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

Healthy Participants Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04949269
• Other study ID #: IM011-120
• Status: Completed
• Phase: Phase 1
• Start date: July 20, 2021
• Est. completion date: January 3, 2022

Study information

• Verified date: February 2022
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: January 3, 2022
• Est. primary completion date: January 3, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Participants

Intervention

Drug:
• Deucravacitinib
Specified dose on specified days
• Famotidine
Specified dose on specified days

Locations

Country	Name	City	State
United States	PPD Development, LP	Austin	Texas
United States	Quotient Sciences Miami	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum Observed Plasma Concentration (Cmax) of deucravacitinib		Up to 7 days
Primary	Area Under the Concentration-time Curve from time 0 to 24 hours postdose (AUC(0-24)) of deucravacitinib		Up to 7 days
Primary	Concentration at 24 hours of post-morning dose on Day 1 and Day 7 (C24) of deucravacitinib		Up to 7 days
Secondary	Incidence of non-serious Adverse Events (AEs)		Up to 18 days
Secondary	Incidence of Serious Adverse Events (SAEs)		Up to 30 days post discontinuation of dosing or participant's participation in the study
Secondary	Incidence of clinically significant changes in clinical laboratory values: Hematology tests		Up to 11 days
Secondary	Incidence of clinically significant changes in clinical laboratory values: Chemistry tests		Up to 11 days
Secondary	Incidence of clinically significant changes in clinical laboratory values: Urinalysis tests		Up to 11 days
Secondary	Incidence of clinically significant changes in vital signs: Body temperature		Up to 11 days
Secondary	Incidence of clinically significant changes in vital signs: Respiratory rate		Up to 11 days
Secondary	Incidence of clinically significant changes in vital signs: Blood pressure		Up to 11 days
Secondary	Incidence of clinically significant changes in vital signs: Heart rate		Up to 11 days
Secondary	Incidence of clinically significant changes in electrocardiogram (ECG) parameters: PR interval	PR interval is the time from the onset of the P wave to the start of the QRS complex	Up to 11 days
Secondary	Incidence of clinically significant changes in ECG parameters: QRS	QRS can be defined as the electrical impulse as it spreads through the ventricles, indicating ventricular depolarization	Up to 11 days
Secondary	Incidence of clinically significant changes in ECG parameters: QT interval	The QT interval is the time from the start of the Q wave to the end of the T wave	Up to 11 days
Secondary	Incidence of clinically significant changes in ECG parameters: QTcF	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	Up to 11 days

External Links

•   BMS Clinical Trial Information
•   BMS Clinical Trial Patient Recruiting
•   FDA Safety Alerts and Recalls
•   Investigator Inquiry Form