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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Autoimmune Diseases

Intervention / Treatment
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* Drug: BMS-986165
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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.
Masking: Double


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | Measure Description | 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 |