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

Completed · Phase 1

Conditions studied: Healthy Volunteers

In brief

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.

Key facts

Study ID

NCT05932277

Run by

Bristol-Myers Squibb

People needed

22

Starts

2023-06-29

Expected to finish

2023-09-13

Last updated by the study team

2023-10-30

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• ICON Lenexa — Lenexa, Kansas, United States

Full record on ClinicalTrials.gov

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