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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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Autoimmune Diseases Drug: BMS-986165 Other: Placebo Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 135 participants
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
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
Actual Study Start Date : April 14, 2019
Actual Primary Completion Date : September 25, 2019
Actual Study Completion Date : September 25, 2019

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Group 1: BMS-986165 Dose 1
Participants will receive Dose 1 on Day 1, and from Day 5 - 19.
 Drug: BMS-986165
Dose 1 or Dose 2 on Day 1, and from Days 5-19'
Experimental: Group 2: BMS-986165 Dose 2
Participants will receive Dose 2 on Day 1, and from Day 5 - 19.
 Drug: BMS-986165
Dose 1 or Dose 2 on Day 1, and from Days 5-19'
Placebo Comparator: Group 1: Placebo Dose 1
Participants will receive placebo matching Dose 1 on Day 1, and from Day 5 - 19.
 Other: Placebo
Placebo matching Dose 1 or Dose 2 on Day 1, and from Days 5-19
Placebo Comparator: Group 2: Placebo Dose 2
Participants will receive placebo matching Dose 2 on Day 1, and from Day 5 - 19.
 Other: Placebo
Placebo matching Dose 1 or Dose 2 on Day 1, and from Days 5-19


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03956953


Locations
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China, Beijing
Local Institution
Beijing, Beijing, China, 100029
Sponsors and Collaborators
Bristol-Myers Squibb
More Information
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Additional Information:
BMS Clinical Trial Information  This link exits the ClinicalTrials.gov site BMS Clinical Trial Patient Recruiting  This link exits the ClinicalTrials.gov site Investigator Inquiry Form  This link exits the ClinicalTrials.gov site FDA Safety Alerts and Recalls  This link exits the ClinicalTrials.gov site

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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT03956953     History of Changes
Other Study ID Numbers: IM011-053
First Posted: May 21, 2019    Key Record Dates
Last Update Posted: October 28, 2019
Last Verified: October 2019

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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
Additional relevant MeSH terms:
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Autoimmune Diseases
Immune System Diseases