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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03956953
Other study ID # IM011-053
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date April 4, 2019
Est. completion date September 25, 2019

Study information

Verified date June 2020
Source Bristol-Myers Squibb
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 135
Est. completion date September 25, 2019
Est. primary completion date September 25, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 45 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
BMS-986165
Dose 1 or Dose 2 on Day 1, and from Days 5-19'
Other:
Placebo
Placebo matching Dose 1 or Dose 2 on Day 1, and from Days 5-19

Locations

Country Name City State
China Local Institution Beijing Beijing

Sponsors (1)

Lead Sponsor Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

China, 

Outcome

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