A Study Assessing the Drug Levels, Drug Effects, and Safety of BMS-986322 in Healthy Participants

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy Participants
• Intervention / Treatment: Drug: BMS-986322; Other: BMS-986322 Placebo; Drug: famotidine

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.

• Study Type: Interventional
• Enrollment (Actual): 171
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Kansas
    • Lenexa, Kansas, United States, 66219
      • ICON (LPRA) - Lenexa

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 56 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part A: BMS-986322	Drug: BMS-986322; Specified Dose on Specified Days; Other: BMS-986322 Placebo; Specified Dose on Specified Days
Experimental: Part B: BMS-986322 Placebo	Drug: BMS-986322; Specified Dose on Specified Days; Other: BMS-986322 Placebo; Specified Dose on Specified Days
Experimental: Part C: BMS-986322 with famotidine	Drug: BMS-986322; Specified Dose on Specified Days; Drug: famotidine; Specified Dose on Specified Days

What is the study measuring?

Primary Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb

Publications and helpful links

Helpful Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting
• Investigator Inquiry Form
• FDA Safety Alerts and Recalls

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2019
• Primary Completion (Actual): July 13, 2021
• Study Completion (Actual): July 13, 2021

Study Registration Dates

• First Submitted: November 13, 2019
• First Submitted That Met QC Criteria: November 21, 2019
• First Posted (Actual): November 25, 2019

Study Record Updates

• Last Update Posted (Actual): May 31, 2022
• Last Update Submitted That Met QC Criteria: May 26, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Gastrointestinal Agents; Anti-Ulcer Agents; Histamine Antagonists; Histamine Agents; Histamine H2 Antagonists; Famotidine
• Other Study ID Numbers: IM032-007

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No