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

Autoimmune Diseases Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03956953
• Other study ID #: IM011-053
• Status: Completed
• Phase: Phase 1
• 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
• 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

Related Conditions & MeSH terms

• Autoimmune Diseases

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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