NCT05760937
Completed
Phase 1
A Phase 1 Randomized, Double-blind, Placebo-controlled, First-in-human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single, Ascending Doses of BMS-986447 in Healthy Adult Participants
ConditionsHealthy Participants
Overview
- Phase
- Phase 1
- Intervention
- BMS-986447
- Conditions
- Healthy Participants
- Sponsor
- Bristol-Myers Squibb
- Enrollment
- 32
- Locations
- 1
- Primary Endpoint
- Number of Participants with Serious AEs (SAEs)
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
The purpose of the study is to evaluate the safety, tolerability and drug levels of single, oral doses of BMS-986447 in healthy participants.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Body mass index between 18 and 30 kilograms per metered square (kg/m\^2), inclusive.
- •Healthy male and female participants without clinically significant deviation from normal in medical history, physical examination, ECG, and clinical laboratory determinations.
- •A negative COVID-19 test, which will be performed in the manner mandated by the clinical side where the study is being conducted, at screening and check-in Day -2.
Exclusion Criteria
- •Participant has any condition that confounds the ability to interpret data from the study.
- •Participant has any condition including the presence of laboratory abnormalities, which places the participant at unacceptable risk if the participant was to participate in the study.
- •Any major surgery or planned surgery (except gastrointestinal \[GI\] surgery, as described below) within 12 weeks of study intervention administration.
- •Note: Other protocol-defined inclusion/exclusion criteria apply.
Arms & Interventions
BMS-986447
Intervention: BMS-986447
Placebo
Intervention: Placebo
Outcomes
Primary Outcomes
Number of Participants with Serious AEs (SAEs)
Time Frame: Up to 59 days
Number of Participants with Adverse Events (AEs)
Time Frame: Up to 59 days
Number of Participants with Vital Sign Abnormalities
Time Frame: Up to 35 days
Number of Participants with Clinical Laboratory Abnormalities
Time Frame: Up to 34 days
Number of Participants with Physical Examination Abnormalities
Time Frame: Up to 35 days
Number of Participants with Electrocardiogram (ECG) Abnormalities
Time Frame: Up to 34 days
Secondary Outcomes
- Maximum observed plasma concentration (Cmax)(Up to 72 hours postdose)
- Time of maximum observed plasma concentration (Tmax)(Up to 72 hours postdose)
- Apparent terminal phase half-life (T-Half)(Up to 72 hours postdose)
Study Sites (1)
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