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

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: Caffeine; Drug: Flurbiprofen; Drug: Omeprazole; Drug: Midazolam; Drug: BMS-986419; Drug: Bupropion; Drug: Fexofenadine

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Kansas
    • Lenexa, Kansas, United States, 66219
      • ICON Lenexa

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cocktail Probe Substrates + BMS-986419	Drug: Caffeine; Specified dose on specified days; Drug: Flurbiprofen; Specified dose on specified days; Drug: Omeprazole; Specified dose on specified days; Drug: Midazolam; Specified dose on specified days; Drug: BMS-986419; Specified dose on specified days; Drug: Bupropion; Specified dose on specified days; Drug: Fexofenadine; Specified dose on specified days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Maximum observed plasma concentration (Cmax)	Up to Day 25
Area under the plasma concentration-time curve from time zero to time of the last quantifiable concentration (AUC(0-T))	Up to Day 25
Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC(INF))	Up to Day 25

Secondary Outcome Measures

Outcome Measure	Time Frame
Maximum observed plasma concentration (Cmax)	Up to Day 25
Area under the plasma concentration-time curve from time zero to time of the last quantifiable concentration (AUC(0-T))	Up to Day 25
Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC(INF))	Up to Day 25
Number of participants with Adverse Events (AEs)	Up to 28 days after last dose
Number of participants with Serious Adverse Events (SAEs)	Up to 28 days after last dose
Number of participants with AEs leading to discontinuation	Up to 28 days after last dose
Number of participants with vital sign abnormalities	Up to Day 25
Number of participants with 12-lead ECG assessment abnormalities	Up to Day 25
Number of participants with physical examination abnormalities	Up to Day 25
Columbia-Suicide Severity Rating Scale (C-SSRS)	Up to Day 25
Number of participants with clinical laboratory abnormalities	Up to Day 25

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb
• Investigators: Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

Helpful Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

Study record dates

Study Major Dates

• Study Start (Actual): June 29, 2023
• Primary Completion (Actual): September 13, 2023
• Study Completion (Actual): September 13, 2023

Study Registration Dates

• First Submitted: June 27, 2023
• First Submitted That Met QC Criteria: June 27, 2023
• First Posted (Actual): July 6, 2023

Study Record Updates

• Last Update Posted (Actual): October 30, 2023
• Last Update Submitted That Met QC Criteria: October 27, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: pharmacokinetics; healthy; BMS-986419
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Purinergic Antagonists; Purinergic Agents; Gastrointestinal Agents; Tranquilizing Agents; Psychotropic Drugs; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Antidepressive Agents; Dopamine Agents; Hypnotics and Sedatives; Adjuvants, Anesthesia; Anti-Anxiety Agents; GABA Modulators; GABA Agents; Cytochrome P-450 Enzyme Inhibitors; Antidepressive Agents, Second-Generation; Cytochrome P-450 CYP2D6 Inhibitors; Anti-Ulcer Agents; Proton Pump Inhibitors; Dopamine Uptake Inhibitors; Anti-Allergic Agents; Phosphodiesterase Inhibitors; Purinergic P1 Receptor Antagonists; Histamine H1 Antagonists; Histamine Antagonists; Histamine Agents; Central Nervous System Stimulants; Histamine H1 Antagonists, Non-Sedating; Midazolam; Bupropion; Caffeine; Omeprazole; Flurbiprofen; Fexofenadine
• Other Study ID Numbers: CN007-1000

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No