A Study to Evaluate the Drug Exposure of Single Ascending Doses of BMS-986369 and the Effect of Food on the BMS-986369 in Healthy Participants

Healthy Volunteer Clinical Trial

Official title:

A Phase 1, Two-part Study to Evaluate the Pharmacokinetics, and Pharmacodynamics of Single Ascending Doses of BMS-986369 and to Explore the Effect of Food the Bioavailability of BMS-986369 in Healthy Participants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05350800
• Other study ID #: CA073-001
• Status: Completed
• Phase: Phase 1
• Start date: September 12, 2022
• Est. completion date: May 4, 2023

Study information

• Verified date: May 2023
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the safety, tolerability, drug levels of BMS-986369 following administration of single ascending oral doses (SAD) in healthy adult participants. The study will also explore the effect of high-fat meal on the single-dose drug level of BMS-986369 in healthy adult participants.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: May 4, 2023
• Est. primary completion date: May 4, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Body mass index (BMI) 18.0 to 33.0 kg/m2, inclusive. BMI = weight (kg)/(height [m])2 for participants

• Must have a normal or clinically-acceptable 12-lead ECG at screening

• Absolute neutrophil counts must be greater than 2,500/µL at screening and Day -1

Exclusion Criteria:

• Any significant acute or chronic medical illness that presents a potential risk to the participant in the opinion of the investigator and/or may compromise the objectives of the study

• History of clinically significant endocrine, gastrointestinal (GI), cardiovascular (CV), peripheral vascular, hematological, hepatic, immunological, renal, respiratory, or genitourinary (GU) abnormalities/diseases

• History of major surgery within 8 weeks before the first dose administration

Other protocol-defined inclusion/exclusion criteria apply

Related Conditions & MeSH terms

• Healthy Volunteer

Intervention

Drug:
• BMS-986369
Specified dose on specified days

Locations

Country	Name	City	State
United States	Local Institution - 0001	Miami	Florida

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 observed plasma concentration (Cmax)		Day 1
Primary	Time of maximum observed plasma concentration (Tmax)		Day 1
Primary	Area under the plasma concentration-time curve, from time zero extrapolated to infinite time (AUC(INF))		Up to 336 hours after dose administration
Secondary	Number of participants with Adverse Events (AEs)		From the date of having consented until 30 days after completion of study treatment
Secondary	Number of participants with vital sign abnormalities		Up to Day 15
Secondary	Number of participants with clinical laboratory abnormalities		Up to Day 15
Secondary	Number of participants with electrocardiogram (ECG) abnormalities		Up to Day 15
Secondary	Effect of BMS-986369 on ECG parameters - Part 1		Up to 72 hours

External Links

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