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

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ClinicalTrials.gov Identifier: NCT03956953
Recruitment Status : Completed
First Posted : May 21, 2019
Last Update Posted : October 28, 2019
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Tracking Information
First Submitted Date  ICMJE May 17, 2019
First Posted Date  ICMJE May 21, 2019
Last Update Posted Date October 28, 2019
Actual Study Start Date  ICMJE April 14, 2019
Actual Primary Completion Date September 25, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 17, 2019)
  • Maximum Observed Plasma Concentration (Cmax) of BMS-986165 [ Time Frame: Days 1 to 4, Day 5, and Day 19 ]
  • Time to Maximum Observed Plasma Concentration (Tmax) of BMS-986165 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Day 1 to Day 4 ]
  • Apparent Plasma Elimination Half-Life (T-HALF) of BMS-986165 [ Time Frame: Days 1 to 4, Day 5, and Day 19 ]
  • Apparent Oral Total Body Clearance (CLT/F) of BMS-986165 [ Time Frame: 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]) [ Time Frame: Day 1 to Day 4 ]
  • 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 ]
  • Apparent Volume of Distribution (Vz/F) of BMS-986165 [ Time Frame: Days 1 to 4, Day 5, and Day 19 ]
  • Time to Maximum Observed Plasma Concentration (Tmax) of BMS-986165 [ Time Frame: Day 5 to Day 19 ]
  • Area Under the Plasma Concentration-Time Curve in a Dosing Interval (AUC(TAU)) of BMS-986165 [ Time Frame: Day 5 and Day 19 ]
  • Effective Elimination Half-Life (T-HALFeff) of BMS-986165 [ Time Frame: Days 1 to 4, Day 5, and Day 19 ]
  • Trough Observed Plasma Concentration (Ctrough) of BMS-986165 [ Time Frame: Day 2 to 20 ]
  • Average Plasma Concentration at Steady State (Css-avg) of BMS-986165 [ Time Frame: Days 1 to 4, Day 5, and Day 19 ]
  • Accumulation Index (AI) of BMS-986165 [ Time Frame: 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]) [ Time Frame: Day 5 to Day 19 ]
  • Degree of Fluctuation (DF) of BMS-986165 [ Time Frame: Days 1 to 4, Day 5, and Day 19 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03956953 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 17, 2019)
  • Number of participants with Adverse Events (AEs) [ Time Frame: Up to Day 31 ]
  • Number of Participants With Clinically Significant Change in Clinical Laboratory Values [ Time Frame: Up to Day 24 ]
  • Number of Participants With Clinically Significant Change in Vital Signs [ Time Frame: Up to Day 24 ]
  • Number of Participants With Clinically Significant Change in Electrocardiogram (ECG) [ Time Frame: Up to Day 24 ]
  • Number of Participants With Clinically Significant Change in Physical Examination [ Time Frame: Up to Day 24 ]
  • Maximum Observed Plasma Concentration (Cmax) of Metabolites BMT-153261 and BMT-158170 [ Time Frame: Days 1 to 4, Day 5, and Day 19 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • Effective Elimination Half-Life (T-HALFeff) of Metabolites BMT-153261 and BMT-158170 [ Time Frame: Days 1 to 4, Day 5, and Day 19 ]
  • Trough Observed Plasma Concentration (Ctrough) of Metabolites BMT-153261 and BMT-158170 [ Time Frame: Days 1 to 4, Day 5, and Day 19 ]
  • 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 ]
  • Accumulation Index (AI) of Metabolites BMT-153261 and BMT-158170 [ Time Frame: Days 1 to 4, Day 5, and Day 19 ]
  • Degree of Fluctuation (DF) of Metabolites BMT-153261 and BMT-158170 [ Time Frame: Days 1 to 4, Day 5, and Day 19 ]
  • Total Amount of Drug Recovered in Urine (URt) Following Single Oral Doses of BMS-986165 [ Time Frame: Day 1 to Day 5 ]
  • Total Percent of Administered Dose Recovered Unchanged in Urine (%URt) Following Single Oral Doses of BMS-986165 [ Time Frame: Day 1 to Day 5 ]
  • Renal Clearance (CLR) Following Single Oral Doses of BMS-986165 [ Time Frame: Day 1 to Day 5 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Single and Multiple Dose Pharmacokinetics of BMS-986165 in a Randomized, Double-Blind, Placebo-Controlled Study in Healthy Chinese Subjects
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Autoimmune Diseases
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: Group 1: BMS-986165 Dose 1
    Participants will receive Dose 1 on Day 1, and from Day 5 - 19.
    Intervention: Drug: BMS-986165
  • Experimental: Group 2: BMS-986165 Dose 2
    Participants will receive Dose 2 on Day 1, and from Day 5 - 19.
    Intervention: Drug: BMS-986165
  • Placebo Comparator: Group 1: Placebo Dose 1
    Participants will receive placebo matching Dose 1 on Day 1, and from Day 5 - 19.
    Intervention: Other: Placebo
  • Placebo Comparator: Group 2: Placebo Dose 2
    Participants will receive placebo matching Dose 2 on Day 1, and from Day 5 - 19.
    Intervention: Other: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 25, 2019)
135
Original Estimated Enrollment  ICMJE
 (submitted: May 17, 2019)
40
Actual Study Completion Date  ICMJE September 25, 2019
Actual Primary Completion Date September 25, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03956953
Other Study ID Numbers  ICMJE IM011-053
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bristol-Myers Squibb
Study Sponsor  ICMJE Bristol-Myers Squibb
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Bristol-Myers Squibb
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP