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

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 1

Conditions: Health Participants

Treatments: Other: BMS-986209 Placebo; Drug: Diltiazem; Drug: BMS-986209; Drug: Itraconazole

Study type: Interventional

Funder types: Industry

Identifiers

NCT04154800

CV017-003

Details and patient eligibility

About

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.

Enrollment: 114 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Quadruple Blind

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114 participants in 5 patient groups

Part A:SAD

Experimental group

Description:

Single Ascending Dose

Treatment:

Drug: BMS-986209

Part B: MAD

Experimental group

Description:

Multiple Ascending Dose

Treatment:

Drug: BMS-986209

Part C: DDI

Experimental group

Description:

Drug-Drug Interaction

Treatment:

Drug: Diltiazem

Drug: Itraconazole

Drug: BMS-986209

Part A (SAD) Placebo

Experimental group

Treatment:

Other: BMS-986209 Placebo

Part B (MAD) Placebo

Experimental group

Treatment:

Other: BMS-986209 Placebo