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

Sponsor

Bristol-Myers Squibb (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05932277

Collaborator

(none)

22

Enrollment

1

Location

1

Arm

3.1

Anticipated Duration (Months)

7.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy Volunteers	Drug: BMS-986419 Drug: Caffeine Drug: Bupropion Drug: Flurbiprofen Drug: Omeprazole Drug: Midazolam Drug: Fexofenadine	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

22 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Anticipated Study Start Date :

Jun 28, 2023

Anticipated Primary Completion Date :

Sep 25, 2023

Anticipated Study Completion Date :

Sep 30, 2023

Arms and Interventions

Arm

Intervention/Treatment

Experimental: Cocktail Probe Substrates + BMS-986419

Drug: BMS-986419

Specified dose on specified days

Drug: Caffeine

Specified dose on specified days

Drug: Bupropion

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: Fexofenadine

Specified dose on specified days

Outcome Measures

Primary Outcome Measures

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Local Institution - 0001	Lenexa	Kansas	United States	66219

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators

Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.

Responsible Party:

Bristol-Myers Squibb

ClinicalTrials.gov Identifier:

NCT05932277

Other Study ID Numbers:

CN007-1000

First Posted:

Jul 6, 2023

Last Update Posted:

Jul 6, 2023

Last Verified:

Jun 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

No

Keywords provided by Bristol-Myers Squibb

pharmacokinetics

Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 6, 2023