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Completed

NCT Number: NCT03956953

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

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.

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Key information

Conditions

Autoimmune Diseases Immune System Diseases

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Local Institution

Beijing, Beijing Municipality, 100029, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BMS-986165

Drug

Dose 1 or Dose 2 on Day 1, and from Days 5-19'

Placebo

Other

Placebo matching Dose 1 or Dose 2 on Day 1, and from Days 5-19

Primary outcomes

  1. Maximum Observed Plasma Concentration (Cmax) of BMS-986165

    Time frame: Days 1 to 4, Day 5, and Day 19

  2. Time to Maximum Observed Plasma Concentration (Tmax) of BMS-986165

    Time frame: Days 1 to 4, Day 5, and Day 19

  3. Area Under The Plasma Concentration-Time Curve From Time Zero to Time of Last Quantifiable Concentration (AUC(0-T)) of BMS-986165

    Time frame: Days 1 to 4, Day 5, and Day 19

  4. Area Under The Plasma Concentration-Time Curve From Time Zero Extrapolated To Infinite Time (AUC(INF)) of BMS-986165

    Time frame: Day 1 to Day 4

  5. Apparent Plasma Elimination Half-Life (T-HALF) of BMS-986165

    Time frame: Days 1 to 4, Day 5, and Day 19

  6. Apparent Oral Total Body Clearance (CLT/F) of BMS-986165

    Time frame: Days 1 to 4, Day 5, and Day 19

  7. Metabolic Ratio for AUC(INF) of Metabolite (BMT-153261 and BMT-158170) Over Parent (BMS-986165) - MR(AUC[INF])

    Time frame: Day 1 to Day 4

  8. Metabolic Ratio for Cmax of Metabolite (BMT-153261 and BMT-158170) Over Parent (BMS-986165) - MR(Cmax)

    Time frame: Days 1 to 4, Day 5, and Day 19

  9. Apparent Volume of Distribution (Vz/F) of BMS-986165

    Time frame: Days 1 to 4, Day 5, and Day 19

  10. Time to Maximum Observed Plasma Concentration (Tmax) of BMS-986165

    Time frame: Day 5 to Day 19

  11. Area Under the Plasma Concentration-Time Curve in a Dosing Interval (AUC(TAU)) of BMS-986165

    Time frame: Day 5 and Day 19

  12. Effective Elimination Half-Life (T-HALFeff) of BMS-986165

    Time frame: Days 1 to 4, Day 5, and Day 19

  13. Trough Observed Plasma Concentration (Ctrough) of BMS-986165

    Time frame: Day 2 to 20

  14. Average Plasma Concentration at Steady State (Css-avg) of BMS-986165

    Time frame: Days 1 to 4, Day 5, and Day 19

  15. Accumulation Index (AI) of BMS-986165

    Time frame: Days 1 to 4, Day 5, and Day 19

  16. Metabolic Ratio for AUC(TAU) of Metabolite (BMT-153261 and BMT-158170) Over Parent (BMS-986165) - MR(AUC[TAU])

    Time frame: Day 5 to Day 19

  17. Degree of Fluctuation (DF) of BMS-986165

    Time frame: Days 1 to 4, Day 5, and Day 19

Secondary outcomes

  1. Number of participants with Adverse Events (AEs)

    Time frame: Up to Day 31

  2. Number of Participants With Clinically Significant Change in Clinical Laboratory Values

    Time frame: Up to Day 24

  3. Number of Participants With Clinically Significant Change in Vital Signs

    Time frame: Up to Day 24

  4. Number of Participants With Clinically Significant Change in Electrocardiogram (ECG)

    Time frame: Up to Day 24

  5. Number of Participants With Clinically Significant Change in Physical Examination

    Time frame: Up to Day 24

  6. Maximum Observed Plasma Concentration (Cmax) of Metabolites BMT-153261 and BMT-158170

    Time frame: Days 1 to 4, Day 5, and Day 19

  7. Time to Maximum Observed Plasma Concentration (Tmax) of B Metabolites BMT-153261 and BMT-158170

    Time frame: Days 1 to 4, Day 5, and Day 19

  8. 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

    Time frame: Days 1 to 4, Day 5, and Day 19

  9. Area Under The Plasma Concentration-Time Curve From Time Zero Extrapolated To Infinite Time (AUC(INF)) of Metabolites BMT-153261 and BMT-158170

    Time frame: Days 1 to 4, Day 5, and Day 19

  10. Apparent Plasma Elimination Half-Life (T-HALF) of Metabolites BMT-153261 and BMT-158170

    Time frame: Days 1 to 4, Day 5, and Day 19

  11. Area Under the Plasma Concentration-Time Curve in a Dosing Interval (AUC(TAU)) of Metabolites BMT-153261 and BMT-158170

    Time frame: Days 1 to 4, Day 5, and Day 19

  12. Effective Elimination Half-Life (T-HALFeff) of Metabolites BMT-153261 and BMT-158170

    Time frame: Days 1 to 4, Day 5, and Day 19

  13. Trough Observed Plasma Concentration (Ctrough) of Metabolites BMT-153261 and BMT-158170

    Time frame: Days 1 to 4, Day 5, and Day 19

  14. Average Plasma Concentration at Steady State (Css-avg) of Metabolites BMT-153261 and BMT-158170

    Time frame: Days 1 to 4, Day 5, and Day 19

  15. Accumulation Index (AI) of Metabolites BMT-153261 and BMT-158170

    Time frame: Days 1 to 4, Day 5, and Day 19

  16. Degree of Fluctuation (DF) of Metabolites BMT-153261 and BMT-158170

    Time frame: Days 1 to 4, Day 5, and Day 19

  17. Total Amount of Drug Recovered in Urine (URt) Following Single Oral Doses of BMS-986165

    Time frame: Day 1 to Day 5

  18. Total Percent of Administered Dose Recovered Unchanged in Urine (%URt) Following Single Oral Doses of BMS-986165

    Time frame: Day 1 to Day 5

  19. Renal Clearance (CLR) Following Single Oral Doses of BMS-986165

    Time frame: Day 1 to Day 5

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
May 21, 2019
Registry last updated
Jun 18, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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