Single and Multiple Dose Pharmacokinetics of BMS-986165 in a Randomized, Double-Blind, Placebo-Controlled Study in Healthy Chinese Subjects

NCT03956953 | Completed Phase 1 FDA Drug

• 1 other identifier: IM011-053
• Study Type: interventional
• Target: 135
• Locations: 1 country
• Sites: 1

Brief Summary

Main objective of this study is to assess BMS-986165 plasma PK following single and multiple oral doses of BMS-986165 in healthy Chinese subjects.

Conditions

Autoimmune Diseases

Outcome Measures

Primary Outcomes (17)

• Maximum Observed Plasma Concentration (Cmax) of BMS-986165

  Days 1 to 4, Day 5, and Day 19

• Time to Maximum Observed Plasma Concentration (Tmax) of BMS-986165

  Days 1 to 4, Day 5, and Day 19

• Area Under The Plasma Concentration-Time Curve From Time Zero to Time of Last Quantifiable Concentration (AUC(0-T)) of BMS-986165

  Days 1 to 4, Day 5, and Day 19

• Area Under The Plasma Concentration-Time Curve From Time Zero Extrapolated To Infinite Time (AUC(INF)) of BMS-986165

  Day 1 to Day 4

• Apparent Plasma Elimination Half-Life (T-HALF) of BMS-986165

  Days 1 to 4, Day 5, and Day 19

• Apparent Oral Total Body Clearance (CLT/F) of BMS-986165

  Days 1 to 4, Day 5, and Day 19

• Metabolic Ratio for AUC(INF) of Metabolite (BMT-153261 and BMT-158170) Over Parent (BMS-986165) - MR(AUC[INF])

  Day 1 to Day 4

• Metabolic Ratio for Cmax of Metabolite (BMT-153261 and BMT-158170) Over Parent (BMS-986165) - MR(Cmax)

  Days 1 to 4, Day 5, and Day 19

• Apparent Volume of Distribution (Vz/F) of BMS-986165

  Days 1 to 4, Day 5, and Day 19

• Time to Maximum Observed Plasma Concentration (Tmax) of BMS-986165

  Day 5 to Day 19

• Area Under the Plasma Concentration-Time Curve in a Dosing Interval (AUC(TAU)) of BMS-986165

  Day 5 and Day 19

• Effective Elimination Half-Life (T-HALFeff) of BMS-986165

  Days 1 to 4, Day 5, and Day 19

• Trough Observed Plasma Concentration (Ctrough) of BMS-986165

  Day 2 to 20

• Average Plasma Concentration at Steady State (Css-avg) of BMS-986165

  Days 1 to 4, Day 5, and Day 19

• Accumulation Index (AI) of BMS-986165

  Days 1 to 4, Day 5, and Day 19

• Metabolic Ratio for AUC(TAU) of Metabolite (BMT-153261 and BMT-158170) Over Parent (BMS-986165) - MR(AUC[TAU])

  Day 5 to Day 19

• Degree of Fluctuation (DF) of BMS-986165

  Days 1 to 4, Day 5, and Day 19

Secondary Outcomes (19)

• Number of participants with Adverse Events (AEs)

  Up to Day 31

• Number of Participants With Clinically Significant Change in Clinical Laboratory Values

  Up to Day 24

• Number of Participants With Clinically Significant Change in Vital Signs

  Up to Day 24

• Number of Participants With Clinically Significant Change in Electrocardiogram (ECG)

  Up to Day 24

• Number of Participants With Clinically Significant Change in Physical Examination

  Up to Day 24

Study Arms (4)

Group 1: BMS-986165 Dose 1

EXPERIMENTAL

Participants will receive Dose 1 on Day 1, and from Day 5 - 19.

Drug: BMS-986165

Group 2: BMS-986165 Dose 2

EXPERIMENTAL

Participants will receive Dose 2 on Day 1, and from Day 5 - 19.

Drug: BMS-986165

Group 1: Placebo Dose 1

PLACEBO COMPARATOR

Participants will receive placebo matching Dose 1 on Day 1, and from Day 5 - 19.

Other: Placebo

Group 2: Placebo Dose 2

PLACEBO COMPARATOR

Participants will receive placebo matching Dose 2 on Day 1, and from Day 5 - 19.

Other: Placebo

Interventions

BMS-986165 DRUG

Dose 1 or Dose 2 on Day 1, and from Days 5-19'

Group 1: BMS-986165 Dose 1; Group 2: BMS-986165 Dose 2

Placebo OTHER

Placebo matching Dose 1 or Dose 2 on Day 1, and from Days 5-19

Group 1: Placebo Dose 1; Group 2: Placebo Dose 2

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Signed Informed Consent.
• Healthy participants, as determined by physical examination, ECGs, and clinical laboratory and procedure determinations.
• Body mass index (BMI) of 18 to 24 kg/m2, inclusive, and total body weight \>= 50 kg.

You may not qualify if:

• History of allergy to drug class or related compounds.
• History or evidence of active infection within 7 days of study day 1.
• Drug or alcohol abuse within 6 months of study treatment administration.

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (1)

Local Institution

Beijing, Beijing Municipality, 100029, China

Location

Related Publications (1)

• Jing S, Lin Y, Dockens R, Marchisin D, He B, Girgis IG, Chimalakonda A, Murthy B, Aras U. Pharmacokinetics and Safety of the Tyrosine Kinase 2 Inhibitor Deucravacitinib in Healthy Chinese Subjects. Dermatol Ther (Heidelb). 2023 Dec;13(12):3153-3164. doi: 10.1007/s13555-023-01050-7. Epub 2023 Nov 19.

  PMID: 37981596 DERIVED

Related Links

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

MeSH Terms

Conditions

Autoimmune Diseases

Interventions

deucravacitinib

Condition Hierarchy (Ancestors)

Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: There will be two dose groups. Once the safety and tolerability up to discharge (Day 24) of Group 1, has been assessed and deemed safe; dosing for Group 2 will begin.

Study Record Dates

• First Submitted: May 17, 2019
• First Posted: May 21, 2019
• Study Start: April 4, 2019
• Primary Completion: September 25, 2019
• Study Completion: September 25, 2019
• Last Updated: June 18, 2020

Record last verified: 2020-06

Locations

CN (1)