ICON (LPRA) - Salt Lake
Salt Lake City, Utah, 84124, United States
Completed
NCT Number: 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)
The purpose of this study is to assess levels in blood plasma of BMS-986278 and the food effect in healthy participants.
Completed
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Notify MeKey information
Conditions
Age range
21 year–65 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 1
Primary location
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
BMS-986278 Tablet
DrugSpecified dose on specified days
Esomeprazole
DrugSpecified dose on specified days
Other names: NEXIUM
BMS-986278 suspension
DrugSpecified dose on specified days
Primary outcomes
-
Maximum plasma concentration (Cmax) of BMS-986278
Time frame: Up 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-986278
Time frame: Up 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 treatments
Time frame: Up to 5 days
Secondary outcomes
-
Incidence of Adverse Events (AEs)
Time frame: Up to 29 days
-
Incidence of Serious Adverse (SAE's)
Time frame: Up to 57 days
-
Incidence of AEs leading to discontinuation
Time frame: Up to 29 days
-
Incidence of clinically significant changes in vital signs: Blood pressure
Time frame: Up to 48 days
-
Incidence of clinically significant changes in vital signs: Heart rate
Time frame: Up to 48 days
-
Incidence of clinically significant changes in vital signs: Respiratory rate
Time frame: Up to 48 days
-
Incidence of clinically significant changes in vital signs: Body temperature
Time frame: Up to 48 days
-
Incidence of clinically significant changes in electrocardiogram (ECG) parameters
Time frame: Up to 48 days
-
Incidence of clinically significant changes in physical examination findings
Time frame: Up to 48 days
-
Incidence of clinically significant changes in clinical laboratory results: Clinical chemistry tests
Time frame: Up to 48 days
-
Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests
Time frame: Up to 48 days
-
Incidence of clinically significant changes in clinical laboratory results: Hematology tests
Time frame: Up to 48 days
Sponsors and collaborators
Lead sponsor
Bristol-Myers Squibb
Industry
Registry information
Official study 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
Important dates
- Study start
- 2020
- Primary completion
- 2020
- Study completion
- 2020
- First posted
- Jul 13, 2020
- Registry last updated
- May 10, 2022
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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