Clinical trial NCT04949269: A Study to Evaluate the Drug Levels of Deucravacitinib From Tablets After Oral Administration in Healthy Participants
Official title: A Phase 1, Open-label, Crossover Study to Evaluate the Pharmacokinetics of Deucravacitinib (BMS-986165) Administered as Various Solid Tablet Formulations in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Participants
Keywords: Healthy Participants
Deucravacitinib
BMS-986165
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2021-07-02
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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


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

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

Primary outcomes:
measure: Maximum Observed Plasma Concentration (Cmax) of deucravacitinib
timeFrame: Up to 7 days
measure: Area Under the Concentration-time Curve from time 0 to 24 hours postdose (AUC(0-24)) of deucravacitinib
timeFrame: Up to 7 days
measure: Concentration at 24 hours of post-morning dose on Day 1 and Day 7 (C24) of deucravacitinib
timeFrame: Up to 7 days
Secondary outcomes:
measure: Incidence of non-serious Adverse Events (AEs)
timeFrame: Up to 18 days
measure: Incidence of Serious Adverse Events (SAEs)
timeFrame: Up to 30 days post discontinuation of dosing or participant's participation in the study
measure: Incidence of clinically significant changes in clinical laboratory values: Hematology tests
timeFrame: Up to 11 days
measure: Incidence of clinically significant changes in clinical laboratory values: Chemistry tests
timeFrame: Up to 11 days
measure: Incidence of clinically significant changes in clinical laboratory values: Urinalysis tests
timeFrame: Up to 11 days
measure: Incidence of clinically significant changes in vital signs: Body temperature
timeFrame: Up to 11 days
measure: Incidence of clinically significant changes in vital signs: Respiratory rate
timeFrame: Up to 11 days
measure: Incidence of clinically significant changes in vital signs: Blood pressure
timeFrame: Up to 11 days
measure: Incidence of clinically significant changes in vital signs: Heart rate
timeFrame: Up to 11 days
measure: Incidence of clinically significant changes in electrocardiogram (ECG) parameters: PR interval
timeFrame: Up to 11 days
measure: Incidence of clinically significant changes in ECG parameters: QRS
timeFrame: Up to 11 days
measure: Incidence of clinically significant changes in ECG parameters: QT interval
timeFrame: Up to 11 days
measure: Incidence of clinically significant changes in ECG parameters: QTcF
timeFrame: Up to 11 days
Other outcomes:
Locations:
city: Miami
country: United States
facility: Quotient Sciences Miami
state: Florida
city: Austin
country: United States
facility: PPD Development, LP
state: Texas
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: