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)

Healthy Participants Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04468815
• Other study ID #: IM027-054
• Status: Completed
• Phase: Phase 1
• Start date: July 10, 2020
• Est. completion date: October 7, 2020

Study information

• Verified date: May 2022
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: October 7, 2020
• Est. primary completion date: October 7, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Participants

Intervention

Drug:
• BMS-986278 Tablet
Specified dose on specified days
• Esomeprazole
Specified dose on specified days
• BMS-986278 suspension
Specified dose on specified days

Locations

Country	Name	City	State
United States	ICON (LPRA) - Salt Lake	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum plasma concentration (Cmax) of BMS-986278		Up to 5 days
Primary	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		Up to 5 days
Primary	Area under the concentration-time curve from time 0 (dosing) extrapolated to infinity AUC (INF) of BMS-986278 from the respective test treatments		Up to 5 days
Secondary	Incidence of Adverse Events (AEs)		Up to 29 days
Secondary	Incidence of Serious Adverse (SAE's)		Up to 57 days
Secondary	Incidence of AEs leading to discontinuation		Up to 29 days
Secondary	Incidence of clinically significant changes in vital signs: Blood pressure		Up to 48 days
Secondary	Incidence of clinically significant changes in vital signs: Heart rate		Up to 48 days
Secondary	Incidence of clinically significant changes in vital signs: Respiratory rate		Up to 48 days
Secondary	Incidence of clinically significant changes in vital signs: Body temperature		Up to 48 days
Secondary	Incidence of clinically significant changes in electrocardiogram (ECG) parameters		Up to 48 days
Secondary	Incidence of clinically significant changes in physical examination findings		Up to 48 days
Secondary	Incidence of clinically significant changes in clinical laboratory results: Clinical chemistry tests		Up to 48 days
Secondary	Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests		Up to 48 days
Secondary	Incidence of clinically significant changes in clinical laboratory results: Hematology tests		Up to 48 days

External Links

•   BMS Clinical Trial Information
•   BMS Clinical Trial Patient Recruiting
•   FDA Safety Alerts and Recalls
•   Investigator Inquiry Form