A Study to Evaluate the Safety, Tolerability, Drug Levels and Drug Effects of Single and Multiple Doses of BMS-986209 in Healthy Participants

A First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Doses of BMS-986209 in Healthy Participants

The purpose of this study is to investigate the safety and tolerability of BMS-986209 in healthy participants. The first-in-human study is designed in 3 parts that vary based on duration and food effect.

Study Overview

• Status: Completed
• Conditions: Health Participants
• Intervention / Treatment: Drug: BMS-986209; Drug: Itraconazole; Drug: Diltiazem; Other: BMS-986209 Placebo

• Study Type: Interventional
• Enrollment (Actual): 114
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Texas
    • Austin, Texas, United States, 78744
      • PPD Development, LP

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 53 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com.

Inclusion Criteria:

• Healthy male and female participants (not of childbearing potential) as determined by no deviation considered significant by the investigator from normal in medical history, physical examination, 12-lead ECG measurements, and clinical laboratory determinations
• Women and men must agree to follow specific methods of contraception if applicable.
• Body mass index (BMI) 18.0 to 32.0 kg/m2, inclusive. BMI = weight (kg)/(height [m])2 for participants

Exclusion Criteria:

• Women who are of childbearing potential
• Women who are breastfeeding
• Any acute or chronic medical illness
• History of dizziness and/or recurrent headaches (ie, daily headaches lasting for a 1-week duration in the last month prior to study treatment administration)
• History of heart disease or conduction disorders
• Head injury in the last 2 years, intracranial tumor, or aneurysm
• Known abdominal aneurysm
• Current or history of rectal bleeding, hematemesis, or hematuria

Other protocol-defined inclusion/exclusion criteria apply

Study Plan

How is the study designed?

Design Details

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

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part A:SAD; Single Ascending Dose	Drug: BMS-986209; Specified Dose on Specified Days
Experimental: Part B: MAD; Multiple Ascending Dose	Drug: BMS-986209; Specified Dose on Specified Days
Experimental: Part C: DDI; Drug-Drug Interaction	Drug: BMS-986209; Specified Dose on Specified Days; Drug: Itraconazole; Specified Dose on Specified Days; Drug: Diltiazem; Specified Dose on Specified Days
Experimental: Part A (SAD) Placebo	Other: BMS-986209 Placebo; Specified Dose on Specified Days
Experimental: Part B (MAD) Placebo	Other: BMS-986209 Placebo; Specified Dose on Specified Days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence of Adverse Events (AEs) including bleeding	Up to 18 days
Incidence of serious AEs (SAEs)	Up to 44 days
Incidence of AEs leading to discontinuation	Up to 18 days
Incidence of clinically significant changes in vital signs: Body temperature	Up to 18 days
Incidence of clinically significant changes in vital signs: Respiratory Rate	Up to 18 days
Incidence of clinically significant changes in vital signs: Seated blood pressure	Up to 18 days
Incidence of clinically significant changes in vital signs: Resting pulse rate	Up to 18 days
Incidence of clinically significant changes in electrocardiogram (ECG) parameters	Up to 18 days
Incidence of clinically significant changes in clinical laboratory tests: Hematology tests	Up to 16 days
Incidence of clinically significant changes in clinical laboratory tests: Coagulation tests	Up to 16 days
Incidence of clinically significant changes in clinical laboratory tests: Serum Chemistry tests	Up to 16 days
Incidence of clinically significant changes in clinical laboratory tests: Urinalysis tests	Up to 16 days
Incidence of clinically significant changes in clinical laboratory tests: Serology tests	Up to 16 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Incidence of Adverse Events (AEs) including bleeding	Up to 18 days
Incidence of serious AEs (SAEs)	Up to 44 days
Incidence of AEs leading to discontinuation	Up to 18 days
Incidence of clinically significant changes in vital signs: Body temperature	Up to 18 days
Incidence of clinically significant changes in vital signs: Respiratory Rate	Up to 18 days
Incidence of clinically significant changes in vital signs: Seated blood pressure	Up to 18 days
Incidence of clinically significant changes in vital signs: Resting pulse rate	Up to 18 days
Incidence of clinically significant changes in electrocardiogram (ECG) parameters	Up to 18 days
Incidence of clinically significant changes in clinical laboratory tests: Hematology tests	Up to 16 days
Incidence of clinically significant changes in clinical laboratory tests: Coagulation tests	Up to 16 days
Incidence of clinically significant changes in clinical laboratory tests: Serum Chemistry tests	Up to 16 days
Incidence of clinically significant changes in clinical laboratory tests: Urinalysis tests	Up to 16 days
Incidence of clinically significant changes in clinical laboratory tests: Serology tests	Up to 16 days
Maximum observed plasma concentration (Cmax) of BMS-986209	Up to 18 days
Time of Maximum observed plasma concentration (Tmax) of BMS-986209	Up to 18 days
Terminal plasma half-life (T-Half) of BMS-986209	Up to 18 days
Percent change from baseline in plasma activated partial thromboplastin time (aPTT) levels	Up to 16 days
Percent change from baseline in factor XI (FXI) clotting activity	Up to 16 days

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): December 6, 2019
• Primary Completion (Actual): August 31, 2021
• Study Completion (Actual): August 31, 2021

Study Registration Dates

• First Submitted: November 5, 2019
• First Submitted That Met QC Criteria: November 5, 2019
• First Posted (Actual): November 7, 2019

Study Record Updates

• Last Update Posted (Actual): January 4, 2022
• Last Update Submitted That Met QC Criteria: December 14, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: Healthy Participants
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Vasodilator Agents; Anti-Infective Agents; Enzyme Inhibitors; Hormones, Hormone Substitutes, and Hormone Antagonists; Membrane Transport Modulators; Cytochrome P-450 CYP3A Inhibitors; Cytochrome P-450 Enzyme Inhibitors; Hormone Antagonists; Calcium-Regulating Hormones and Agents; Antifungal Agents; Steroid Synthesis Inhibitors; Calcium Channel Blockers; 14-alpha Demethylase Inhibitors; Itraconazole; Diltiazem
• Other Study ID Numbers: CV017-003

Drug and device information, study documents

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