Healthy Participants
Conditions
Keywords
Healthy Participants, BMS-986172
Brief summary
The purpose of this study is to evaluate the safety, tolerability and drug levels of BMS-986172 and evaluate the effects of food on BMS-986172 absorption.
Interventions
DRUGBMS-986172
Specified dose on specified days
OTHERPlacebo
Specified dose on specified days
Sponsors
Bristol-Myers Squibb
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy participants as determined by no clinically significant deviation from normal in medical history, physical examination, vital signs, ECG, and clinical laboratory results as determined by the investigator or designee. * Participants in Part C must be first-generation Japanese participants. For the purpose of this study, first-generation Japanese is defined as native Japanese or first-generation Japanese living outside of Japan for \<10 years. * BMI of ≥ 18 kg/m2 to ≤ 40.0 kg/m2, inclusive, at screening, except for high BMI cohort participants (Part B) which will be restricted to a BMI range of ≥ 30 kg/m2 to ≤ 40.0 kg/m2.
Exclusion criteria
* Inability to tolerate the oral lipid meal or the testing conditions on Day -1, including but not limited to: bloating, nausea, vomiting, diarrhea, pain, or any discomfort due to oral lipid meal. * 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, including active, or history of, liver disease, or intestinal disorder including irritable bowel syndrome. * History or presence of malignancy including hematological malignancies; participants with a history of basal cell or squamous cell carcinoma that has been treated with no evidence of recurrence within 5 years will be allowed for inclusion, as judged by the investigator or designee. * Any significant acute or chronic medical illness. * History of SARS-CoV-2 infection (either suspected or confirmed) within 3 months prior to signing consent * Participants who have received a SARS-CoV-2 vaccine approved for Emergency Use Authorization by the US FDA that is not live attenuated may be considered for enrollment Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of clinically significant changes in ECG parameters: QTcF | Up to 28 days | QTcF = Corrected QT interval using the Fridericia formula. QT interval is the time from the start of the Q wave to the end of the T wave |
| Incidence of clinically significant changes in clinical laboratory values: Chemistry tests | Up to 28 days | — |
| Incidence of clinically significant changes in clinical laboratory values: Urinalysis tests | Up to 28 days | — |
| Incidence of clinically significant changes in clinical laboratory values: Serology tests | Up to 28 days | — |
| Incidence of non-serious Adverse Events (AEs) | Up to 35 days | — |
| Incidence of Serious Adverse Events (SAEs) | Up to 35 days | — |
| Incidence of AEs leading to discontinuation of study treatment | Up to 35 days | — |
| Incidence of clinically significant changes in vital signs: Body temperature | Up to 28 days | — |
| Incidence of clinically significant changes in vital signs: Respiratory rate | Up to 28 days | — |
| Incidence of clinically significant changes in vital signs: Blood pressure | Up to 28 days | — |
| Incidence of clinically significant changes in vital signs: Heart rate | Up to 28 days | — |
| Incidence of clinically significant changes in physical examination | Up to 28 days | — |
| Incidence of clinically significant changes in clinical laboratory values: Hematology tests | Up to 28 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Maximum observed plasma concentration (Cmax) | Up to 28 days |
| Area under the plasma concentration-time curve from time zero to time of the last quantifiable concentration (AUC(0-T)) | Up to 28 days |
| Plasma concentrations of BMS-986172 | Up to 28 days |
Countries
United States
Outcome results
None listed