A Study to Evaluate the Drug Levels of Deucravacitinib From Tablets After Oral Administration in Healthy Participants
- Registration Number
- NCT04949269
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
The purpose of this study is to assess the drug levels of deucravacitinib after oral administration in healthy participants.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 61
Inclusion Criteria
- 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).
Exclusion Criteria
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Part A Deucravacitinib - Part B Deucravacitinib - Part C Deucravacitinib - Part C Famotidine - Part D Deucravacitinib -
- Primary Outcome Measures
Name Time Method Maximum Observed Plasma Concentration (Cmax) of deucravacitinib Up to 7 days Area Under the Concentration-time Curve from time 0 to 24 hours postdose (AUC(0-24)) of deucravacitinib Up to 7 days Concentration at 24 hours of post-morning dose on Day 1 and Day 7 (C24) of deucravacitinib Up to 7 days
- Secondary Outcome Measures
Name Time Method Incidence of non-serious Adverse Events (AEs) Up to 18 days Incidence of Serious Adverse Events (SAEs) Up to 30 days post discontinuation of dosing or participant's participation in the study Incidence of clinically significant changes in vital signs: Blood pressure Up to 11 days Incidence of clinically significant changes in vital signs: Heart rate Up to 11 days Incidence of clinically significant changes in electrocardiogram (ECG) parameters: PR interval Up to 11 days PR interval is the time from the onset of the P wave to the start of the QRS complex
Incidence of clinically significant changes in ECG parameters: QT interval Up to 11 days The QT interval is the time from the start of the Q wave to the end of the T wave
Incidence of clinically significant changes in ECG parameters: QTcF Up to 11 days QTcF = Corrected QT interval using the Fridericia formula. QT interval is the time from the start of the Q wave to the end of the T wave
Incidence of clinically significant changes in clinical laboratory values: Hematology tests Up to 11 days Incidence of clinically significant changes in clinical laboratory values: Urinalysis tests Up to 11 days Incidence of clinically significant changes in vital signs: Respiratory rate Up to 11 days Incidence of clinically significant changes in ECG parameters: QRS Up to 11 days QRS can be defined as the electrical impulse as it spreads through the ventricles, indicating ventricular depolarization
Incidence of clinically significant changes in clinical laboratory values: Chemistry tests Up to 11 days Incidence of clinically significant changes in vital signs: Body temperature Up to 11 days
Trial Locations
- Locations (2)
Quotient Sciences Miami
🇺🇸Miami, Florida, United States
PPD Development, LP
🇺🇸Austin, Texas, United States