Clinical trial NCT04468815: 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)
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Participants
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2020-07-13
Enrollment: 24
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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


Eligibility criteria: 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/exclusion criteria apply

Primary outcomes:
measure: Maximum plasma concentration (Cmax) of BMS-986278
timeFrame: Up to 5 days
measure: Area under the concentration-time curve from time 0 (dosing) to the time of the last quantifiable concentration observed (AUC(0-T) of BMS-986278
timeFrame: Up to 5 days
measure: Area under the concentration-time curve from time 0 (dosing) extrapolated to infinity AUC (INF) of BMS-986278 from the respective test treatments
timeFrame: Up to 5 days
Secondary outcomes:
measure: Incidence of Adverse Events (AEs)
timeFrame: Up to 29 days
measure: Incidence of Serious Adverse (SAE's)
timeFrame: Up to 57 days
measure: Incidence of AEs leading to discontinuation
timeFrame: Up to 29 days
measure: Incidence of clinically significant changes in vital signs: Blood pressure
timeFrame: Up to 48 days
measure: Incidence of clinically significant changes in vital signs: Heart rate
timeFrame: Up to 48 days
measure: Incidence of clinically significant changes in vital signs: Respiratory rate
timeFrame: Up to 48 days
measure: Incidence of clinically significant changes in vital signs: Body temperature
timeFrame: Up to 48 days
measure: Incidence of clinically significant changes in electrocardiogram (ECG) parameters
timeFrame: Up to 48 days
measure: Incidence of clinically significant changes in physical examination findings
timeFrame: Up to 48 days
measure: Incidence of clinically significant changes in clinical laboratory results: Clinical chemistry tests
timeFrame: Up to 48 days
measure: Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests
timeFrame: Up to 48 days
measure: Incidence of clinically significant changes in clinical laboratory results: Hematology tests
timeFrame: Up to 48 days
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: ICON (LPRA) - Salt Lake
state: Utah
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: