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

Phase 1

Completed

• Conditions: Autoimmune Diseases
• Interventions: Drug: BMS-986165; Other: Placebo

• Registration Number: NCT03956953
• Lead Sponsor: Bristol-Myers Squibb

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2019-04-04
• Study First Submitted: 2019-05-17
• Study First Submitted QC: 2019-05-17
• Study First Posted: 2019-05-21
• Primary Completion: 2019-09-25
• Study Completion: 2019-09-25
• Status Verified: 2020-06
• Last Update Submitted: 2020-06-16
• Last Update Posted: 2020-06-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 135

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1: BMS-986165 Dose 1	BMS-986165	Participants will receive Dose 1 on Day 1, and from Day 5 - 19.
Group 2: BMS-986165 Dose 2	BMS-986165	Participants will receive Dose 2 on Day 1, and from Day 5 - 19.
Group 1: Placebo Dose 1	Placebo	Participants will receive placebo matching Dose 1 on Day 1, and from Day 5 - 19.
Group 2: Placebo Dose 2	Placebo	Participants will receive placebo matching Dose 2 on Day 1, and from Day 5 - 19.

Primary Outcome Measures

Name	Time	Method
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
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	Day 5 to 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
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
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

Name	Time	Method
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
Number of Participants With Clinically Significant Change in Electrocardiogram (ECG)	Up to Day 24
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
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

Trial Locations

Locations (1)

Local Institution; 🇨🇳 Beijing, Beijing, China