A Study to Evaluate the Drug Levels of Deucravacitinib From Tablets After Oral Administration in Healthy Participants

Completed · Phase 1

Conditions studied: Healthy Participants

In brief

The purpose of this study is to assess the drug levels of deucravacitinib after oral administration in healthy participants.

Key facts

Study ID

NCT04949269

Run by

Bristol-Myers Squibb

People needed

61

Starts

2021-07-20

Expected to finish

2022-01-03

Last updated by the study team

2022-03-11

Who can join

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

You may qualify if…

• Healthy participants, as determined by no clinically significant deviation from normal in medical history, physical examination, vital signs, 12-lead ECGs, and clinical laboratory determinations.
• Body mass index (BMI) of 18.0 to 32.0 kg/m2, inclusive, and total body weight ≥50 kg (110 lb).
• Willing and able to consume 4 units of alcohol (Part C only). Only participants with low to moderate alcohol consumption will be enrolled in Part C of this study (ie, consumption of between 1 and 21 units per week for males and between 1 and 14 units per week in females).

You may not qualify if…

• Current or recent (within 3 months or 90 days of study drug administration) clinically significant gastrointestinal disease that, in the opinion of the investigator or medical monitor, could impact upon the absorption of study drug.
• Any medical condition that presents a potential risk to the participant and/or may compromise the objectives of the study, including a history of or active liver disease.
• Clinically significant history or presence of acute or chronic bacterial, fungal, or viral infection (eg, pneumonia, septicemia) within the 3 months or 90 days prior to screening.
• Other protocol-defined inclusion/exclusion criteria apply

Where it is running

• Quotient Sciences Miami — Miami, Florida, United States
• PPD Development, LP — Austin, Texas, United States

Full record on ClinicalTrials.gov

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