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

• Sponsor: Bristol-Myers Squibb (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04949269
• Collaborator: (none)
• Enrollment: 61
• Locations: 2
• Arms: 4
• Actual Duration (Months): 5.5
• Patients Per Site: 30.5
• Patients Per Site Per Month: 5.6

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Healthy Participants	Drug: Deucravacitinib; Drug: Famotidine	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 61 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• 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
• Actual Study Start Date: Jul 20, 2021
• Actual Primary Completion Date: Jan 3, 2022
• Actual Study Completion Date: Jan 3, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Part A	Drug: Deucravacitinib; Specified dose on specified days; Other Names: BMS-986165
Experimental: Part B	Drug: Deucravacitinib; Specified dose on specified days; Other Names: BMS-986165
Experimental: Part C	Drug: Deucravacitinib; Specified dose on specified days; Other Names: BMS-986165 ; Drug: Famotidine; Specified dose on specified days; Other Names: Pepcid
Experimental: Part D	Drug: Deucravacitinib; Specified dose on specified days; Other Names: BMS-986165

Outcome Measures

Primary Outcome Measures

1. Maximum Observed Plasma Concentration (Cmax) of deucravacitinib [Up to 7 days]

2. Area Under the Concentration-time Curve from time 0 to 24 hours postdose (AUC(0-24)) of deucravacitinib [Up to 7 days]

3. Concentration at 24 hours of post-morning dose on Day 1 and Day 7 (C24) of deucravacitinib [Up to 7 days]

Secondary Outcome Measures

1. Incidence of non-serious Adverse Events (AEs) [Up to 18 days]

2. Incidence of Serious Adverse Events (SAEs) [Up to 30 days post discontinuation of dosing or participant's participation in the study]

3. Incidence of clinically significant changes in clinical laboratory values: Hematology tests [Up to 11 days]

4. Incidence of clinically significant changes in clinical laboratory values: Chemistry tests [Up to 11 days]

5. Incidence of clinically significant changes in clinical laboratory values: Urinalysis tests [Up to 11 days]

6. Incidence of clinically significant changes in vital signs: Body temperature [Up to 11 days]

7. Incidence of clinically significant changes in vital signs: Respiratory rate [Up to 11 days]

8. Incidence of clinically significant changes in vital signs: Blood pressure [Up to 11 days]

9. Incidence of clinically significant changes in vital signs: Heart rate [Up to 11 days]

10. 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

11. 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

12. 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

13. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Quotient Sciences Miami	Miami	Florida	United States	33126
2	PPD Development, LP	Austin	Texas	United States	78744

Sponsors and Collaborators

• Bristol-Myers Squibb

Investigators

• Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

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

Publications

None provided.

• Responsible Party: Bristol-Myers Squibb
• ClinicalTrials.gov Identifier: NCT04949269
• Other Study ID Numbers: IM011-120
• First Posted: Jul 2, 2021
• Last Update Posted: Mar 11, 2022
• Last Verified: Feb 1, 2022

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Bristol-Myers Squibb: Healthy Participants; Deucravacitinib; BMS-986165
• Additional relevant MeSH terms: BMS-986165; Famotidine

Study Results

No Results Posted as of Mar 11, 2022