) of single doses of caffeine (CYP1A2 substrate), bupropion (CYP2B6 substrate), midazolam (CYP3A4 substrate), flurbiprofen (CYP2C9 substrate), omeprazole (CYP2C19 substrate), and fexofenadine (P-gp substrate), 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 Lenexa

Lenexa, Kansas, 66219, 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 without clinically significant deviation from normal in medical history, physical examination (PE), electrocardiogram (ECG), and clinical laboratory determinations (congenital nonhemolytic hyperbilirubinemia [eg, suspicion of Gilbert's syndrome based on total and direct bilirubin] is not acceptable) at screening and check-in (Day -1).
  • Body Mass Index (BMI) of 18 to 32 kg/m2, inclusive, and total body weight ≥ 50 kg. BMI may be rounded.

Exclusion criteria

  • Any significant acute or chronic medical conditions or any significant acute or chronic medical illness as determined by the investigator
  • Any major surgery within 30 days of study intervention administration, such as gastrointestinal surgery that could impact the absorption of study intervention

Other protocol-defined inclusion/exclusion criteria apply.

Treatment and study plan

BMS-986419

Drug

Specified dose on specified days

Caffeine

Drug

Specified dose on specified days

bupropion

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

fexofenadine

Drug

Specified dose on specified days

Primary outcomes

  1. Maximum observed plasma concentration (Cmax)

    Time frame: Up to Day 25

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

    Time frame: Up to Day 25

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

    Time frame: Up to Day 25

Secondary outcomes

  1. Maximum observed plasma concentration (Cmax)

    Time frame: Up to Day 25

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

    Time frame: Up to Day 25

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

    Time frame: Up to Day 25

  4. Number of participants with Adverse Events (AEs)

    Time frame: Up to 28 days after last dose

  5. Number of participants with Serious Adverse Events (SAEs)

    Time frame: Up to 28 days after last dose

  6. Number of participants with AEs leading to discontinuation

    Time frame: Up to 28 days after last dose

  7. Number of participants with vital sign abnormalities

    Time frame: Up to Day 25

  8. Number of participants with 12-lead ECG assessment abnormalities

    Time frame: Up to Day 25

  9. Number of participants with physical examination abnormalities

    Time frame: Up to Day 25

  10. Columbia-Suicide Severity Rating Scale (C-SSRS)

    Time frame: Up to Day 25

  11. Number of participants with clinical laboratory abnormalities

    Time frame: Up to Day 25

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

A Phase 1 Open-label Study to Assess the Effect of BMS-986419 on the Single Dose Pharmacokinetics of Probe Substrates (Caffeine, Bupropion, Flurbiprofen, Omeprazole, Midazolam, and Fexofenadine) in Healthy Participants

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jul 6, 2023
Registry last updated
Oct 30, 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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