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An Ascending Dose Study of BMS-986259 to Study Safety in Healthy Participants

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ClinicalTrials.gov Identifier: NCT04008992
Recruitment Status : Active, not recruiting
First Posted : July 5, 2019
Last Update Posted : April 9, 2020
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Study Description
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Brief Summary:
A Randomized double blind, placebo controlled study of BMS-986259 to evaluate the safety and effectiveness of the drug amongst different conditions and populations.

Condition or disease Intervention/treatment Phase
Healthy Participants Drug: BMS-986259 Other: Placebo Diagnostic Test: P-Aminohippurate Diagnostic Test: Iohexol Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 78 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: A Randomized, Double-Blinded, Placebo-Controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of BMS-986259 in Healthy Participants.
Actual Study Start Date : June 17, 2019
Estimated Primary Completion Date : August 22, 2020
Estimated Study Completion Date : August 22, 2020
Arms and Interventions
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Arm Intervention/treatment
Experimental: Part A SAD - A1 Cohort
Single Ascending Dose
 Drug: BMS-986259
Single and Multiple ascending dose from Dose 1 to Dose 5

Other: Placebo
Placebo matching BMS-986259

Diagnostic Test: P-Aminohippurate
Diagnostic Agent

Diagnostic Test: Iohexol
Diagnostic Agent
Experimental: Part A SAD - A2 Cohort
Single Ascending dose
 Drug: BMS-986259
Single and Multiple ascending dose from Dose 1 to Dose 5

Other: Placebo
Placebo matching BMS-986259

Diagnostic Test: P-Aminohippurate
Diagnostic Agent

Diagnostic Test: Iohexol
Diagnostic Agent
Experimental: Part A SAD- A3 Cohort
Single Ascending dose
 Drug: BMS-986259
Single and Multiple ascending dose from Dose 1 to Dose 5

Other: Placebo
Placebo matching BMS-986259

Diagnostic Test: P-Aminohippurate
Diagnostic Agent

Diagnostic Test: Iohexol
Diagnostic Agent
Experimental: Part A SAD- A4 Cohort
Single Ascending dose
 Drug: BMS-986259
Single and Multiple ascending dose from Dose 1 to Dose 5

Other: Placebo
Placebo matching BMS-986259

Diagnostic Test: P-Aminohippurate
Diagnostic Agent

Diagnostic Test: Iohexol
Diagnostic Agent
Experimental: Part A SAD - A5 Cohort
Single Ascending dose
 Drug: BMS-986259
Single and Multiple ascending dose from Dose 1 to Dose 5

Other: Placebo
Placebo matching BMS-986259

Diagnostic Test: P-Aminohippurate
Diagnostic Agent

Diagnostic Test: Iohexol
Diagnostic Agent
Experimental: Part A SAD- A6 Cohort
Single Ascending dose
 Drug: BMS-986259
Single and Multiple ascending dose from Dose 1 to Dose 5

Other: Placebo
Placebo matching BMS-986259

Diagnostic Test: P-Aminohippurate
Diagnostic Agent

Diagnostic Test: Iohexol
Diagnostic Agent
Experimental: Part B MAD- B1 Cohort
Multiple Ascending Dose
 Drug: BMS-986259
Single and Multiple ascending dose from Dose 1 to Dose 5

Other: Placebo
Placebo matching BMS-986259

Diagnostic Test: P-Aminohippurate
Diagnostic Agent

Diagnostic Test: Iohexol
Diagnostic Agent
Experimental: Part B MAD - B2 Cohort
Multiple Ascending Dose
 Drug: BMS-986259
Single and Multiple ascending dose from Dose 1 to Dose 5

Other: Placebo
Placebo matching BMS-986259

Diagnostic Test: P-Aminohippurate
Diagnostic Agent

Diagnostic Test: Iohexol
Diagnostic Agent
Experimental: Part B MAD - B3 Cohort
Multiple Ascending Dose
 Drug: BMS-986259
Single and Multiple ascending dose from Dose 1 to Dose 5

Other: Placebo
Placebo matching BMS-986259

Diagnostic Test: P-Aminohippurate
Diagnostic Agent

Diagnostic Test: Iohexol
Diagnostic Agent
Experimental: Part B MAD - B4 Cohort
Multiple Ascending Dose
 Drug: BMS-986259
Single and Multiple ascending dose from Dose 1 to Dose 5

Other: Placebo
Placebo matching BMS-986259

Diagnostic Test: P-Aminohippurate
Diagnostic Agent

Diagnostic Test: Iohexol
Diagnostic Agent
Experimental: Part C JMAD - C1 Cohort
Japanese Multiple Ascending Dose
 Drug: BMS-986259
Single and Multiple ascending dose from Dose 1 to Dose 5

Other: Placebo
Placebo matching BMS-986259

Diagnostic Test: P-Aminohippurate
Diagnostic Agent

Diagnostic Test: Iohexol
Diagnostic Agent
Experimental: Part C JMAD - C2 Cohort
Japanese Multiple Ascending Dose
 Drug: BMS-986259
Single and Multiple ascending dose from Dose 1 to Dose 5

Other: Placebo
Placebo matching BMS-986259

Diagnostic Test: P-Aminohippurate
Diagnostic Agent

Diagnostic Test: Iohexol
Diagnostic Agent
Experimental: Part C JMAD - C3 Cohort
Japanese Multiple Ascending Dose
 Drug: BMS-986259
Single and Multiple ascending dose from Dose 1 to Dose 5

Other: Placebo
Placebo matching BMS-986259

Diagnostic Test: P-Aminohippurate
Diagnostic Agent

Diagnostic Test: Iohexol
Diagnostic Agent


Outcome Measures
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Primary Outcome Measures :
  1. Incidence of Adverse Events (AEs) [ Time Frame: Up to 7 weeks ]
  2. Incidence of Serious Adverse Events (SAEs) [ Time Frame: up to 7 weeks ]
  3. AEs leading to discontinuation [ Time Frame: Up to 7 weeks ]
  4. Number of clinically significant changes in vital signs [ Time Frame: Up to 7 weeks ]
  5. Number of clinically significant changes in ECG (electrocardiogram) [ Time Frame: Up to 7 weeks ]
  6. Number of clinically significant changes in physical examinations [ Time Frame: Up to 7 weeks ]
  7. Number of clinically significant changes in clinical laboratory tests [ Time Frame: Up to 7 weeks ]

Secondary Outcome Measures :
  1. Maximum observed concentration(Cmax)- Part A SAD [ Time Frame: up to 7 weeks ]
  2. Time of maximum observed concentration(Tmax)- Part A SAD [ Time Frame: Up to 7 weeks ]
  3. Terminal elimination rate constant (Lz)-Part A SAD [ Time Frame: up to 7 weeks ]
  4. Half life (T-HALF)- Part A SAD [ Time Frame: Up to 7 weeks ]
  5. Area under the concentration-time curve from time zero to the time of the last quantifiable concentration(AUC(0-T)- Part A SAD [ Time Frame: Up to 7 weeks ]
  6. Area under the concentration-time curve from time zero extrapolated to infinite time(AUC(INF)-Part A SAD [ Time Frame: Up to 7 weeks ]
  7. Apparent total body clearance(CL/F)-Part A SAD [ Time Frame: Up to 7 weeks ]
  8. Apparent volume of distribution at terminal phase(Vz/F)- Part A SAD [ Time Frame: Up to 7 weeks ]
  9. Maximum observed concentration(Cmax)-Part B and Part C MAD [ Time Frame: Up to 7 years ]
    For day 1 , day 13 and day 14

  10. Time of maximum observed concentration(Tmax)-Part B and Part C MAD [ Time Frame: Up tp 7 weeks ]
    For day 1, day 13 and day 14

  11. Area under the concentration-time curve in one dosing interval(AUC(TAU)- Part B and Part C MAD [ Time Frame: Up to 7 weeks ]
    For day 1 and day 14

  12. Area under the concentration-time curve from time zero to the time of the last quantifiable concentration(AUC(0-T)-Part B and Part C MAD [ Time Frame: Up to 7 weeks ]
    For Day 14

  13. Terminal elimination rate constant (Lz)-Part B and Part C MAD [ Time Frame: up to 7 weeks ]
    For day 14

  14. Half life (T-HALF)- Part B and Part C MAD [ Time Frame: Up to 7 weeks ]
    For day 14

  15. Apparent total body clearance(CL/F)-Part B and Part C MAD [ Time Frame: Up to 7 weeks ]
    For day 14

  16. Apparent volume of distribution at terminal phase(Vz/F)- Part B and Part C MAD [ Time Frame: Up to 7 weeks ]
    For day 14

  17. Accumulation Ratio Cmax (AR(Cmax)-Part B and Part C MAD [ Time Frame: Up to 7 weeks ]
    For day 14

  18. Accumulation Ratio AUC(TAU) (AR(AUC[TAU])- Part B and Part C MAD [ Time Frame: Up to 7 weeks ]
    for day 14


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy participants with a body mass Index (BMI) of 18.0 kg/m^2 - 30.0 kg/m^2.
  • Males and females not of child bearing potential.
  • Participants in the Japanese Cohorts in Part C must be first-generation Japanese (born in Japan, not living outside of Japan for more than 10 years, and both parents are ethnically Japanese.)

Exclusion Criteria:

  • Any previous dosing in another cohort in the current study or participation in an investigational drug within 2 months prior to (the first) drug administration in the current study.
  • Any Significant Acute or Chronic medical Illness, major surgery in 12 months, or so smoking or used smoking cessation in 3 months.
  • Inability to be venipunctured and/or tolerate venous access. ,abnormalities in hemoglobin or positive screen for hepatitis C, Hepatitis B, Human Immunodeficiency Virus (HIV), including hepatic disease
Contacts and Locations
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT04008992


Locations
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Netherlands
PRA Health Sciences - Groningen
Groningen, Netherlands, 9728 NZ
United Kingdom
Richmond Pharmacology
London, United Kingdom, SE1 1YR
Sponsors and Collaborators
Bristol-Myers Squibb
More Information
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Additional Information:

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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT04008992    
Other Study ID Numbers: CV019-002
First Posted: July 5, 2019    Key Record Dates
Last Update Posted: April 9, 2020
Last Verified: April 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No