Clinical trial NCT03956953: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Autoimmune Diseases
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2019-05-21
Enrollment: 135
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Maximum Observed Plasma Concentration (Cmax) of BMS-986165
timeFrame: Days 1 to 4, Day 5, and Day 19
measure: Time to Maximum Observed Plasma Concentration (Tmax) of BMS-986165
timeFrame: Days 1 to 4, Day 5, and Day 19
measure: Area Under The Plasma Concentration-Time Curve From Time Zero to Time of Last Quantifiable Concentration (AUC(0-T)) of BMS-986165
timeFrame: Days 1 to 4, Day 5, and Day 19
measure: Area Under The Plasma Concentration-Time Curve From Time Zero Extrapolated To Infinite Time (AUC(INF)) of BMS-986165
timeFrame: Day 1 to Day 4
measure: Apparent Plasma Elimination Half-Life (T-HALF) of BMS-986165
timeFrame: Days 1 to 4, Day 5, and Day 19
measure: Apparent Oral Total Body Clearance (CLT/F) of BMS-986165
timeFrame: Days 1 to 4, Day 5, and Day 19
measure: Metabolic Ratio for AUC(INF) of Metabolite (BMT-153261 and BMT-158170) Over Parent (BMS-986165) - MR(AUC[INF])
timeFrame: Day 1 to Day 4
measure: Metabolic Ratio for Cmax of Metabolite (BMT-153261 and BMT-158170) Over Parent (BMS-986165) - MR(Cmax)
timeFrame: Days 1 to 4, Day 5, and Day 19
measure: Apparent Volume of Distribution (Vz/F) of BMS-986165
timeFrame: Days 1 to 4, Day 5, and Day 19
measure: Time to Maximum Observed Plasma Concentration (Tmax) of BMS-986165
timeFrame: Day 5 to Day 19
measure: Area Under the Plasma Concentration-Time Curve in a Dosing Interval (AUC(TAU)) of BMS-986165
timeFrame: Day 5 and Day 19
measure: Effective Elimination Half-Life (T-HALFeff) of BMS-986165
timeFrame: Days 1 to 4, Day 5, and Day 19
measure: Trough Observed Plasma Concentration (Ctrough) of BMS-986165
timeFrame: Day 2 to 20
measure: Average Plasma Concentration at Steady State (Css-avg) of BMS-986165
timeFrame: Days 1 to 4, Day 5, and Day 19
measure: Accumulation Index (AI) of BMS-986165
timeFrame: Days 1 to 4, Day 5, and Day 19
measure: Metabolic Ratio for AUC(TAU) of Metabolite (BMT-153261 and BMT-158170) Over Parent (BMS-986165) - MR(AUC[TAU])
timeFrame: Day 5 to Day 19
measure: Degree of Fluctuation (DF) of BMS-986165
timeFrame: Days 1 to 4, Day 5, and Day 19
Secondary outcomes:
measure: Number of participants with Adverse Events (AEs)
timeFrame: Up to Day 31
measure: Number of Participants With Clinically Significant Change in Clinical Laboratory Values
timeFrame: Up to Day 24
measure: Number of Participants With Clinically Significant Change in Vital Signs
timeFrame: Up to Day 24
measure: Number of Participants With Clinically Significant Change in Electrocardiogram (ECG)
timeFrame: Up to Day 24
measure: Number of Participants With Clinically Significant Change in Physical Examination
timeFrame: Up to Day 24
measure: Maximum Observed Plasma Concentration (Cmax) of Metabolites BMT-153261 and BMT-158170
timeFrame: Days 1 to 4, Day 5, and Day 19
measure: Time to Maximum Observed Plasma Concentration (Tmax) of B Metabolites BMT-153261 and BMT-158170
timeFrame: Days 1 to 4, Day 5, and Day 19
measure: 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
timeFrame: Days 1 to 4, Day 5, and Day 19
measure: Area Under The Plasma Concentration-Time Curve From Time Zero Extrapolated To Infinite Time (AUC(INF)) of Metabolites BMT-153261 and BMT-158170
timeFrame: Days 1 to 4, Day 5, and Day 19
measure: Apparent Plasma Elimination Half-Life (T-HALF) of Metabolites BMT-153261 and BMT-158170
timeFrame: Days 1 to 4, Day 5, and Day 19
measure: Area Under the Plasma Concentration-Time Curve in a Dosing Interval (AUC(TAU)) of Metabolites BMT-153261 and BMT-158170
timeFrame: Days 1 to 4, Day 5, and Day 19
measure: Effective Elimination Half-Life (T-HALFeff) of Metabolites BMT-153261 and BMT-158170
timeFrame: Days 1 to 4, Day 5, and Day 19
measure: Trough Observed Plasma Concentration (Ctrough) of Metabolites BMT-153261 and BMT-158170
timeFrame: Days 1 to 4, Day 5, and Day 19
measure: Average Plasma Concentration at Steady State (Css-avg) of Metabolites BMT-153261 and BMT-158170
timeFrame: Days 1 to 4, Day 5, and Day 19
measure: Accumulation Index (AI) of Metabolites BMT-153261 and BMT-158170
timeFrame: Days 1 to 4, Day 5, and Day 19
measure: Degree of Fluctuation (DF) of Metabolites BMT-153261 and BMT-158170
timeFrame: Days 1 to 4, Day 5, and Day 19
measure: Total Amount of Drug Recovered in Urine (URt) Following Single Oral Doses of BMS-986165
timeFrame: Day 1 to Day 5
measure: Total Percent of Administered Dose Recovered Unchanged in Urine (%URt) Following Single Oral Doses of BMS-986165
timeFrame: Day 1 to Day 5
measure: Renal Clearance (CLR) Following Single Oral Doses of BMS-986165
timeFrame: Day 1 to Day 5
Other outcomes:
Locations:
city: Beijing
country: China
facility: Local Institution
state: Beijing
Study officials:
References: