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

A Randomized, Double-Blind, Placebo-Controlled, Single- And Multiple-Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of BMS-986165 in Healthy Chinese Subjects

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.

Study Overview

• Status: Completed
• Conditions: Autoimmune Diseases
• Intervention / Treatment: Drug: BMS-986165; Other: Placebo

• Study Type: Interventional
• Enrollment (Actual): 135
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100029
      • Local Institution

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Other protocol defined inclusion/exclusion criteria could apply

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1: BMS-986165 Dose 1; Participants will receive Dose 1 on Day 1, and from Day 5 - 19.	Drug: BMS-986165; Dose 1 or Dose 2 on Day 1, and from Days 5-19'
Experimental: Group 2: BMS-986165 Dose 2; Participants will receive Dose 2 on Day 1, and from Day 5 - 19.	Drug: BMS-986165; Dose 1 or Dose 2 on Day 1, and from Days 5-19'
Placebo Comparator: Group 1: Placebo Dose 1; Participants will receive placebo matching Dose 1 on Day 1, and from Day 5 - 19.	Other: Placebo; Placebo matching Dose 1 or Dose 2 on Day 1, and from Days 5-19
Placebo Comparator: Group 2: Placebo Dose 2; Participants will receive placebo matching Dose 2 on Day 1, and from Day 5 - 19.	Other: Placebo; Placebo matching Dose 1 or Dose 2 on Day 1, and from Days 5-19

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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
Maximum Observed Plasma Concentration (Cmax) of Metabolites BMT-153261 and BMT-158170	Days 1 to 4, Day 5, and Day 19
Time to Maximum Observed Plasma Concentration (Tmax) of B Metabolites BMT-153261 and BMT-158170	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 Metabolites BMT-153261 and BMT-158170	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 Metabolites BMT-153261 and BMT-158170	Days 1 to 4, Day 5, and Day 19
Apparent Plasma Elimination Half-Life (T-HALF) of Metabolites BMT-153261 and BMT-158170	Days 1 to 4, Day 5, and Day 19
Area Under the Plasma Concentration-Time Curve in a Dosing Interval (AUC(TAU)) of Metabolites BMT-153261 and BMT-158170	Days 1 to 4, Day 5, and Day 19
Effective Elimination Half-Life (T-HALFeff) of Metabolites BMT-153261 and BMT-158170	Days 1 to 4, Day 5, and Day 19
Trough Observed Plasma Concentration (Ctrough) of Metabolites BMT-153261 and BMT-158170	Days 1 to 4, Day 5, and Day 19
Average Plasma Concentration at Steady State (Css-avg) of Metabolites BMT-153261 and BMT-158170	Days 1 to 4, Day 5, and Day 19
Accumulation Index (AI) of Metabolites BMT-153261 and BMT-158170	Days 1 to 4, Day 5, and Day 19
Degree of Fluctuation (DF) of Metabolites BMT-153261 and BMT-158170	Days 1 to 4, Day 5, and Day 19
Total Amount of Drug Recovered in Urine (URt) Following Single Oral Doses of BMS-986165	Day 1 to Day 5
Total Percent of Administered Dose Recovered Unchanged in Urine (%URt) Following Single Oral Doses of BMS-986165	Day 1 to Day 5
Renal Clearance (CLR) Following Single Oral Doses of BMS-986165	Day 1 to Day 5

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): April 4, 2019
• Primary Completion (Actual): September 25, 2019
• Study Completion (Actual): September 25, 2019

Study Registration Dates

• First Submitted: May 17, 2019
• First Submitted That Met QC Criteria: May 17, 2019
• First Posted (Actual): May 21, 2019

Study Record Updates

• Last Update Posted (Actual): June 18, 2020
• Last Update Submitted That Met QC Criteria: June 16, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Dermatologic Agents; Protein Kinase Inhibitors; BMS-986165
• Other Study ID Numbers: IM011-053

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes