ICON (LPRA) - Lenexa
Lenexa, Kansas, 66219, United States
Completed
NCT Number: NCT04175925
A Study Assessing the Drug Levels, Drug Effects, and Safety of BMS-986322 in Healthy Participants
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.
Completed
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Notify MeKey information
Conditions
Age range
18 year–60 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 1
Primary location
About this study
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.
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
BMS-986322
DrugSpecified Dose on Specified Days
BMS-986322 Placebo
OtherSpecified Dose on Specified Days
Famotidine
DrugSpecified Dose on Specified Days
Primary outcomes
-
Incidence of Death
Time frame: up to 12 months
-
Incidence of Adverse Effects (AEs)
Time frame: up to 12 months
-
Incidence of Adverse Events leading to discontinuation
Time frame: up to 12 months
-
Incidence of Serious Adverse Events (SAEs)
Time frame: up to 12 months
-
Vital signs of body temperature
Time frame: up to 12 months
-
Vital signs of blood pressure
Time frame: up to 12 months
-
Vital signs of respiratory rate
Time frame: up to 12 months
-
Number of Participants with abnormal physical examinations
Time frame: up to 12 months
-
Number of clinically significant changes in Electrocardiograms (ECGs)
Time frame: up to 12 months
-
Number of clinically significant changes in lab assessment of blood serum
Time frame: up to 12 months
-
Number of clinically significant changes in lab assessment of urine
Time frame: up to 12 months
-
Number of Clinically significant changes in lab assessment of blood
Time frame: up to 12 months
-
Maximum concentration (Cmax) of BMS-986322 in Part C
Time frame: up to 12 months
-
Time of maximum concentration (Tmax) of BMS-986322 in Part C
Time frame: up to 12 months
-
Terminal elimination rate constant (Lambda_z) of BMS-986322 in Part C
Time frame: up to 12 months
-
Terminal elimination half-life (T-Half) of BMS-986322 in Part C
Time frame: up to 12 months
-
Area under the plasma concentration-time curve extrapolated to infinity [AUC(INF)] of BMS-986322 in Part C
Time frame: 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
Time frame: up to 12 months
-
Apparent oral clearance (CL/F) of BMS-986322 in Part C
Time frame: up to 12 months
-
Apparent volume of distrubution at terminal phase (Vz/F) of BMS-986322 in Part C
Time frame: up to 12 months
Sponsors and collaborators
Lead sponsor
Bristol-Myers Squibb
Industry
Registry information
Official study 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
Important dates
- Study start
- 2019
- Primary completion
- 2021
- Study completion
- 2021
- First posted
- Nov 25, 2019
- Registry last updated
- May 31, 2022
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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