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Completed

NCT Number: NCT04008992

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

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

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Key information

Conditions

Healthy Participants

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

PRA Health Sciences - Groningen, Groningen, Netherlands

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

BMS-986259

Drug

Single and Multiple ascending dose from Dose 1 to Dose 5

Placebo

Other

Placebo matching BMS-986259

P-Aminohippurate

Diagnostic Test

Diagnostic Agent

Iohexol

Diagnostic Test

Diagnostic Agent

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study 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.

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Jul 5, 2019
Registry last updated
Apr 9, 2021

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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