A Study Assessing the Drug Levels, Drug Effects, and Safety of BMS-986322 in Healthy Participants
- Conditions
- Healthy Participants
- Interventions
- Registration Number
- NCT04175925
- Lead Sponsor
- Bristol-Myers Squibb
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 171
- 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.
- Any significant acute or chronic medical illness
- History of recent infection
- History of allergy to BMS-986322 or other compounds
Other protocol-defined inclusion/exclusion criteria could apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Part C: BMS-986322 with famotidine famotidine - Part A: BMS-986322 BMS-986322 Placebo - Part B: BMS-986322 Placebo BMS-986322 - Part B: BMS-986322 Placebo BMS-986322 Placebo - Part C: BMS-986322 with famotidine BMS-986322 - Part A: BMS-986322 BMS-986322 -
- Primary Outcome Measures
Name Time Method Vital signs of blood pressure up to 12 months Incidence of Serious Adverse Events (SAEs) up to 12 months Vital signs of body temperature up to 12 months Number of clinically significant changes in lab assessment of urine 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 from time 0 to the last quantifiable concentration [AUC(0-T)] of BMS-986322 in Part C up to 12 months Incidence of Death up to 12 months Number of clinically significant changes in Electrocardiograms (ECGs) 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 Incidence of Adverse Effects (AEs) up to 12 months Incidence of Adverse Events leading to discontinuation 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 blood up to 12 months Maximum concentration (Cmax) 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 Apparent volume of distrubution at terminal phase (Vz/F) of BMS-986322 in Part C up to 12 months Vital signs of respiratory rate up to 12 months Number of Participants with abnormal physical examinations up to 12 months Time of maximum concentration (Tmax) 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
ICON (LPRA) - Lenexa
🇺🇸Lenexa, Kansas, United States