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

Primary Purpose

Autoimmune Diseases

Status

Completed

Phase

Phase 1

Locations

China

Study Type

Interventional

Intervention

BMS-986165

Placebo

About this trial

This is an interventional treatment trial for Autoimmune Diseases

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Local Institution

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Arm Label

Group 1: BMS-986165 Dose 1

Group 2: BMS-986165 Dose 2

Group 1: Placebo Dose 1

Group 2: Placebo Dose 2

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

Maximum Observed Plasma Concentration (Cmax) of BMS-986165

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

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

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

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

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

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

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

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

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

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

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

Trough Observed Plasma Concentration (Ctrough) of BMS-986165

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

Accumulation Index (AI) of BMS-986165

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

Degree of Fluctuation (DF) of BMS-986165

Secondary Outcome Measures

Number of participants with Adverse Events (AEs)

Number of Participants With Clinically Significant Change in Clinical Laboratory Values

Number of Participants With Clinically Significant Change in Vital Signs

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

Number of Participants With Clinically Significant Change in Physical Examination

Maximum Observed Plasma Concentration (Cmax) of Metabolites BMT-153261 and BMT-158170

Time to Maximum Observed Plasma Concentration (Tmax) of B Metabolites BMT-153261 and BMT-158170

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

Area Under The Plasma Concentration-Time Curve From Time Zero Extrapolated To Infinite Time (AUC(INF)) of Metabolites BMT-153261 and BMT-158170

Apparent Plasma Elimination Half-Life (T-HALF) of Metabolites BMT-153261 and BMT-158170

Area Under the Plasma Concentration-Time Curve in a Dosing Interval (AUC(TAU)) of Metabolites BMT-153261 and BMT-158170

Effective Elimination Half-Life (T-HALFeff) of Metabolites BMT-153261 and BMT-158170

Trough Observed Plasma Concentration (Ctrough) of Metabolites BMT-153261 and BMT-158170

Average Plasma Concentration at Steady State (Css-avg) of Metabolites BMT-153261 and BMT-158170

Accumulation Index (AI) of Metabolites BMT-153261 and BMT-158170

Degree of Fluctuation (DF) of Metabolites BMT-153261 and BMT-158170

Total Amount of Drug Recovered in Urine (URt) Following Single Oral Doses of BMS-986165

Total Percent of Administered Dose Recovered Unchanged in Urine (%URt) Following Single Oral Doses of BMS-986165

Renal Clearance (CLR) Following Single Oral Doses of BMS-986165

Full Information

NCT ID

NCT03956953

First Posted

May 17, 2019

Last Updated

June 16, 2020

Sponsor

Bristol-Myers Squibb

1. Study Identification

Unique Protocol Identification Number

NCT03956953

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2020

Overall Recruitment Status

Completed

Study Start Date

April 4, 2019 (Actual)

Primary Completion Date

September 25, 2019 (Actual)

Study Completion Date

September 25, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Bristol-Myers Squibb

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Autoimmune Diseases

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

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

ParticipantInvestigator

Allocation

Randomized

Enrollment

135 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Group 1: BMS-986165 Dose 1

Arm Type

Experimental

Arm Description

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

Arm Title

Group 2: BMS-986165 Dose 2

Arm Type

Experimental

Arm Description

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

Arm Title

Group 1: Placebo Dose 1

Arm Type

Placebo Comparator

Arm Description

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

Arm Title

Group 2: Placebo Dose 2

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

BMS-986165

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Placebo

Intervention Description

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

Primary Outcome Measure Information:

Title

Maximum Observed Plasma Concentration (Cmax) of BMS-986165

Time Frame

Days 1 to 4, Day 5, and Day 19

Title

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

Time Frame

Days 1 to 4, Day 5, and Day 19

Title

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

Time Frame

Days 1 to 4, Day 5, and Day 19

Title

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

Time Frame

Day 1 to Day 4

Title

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

Time Frame

Days 1 to 4, Day 5, and Day 19

Title

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

Time Frame

Days 1 to 4, Day 5, and Day 19

Title

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

Time Frame

Day 1 to Day 4

Title

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

Time Frame

Days 1 to 4, Day 5, and Day 19

Title

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

Time Frame

Days 1 to 4, Day 5, and Day 19

Title

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

Time Frame

Day 5 to Day 19

Title

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

Time Frame

Day 5 and Day 19

Title

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

Time Frame

Days 1 to 4, Day 5, and Day 19

Title

Trough Observed Plasma Concentration (Ctrough) of BMS-986165

Time Frame

Day 2 to 20

Title

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

Time Frame

Days 1 to 4, Day 5, and Day 19

Title

Accumulation Index (AI) of BMS-986165

Time Frame

Days 1 to 4, Day 5, and Day 19

Title

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

Time Frame

Day 5 to Day 19

Title

Degree of Fluctuation (DF) of BMS-986165

Time Frame

Days 1 to 4, Day 5, and Day 19

Secondary Outcome Measure Information:

Title

Number of participants with Adverse Events (AEs)

Time Frame

Up to Day 31

Title

Number of Participants With Clinically Significant Change in Clinical Laboratory Values

Time Frame

Up to Day 24

Title

Number of Participants With Clinically Significant Change in Vital Signs

Time Frame

Up to Day 24

Title

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

Time Frame

Up to Day 24

Title

Number of Participants With Clinically Significant Change in Physical Examination

Time Frame

Up to Day 24

Title

Maximum Observed Plasma Concentration (Cmax) of Metabolites BMT-153261 and BMT-158170

Time Frame

Days 1 to 4, Day 5, and Day 19

Title

Time to Maximum Observed Plasma Concentration (Tmax) of B Metabolites BMT-153261 and BMT-158170

Time Frame

Days 1 to 4, Day 5, and Day 19

Title

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

Time Frame

Days 1 to 4, Day 5, and Day 19

Title

Area Under The Plasma Concentration-Time Curve From Time Zero Extrapolated To Infinite Time (AUC(INF)) of Metabolites BMT-153261 and BMT-158170

Time Frame

Days 1 to 4, Day 5, and Day 19

Title

Apparent Plasma Elimination Half-Life (T-HALF) of Metabolites BMT-153261 and BMT-158170

Time Frame

Days 1 to 4, Day 5, and Day 19

Title

Area Under the Plasma Concentration-Time Curve in a Dosing Interval (AUC(TAU)) of Metabolites BMT-153261 and BMT-158170

Time Frame

Days 1 to 4, Day 5, and Day 19

Title

Effective Elimination Half-Life (T-HALFeff) of Metabolites BMT-153261 and BMT-158170

Time Frame

Days 1 to 4, Day 5, and Day 19

Title

Trough Observed Plasma Concentration (Ctrough) of Metabolites BMT-153261 and BMT-158170

Time Frame

Days 1 to 4, Day 5, and Day 19

Title

Average Plasma Concentration at Steady State (Css-avg) of Metabolites BMT-153261 and BMT-158170

Time Frame

Days 1 to 4, Day 5, and Day 19

Title

Accumulation Index (AI) of Metabolites BMT-153261 and BMT-158170

Time Frame

Days 1 to 4, Day 5, and Day 19

Title

Degree of Fluctuation (DF) of Metabolites BMT-153261 and BMT-158170

Time Frame

Days 1 to 4, Day 5, and Day 19

Title

Total Amount of Drug Recovered in Urine (URt) Following Single Oral Doses of BMS-986165

Time Frame

Day 1 to Day 5

Title

Total Percent of Administered Dose Recovered Unchanged in Urine (%URt) Following Single Oral Doses of BMS-986165

Time Frame

Day 1 to Day 5

Title

Renal Clearance (CLR) Following Single Oral Doses of BMS-986165

Time Frame

Day 1 to Day 5

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

Local Institution

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100029

Country

China

12. IPD Sharing Statement

Links:

URL

https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html

Description

BMS Clinical Trial Information

URL

https://www.bmsstudyconnect.com/s/US/English/USenHome

Description

BMS Clinical Trial Patient Recruiting

URL

https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm

Description

FDA Safety Alerts and Recalls

Learn more about this trial

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

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