Autoimmune Diseases
Conditions
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.
Interventions
DRUGBMS-986165
Dose 1 or Dose 2 on Day 1, and from Days 5-19'
OTHERPlacebo
Placebo matching Dose 1 or Dose 2 on Day 1, and from Days 5-19
Sponsors
Bristol-Myers Squibb
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
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/
Design outcomes
Primary
| 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 |
| 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
| Measure | Time frame |
|---|---|
| Total Amount of Drug Recovered in Urine (URt) Following Single Oral Doses of BMS-986165 | Day 1 to Day 5 |
| 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 |
| Renal Clearance (CLR) 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 |
| 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 |
| Effective Elimination Half-Life (T-HALFeff) 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 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 |
| 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 |
Countries
China
Outcome results
None listed