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

Completed · Phase 1 · Has a placebo group

Conditions studied: Health Participants

In brief

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.

Key facts

Study ID

NCT04154800

Run by

Bristol-Myers Squibb

People needed

114

Starts

2019-12-06

Expected to finish

2021-08-31

Last updated by the study team

2022-01-04

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

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

Full record on ClinicalTrials.gov

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