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

Healthy Participants Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04175925
• Other study ID #: IM032-007
• Status: Completed
• Phase: Phase 1
• Start date: November 15, 2019
• Est. completion date: July 13, 2021

Study information

• Verified date: May 2022
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 171
• Est. completion date: July 13, 2021
• Est. primary completion date: July 13, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Participants

Intervention

Drug:
• BMS-986322
Specified Dose on Specified Days

Other:
• BMS-986322 Placebo
Specified Dose on Specified Days

Drug:
• famotidine
Specified Dose on Specified Days

Locations

Country	Name	City	State
United States	ICON (LPRA) - Lenexa	Lenexa	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Death		up to 12 months
Primary	Incidence of Adverse Effects (AEs)		up to 12 months
Primary	Incidence of Adverse Events leading to discontinuation		up to 12 months
Primary	Incidence of Serious Adverse Events (SAEs)		up to 12 months
Primary	Vital signs of body temperature		up to 12 months
Primary	Vital signs of blood pressure		up to 12 months
Primary	Vital signs of respiratory rate		up to 12 months
Primary	Number of Participants with abnormal physical examinations		up to 12 months
Primary	Number of clinically significant changes in Electrocardiograms (ECGs)		up to 12 months
Primary	Number of clinically significant changes in lab assessment of blood serum		up to 12 months
Primary	Number of clinically significant changes in lab assessment of urine		up to 12 months
Primary	Number of Clinically significant changes in lab assessment of blood		up to 12 months
Primary	Maximum concentration (Cmax) of BMS-986322 in Part C		up to 12 months
Primary	Time of maximum concentration (Tmax) of BMS-986322 in Part C		up to 12 months
Primary	Terminal elimination rate constant (Lambda_z) of BMS-986322 in Part C		up to 12 months
Primary	Terminal elimination half-life (T-Half) of BMS-986322 in Part C		up to 12 months
Primary	Area under the plasma concentration-time curve extrapolated to infinity [AUC(INF)] of BMS-986322 in Part C		up to 12 months
Primary	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
Primary	Apparent oral clearance (CL/F) of BMS-986322 in Part C		up to 12 months
Primary	Apparent volume of distrubution at terminal phase (Vz/F) of BMS-986322 in Part C		up to 12 months

External Links

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