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A Study to Assess the Levels in Blood Plasma of BMS-986278 in Healthy Participants Following Administration of Tablets, With or Without Food, and in the Presence of an Antacid (Esomeprazole)

An Open-Label Study to Assess Relative Bioavailability, Food Effect, and Esomeprazole Drug-Drug Interaction of BMS-986278 Tablets Following a Single Dose Administration in Healthy Participants

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04468815
Enrollment
24
Registered
2020-07-13
Start date
2020-07-10
Completion date
2020-10-07
Last updated
2022-05-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Participants

Brief summary

The purpose of this study is to assess levels in blood plasma of BMS-986278 and the food effect in healthy participants.

Interventions

DRUGBMS-986278 Tablet

Specified dose on specified days

DRUGEsomeprazole

Specified dose on specified days

DRUGBMS-986278 suspension

Specified dose on specified days

Sponsors

Bristol-Myers Squibb
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
21 Years to 65 Years
Healthy volunteers
Yes

Inclusion criteria

* Healthy participants, as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations in the opinion of the investigator * Women and men must agree to follow specific methods of contraception

Exclusion criteria

* Women of childbearing potential (WOCBP) and Women who are pregnant or breastfeeding * Any significant acute or chronic medical condition that presents a potential risk to the participant and/or that may compromise the objectives of the study * Exposure to any investigational drug or placebo within 4 weeks of first study treatment administration. * History of any significant drug and/or food allergies (such as anaphylaxis or hepatotoxicity) Other protocol-defined inclusion/

Design outcomes

Primary

MeasureTime frame
Maximum plasma concentration (Cmax) of BMS-986278Up to 5 days
Area under the concentration-time curve from time 0 (dosing) to the time of the last quantifiable concentration observed (AUC(0-T) of BMS-986278Up to 5 days
Area under the concentration-time curve from time 0 (dosing) extrapolated to infinity AUC (INF) of BMS-986278 from the respective test treatmentsUp to 5 days

Secondary

MeasureTime frame
Incidence of clinically significant changes in vital signs: Blood pressureUp to 48 days
Incidence of clinically significant changes in vital signs: Heart rateUp to 48 days
Incidence of clinically significant changes in vital signs: Respiratory rateUp to 48 days
Incidence of clinically significant changes in vital signs: Body temperatureUp to 48 days
Incidence of Adverse Events (AEs)Up to 29 days
Incidence of clinically significant changes in physical examination findingsUp to 48 days
Incidence of clinically significant changes in clinical laboratory results: Clinical chemistry testsUp to 48 days
Incidence of clinically significant changes in clinical laboratory results: Urinalysis testsUp to 48 days
Incidence of clinically significant changes in clinical laboratory results: Hematology testsUp to 48 days
Incidence of clinically significant changes in electrocardiogram (ECG) parametersUp to 48 days
Incidence of Serious Adverse (SAE's)Up to 57 days
Incidence of AEs leading to discontinuationUp to 29 days

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026