Clinical trial NCT04175925: A Study Assessing the Drug Levels, Drug Effects, and Safety of BMS-986322 in Healthy Participants
Official title: A Double-blind, Placebo-controlled, Randomized, Single and Multiple Ascending Dose Study of the Safety, Pharmacokinetics, and Pharmacodynamics of BMS-986322 in Healthy Participants Including an Open-label Assessment of Food and pH Effects on Relative Bioavailability of BMS-986322
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Participants
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2019-11-25
Enrollment: 171
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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/exclusion criteria could apply.

Primary outcomes:
measure: Incidence of Death
timeFrame: up to 12 months
measure: Incidence of Adverse Effects (AEs)
timeFrame: up to 12 months
measure: Incidence of Adverse Events leading to discontinuation
timeFrame: up to 12 months
measure: Incidence of Serious Adverse Events (SAEs)
timeFrame: up to 12 months
measure: Vital signs of body temperature
timeFrame: up to 12 months
measure: Vital signs of blood pressure
timeFrame: up to 12 months
measure: Vital signs of respiratory rate
timeFrame: up to 12 months
measure: Number of Participants with abnormal physical examinations
timeFrame: up to 12 months
measure: Number of clinically significant changes in Electrocardiograms (ECGs)
timeFrame: up to 12 months
measure: Number of clinically significant changes in lab assessment of blood serum
timeFrame: up to 12 months
measure: Number of clinically significant changes in lab assessment of urine
timeFrame: up to 12 months
measure: Number of Clinically significant changes in lab assessment of blood
timeFrame: up to 12 months
measure: Maximum concentration (Cmax) of BMS-986322 in Part C
timeFrame: up to 12 months
measure: Time of maximum concentration (Tmax) of BMS-986322 in Part C
timeFrame: up to 12 months
measure: Terminal elimination rate constant (Lambda_z) of BMS-986322 in Part C
timeFrame: up to 12 months
measure: Terminal elimination half-life (T-Half) of BMS-986322 in Part C
timeFrame: up to 12 months
measure: Area under the plasma concentration-time curve extrapolated to infinity [AUC(INF)] of BMS-986322 in Part C
timeFrame: up to 12 months
measure: Area under the plasma concentration-time curve from time 0 to the last quantifiable concentration [AUC(0-T)] of BMS-986322 in Part C
timeFrame: up to 12 months
measure: Apparent oral clearance (CL/F) of BMS-986322 in Part C
timeFrame: up to 12 months
measure: Apparent volume of distrubution at terminal phase (Vz/F) of BMS-986322 in Part C
timeFrame: up to 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Lenexa
country: United States
facility: ICON (LPRA) - Lenexa
state: Kansas
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: