Clinical trial NCT05932277: A Study to Assess the Effect of BMS-986419 on the Single Dose Drug Levels of Probe Substrates in Healthy Participants
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Keywords: healthy
pharmacokinetics
BMS-986419
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2023-07-06
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Maximum observed plasma concentration (Cmax)
timeFrame: Up to Day 25
measure: Area under the plasma concentration-time curve from time zero to time of the last quantifiable concentration (AUC(0-T))
timeFrame: Up to Day 25
measure: Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC(INF))
timeFrame: Up to Day 25
Secondary outcomes:
measure: Maximum observed plasma concentration (Cmax)
timeFrame: Up to Day 25
measure: Area under the plasma concentration-time curve from time zero to time of the last quantifiable concentration (AUC(0-T))
timeFrame: Up to Day 25
measure: Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC(INF))
timeFrame: Up to Day 25
measure: Number of participants with Adverse Events (AEs)
timeFrame: Up to 28 days after last dose
measure: Number of participants with Serious Adverse Events (SAEs)
timeFrame: Up to 28 days after last dose
measure: Number of participants with AEs leading to discontinuation
timeFrame: Up to 28 days after last dose
measure: Number of participants with vital sign abnormalities
timeFrame: Up to Day 25
measure: Number of participants with 12-lead ECG assessment abnormalities
timeFrame: Up to Day 25
measure: Number of participants with physical examination abnormalities
timeFrame: Up to Day 25
measure: Columbia-Suicide Severity Rating Scale (C-SSRS)
timeFrame: Up to Day 25
measure: Number of participants with clinical laboratory abnormalities
timeFrame: Up to Day 25
Other outcomes:
Locations:
city: Lenexa
country: United States
facility: ICON Lenexa
state: Kansas
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: