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

Sponsor
Bristol-Myers Squibb (Industry)
Overall Status
Completed
CT.gov ID
NCT03956953
Collaborator
(none)
135
Enrollment
1
Location
4
Arms
5.7
Actual Duration (Months)
23.6
Patients Per Site Per Month

Study Details

Study Description

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
Phase 1

Study Design

Study Type:
Interventional
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.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 :
Apr 4, 2019
Actual Primary Completion Date :
Sep 25, 2019
Actual Study Completion Date :
Sep 25, 2019

Arms and Interventions

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

Primary Outcome Measures

  1. Maximum Observed Plasma Concentration (Cmax) of BMS-986165 [Days 1 to 4, Day 5, and Day 19]

  2. Time to Maximum Observed Plasma Concentration (Tmax) of BMS-986165 [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 [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 [Day 1 to Day 4]

  5. Apparent Plasma Elimination Half-Life (T-HALF) of BMS-986165 [Days 1 to 4, Day 5, and Day 19]

  6. Apparent Oral Total Body Clearance (CLT/F) of BMS-986165 [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]) [Day 1 to Day 4]

  8. 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]

  9. Apparent Volume of Distribution (Vz/F) of BMS-986165 [Days 1 to 4, Day 5, and Day 19]

  10. Time to Maximum Observed Plasma Concentration (Tmax) of BMS-986165 [Day 5 to Day 19]

  11. Area Under the Plasma Concentration-Time Curve in a Dosing Interval (AUC(TAU)) of BMS-986165 [Day 5 and Day 19]

  12. Effective Elimination Half-Life (T-HALFeff) of BMS-986165 [Days 1 to 4, Day 5, and Day 19]

  13. Trough Observed Plasma Concentration (Ctrough) of BMS-986165 [Day 2 to 20]

  14. Average Plasma Concentration at Steady State (Css-avg) of BMS-986165 [Days 1 to 4, Day 5, and Day 19]

  15. Accumulation Index (AI) of BMS-986165 [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]) [Day 5 to Day 19]

  17. Degree of Fluctuation (DF) of BMS-986165 [Days 1 to 4, Day 5, and Day 19]

Secondary Outcome Measures

  1. Number of participants with Adverse Events (AEs) [Up to Day 31]

  2. Number of Participants With Clinically Significant Change in Clinical Laboratory Values [Up to Day 24]

  3. Number of Participants With Clinically Significant Change in Vital Signs [Up to Day 24]

  4. Number of Participants With Clinically Significant Change in Electrocardiogram (ECG) [Up to Day 24]

  5. Number of Participants With Clinically Significant Change in Physical Examination [Up to Day 24]

  6. Maximum Observed Plasma Concentration (Cmax) of Metabolites BMT-153261 and BMT-158170 [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 [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 [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 [Days 1 to 4, Day 5, and Day 19]

  10. Apparent Plasma Elimination Half-Life (T-HALF) of Metabolites BMT-153261 and BMT-158170 [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 [Days 1 to 4, Day 5, and Day 19]

  12. Effective Elimination Half-Life (T-HALFeff) of Metabolites BMT-153261 and BMT-158170 [Days 1 to 4, Day 5, and Day 19]

  13. Trough Observed Plasma Concentration (Ctrough) of Metabolites BMT-153261 and BMT-158170 [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 [Days 1 to 4, Day 5, and Day 19]

  15. Accumulation Index (AI) of Metabolites BMT-153261 and BMT-158170 [Days 1 to 4, Day 5, and Day 19]

  16. Degree of Fluctuation (DF) of Metabolites BMT-153261 and BMT-158170 [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 [Day 1 to Day 5]

  18. Total Percent of Administered Dose Recovered Unchanged in Urine (%URt) Following Single Oral Doses of BMS-986165 [Day 1 to Day 5]

  19. Renal Clearance (CLR) Following Single Oral Doses of BMS-986165 [Day 1 to Day 5]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 45 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Locations

Site City State Country Postal Code
1 Local Institution Beijing Beijing China 100029

Sponsors and Collaborators

  • Bristol-Myers Squibb

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT03956953
Other Study ID Numbers:
  • IM011-053
First Posted:
May 21, 2019
Last Update Posted:
Jun 18, 2020
Last Verified:
Jun 1, 2020
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:
Autoimmune Diseases
BMS-986165

Study Results

No Results Posted as of Jun 18, 2020