Healthy Participants
Conditions
Brief summary
A Study assessing the drug levels and drug effects of variable doses of BMS-986322 in Healthy Participants compared to a placebo. The study also assesses how BMS-986322 affects the body with food and its acidity levels.
Detailed description
Recruitment temporarily on hold due to COVID-19. This is a randomized, double-blind, placebo-controlled study which will investigate the safety, tolerability, and PK of single and multiple oral doses of BMS-986322 in healthy subjects. The trial consists of three parts: Part A - a single ascending dose (SAD) safety and pharmacokinetic (PK) evaluation; Part B -a multiple ascending dose (MAD) safety, PK, and pharmacodynamic (PD) evaluation; and Part C - effect of food and pH on PK and safety.
Interventions
DRUGfamotidine
Specified Dose on Specified Days
OTHERBMS-986322 Placebo
Specified Dose on Specified Days
DRUGBMS-986322
Specified Dose on Specified Days
Sponsors
Bristol-Myers Squibb
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy Participant, as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations * Body mass index (BMI) of 18.0 kg/m\^2 to 32.0 kg/m\^2, inclusive, and body weight ≥ 50 kg, at screening * Women and men must agree to follow methods of contraception.
Exclusion criteria
* Any significant acute or chronic medical illness * History of recent infection * History of allergy to BMS-986322 or other compounds Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of Death | up to 12 months |
| Incidence of Adverse Effects (AEs) | up to 12 months |
| Incidence of Adverse Events leading to discontinuation | up to 12 months |
| Incidence of Serious Adverse Events (SAEs) | up to 12 months |
| Vital signs of body temperature | up to 12 months |
| Vital signs of blood pressure | up to 12 months |
| Vital signs of respiratory rate | up to 12 months |
| Number of Participants with abnormal physical examinations | up to 12 months |
| Number of clinically significant changes in Electrocardiograms (ECGs) | up to 12 months |
| Number of clinically significant changes in lab assessment of blood serum | up to 12 months |
| Number of clinically significant changes in lab assessment of urine | up to 12 months |
| Number of Clinically significant changes in lab assessment of blood | up to 12 months |
| Maximum concentration (Cmax) of BMS-986322 in Part C | up to 12 months |
| Time of maximum concentration (Tmax) of BMS-986322 in Part C | up to 12 months |
| Terminal elimination rate constant (Lambda_z) of BMS-986322 in Part C | up to 12 months |
| Terminal elimination half-life (T-Half) of BMS-986322 in Part C | up to 12 months |
| Area under the plasma concentration-time curve extrapolated to infinity [AUC(INF)] of BMS-986322 in Part C | up to 12 months |
| Area under the plasma concentration-time curve from time 0 to the last quantifiable concentration [AUC(0-T)] of BMS-986322 in Part C | up to 12 months |
| Apparent oral clearance (CL/F) of BMS-986322 in Part C | up to 12 months |
| Apparent volume of distrubution at terminal phase (Vz/F) of BMS-986322 in Part C | up to 12 months |
Countries
United States
Outcome results
None listed