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Clinical Trials/NCT04008992
NCT04008992CompletedPhase 1

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.

Bristol-Myers Squibb2 sites in 2 countries132 target enrollmentStarted: June 18, 2019Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 1
Status
Completed
Sponsor
Enrollment
132
Locations
2
Primary Endpoint
Incidence of Adverse Events (AEs)
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Sequential
Primary Purpose
Prevention
Masking
Double (Participant, Investigator)

Eligibility Criteria

Ages
18 Years to 55 Years (Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •Healthy participants with a body mass Index (BMI) of 18.0 kg/m^2 - 30.0 kg/m^
  • •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

Arms & Interventions

Part A SAD- A3 Cohort

Experimental

Single Ascending dose

Intervention: Iohexol (Diagnostic Test)

Part B MAD - B3 Cohort

Experimental

Multiple Ascending Dose

Intervention: Iohexol (Diagnostic Test)

Part A SAD - A1 Cohort

Experimental

Single Ascending Dose

Intervention: BMS-986259 (Drug)

Part A SAD - A1 Cohort

Experimental

Single Ascending Dose

Intervention: Placebo (Other)

Part A SAD - A1 Cohort

Experimental

Single Ascending Dose

Intervention: P-Aminohippurate (Diagnostic Test)

Part A SAD - A1 Cohort

Experimental

Single Ascending Dose

Intervention: Iohexol (Diagnostic Test)

Part A SAD - A2 Cohort

Experimental

Single Ascending dose

Intervention: BMS-986259 (Drug)

Part A SAD - A2 Cohort

Experimental

Single Ascending dose

Intervention: Placebo (Other)

Part A SAD - A2 Cohort

Experimental

Single Ascending dose

Intervention: P-Aminohippurate (Diagnostic Test)

Part A SAD - A2 Cohort

Experimental

Single Ascending dose

Intervention: Iohexol (Diagnostic Test)

Part A SAD- A3 Cohort

Experimental

Single Ascending dose

Intervention: BMS-986259 (Drug)

Part A SAD- A3 Cohort

Experimental

Single Ascending dose

Intervention: Placebo (Other)

Part A SAD- A3 Cohort

Experimental

Single Ascending dose

Intervention: P-Aminohippurate (Diagnostic Test)

Part A SAD- A4 Cohort

Experimental

Single Ascending dose

Intervention: BMS-986259 (Drug)

Part A SAD- A4 Cohort

Experimental

Single Ascending dose

Intervention: Placebo (Other)

Part A SAD- A4 Cohort

Experimental

Single Ascending dose

Intervention: P-Aminohippurate (Diagnostic Test)

Part A SAD- A4 Cohort

Experimental

Single Ascending dose

Intervention: Iohexol (Diagnostic Test)

Part A SAD - A5 Cohort

Experimental

Single Ascending dose

Intervention: BMS-986259 (Drug)

Part A SAD - A5 Cohort

Experimental

Single Ascending dose

Intervention: Placebo (Other)

Part A SAD - A5 Cohort

Experimental

Single Ascending dose

Intervention: P-Aminohippurate (Diagnostic Test)

Part A SAD - A5 Cohort

Experimental

Single Ascending dose

Intervention: Iohexol (Diagnostic Test)

Part A SAD- A6 Cohort

Experimental

Single Ascending dose

Intervention: BMS-986259 (Drug)

Part A SAD- A6 Cohort

Experimental

Single Ascending dose

Intervention: Placebo (Other)

Part A SAD- A6 Cohort

Experimental

Single Ascending dose

Intervention: P-Aminohippurate (Diagnostic Test)

Part A SAD- A6 Cohort

Experimental

Single Ascending dose

Intervention: Iohexol (Diagnostic Test)

Part B MAD- B1 Cohort

Experimental

Multiple Ascending Dose

Intervention: BMS-986259 (Drug)

Part B MAD- B1 Cohort

Experimental

Multiple Ascending Dose

Intervention: Placebo (Other)

Part B MAD- B1 Cohort

Experimental

Multiple Ascending Dose

Intervention: P-Aminohippurate (Diagnostic Test)

Part B MAD- B1 Cohort

Experimental

Multiple Ascending Dose

Intervention: Iohexol (Diagnostic Test)

Part B MAD - B2 Cohort

Experimental

Multiple Ascending Dose

Intervention: BMS-986259 (Drug)

Part B MAD - B2 Cohort

Experimental

Multiple Ascending Dose

Intervention: Placebo (Other)

Part B MAD - B2 Cohort

Experimental

Multiple Ascending Dose

Intervention: P-Aminohippurate (Diagnostic Test)

Part B MAD - B2 Cohort

Experimental

Multiple Ascending Dose

Intervention: Iohexol (Diagnostic Test)

Part B MAD - B3 Cohort

Experimental

Multiple Ascending Dose

Intervention: BMS-986259 (Drug)

Part B MAD - B3 Cohort

Experimental

Multiple Ascending Dose

Intervention: Placebo (Other)

Part B MAD - B3 Cohort

Experimental

Multiple Ascending Dose

Intervention: P-Aminohippurate (Diagnostic Test)

Part B MAD - B4 Cohort

Experimental

Multiple Ascending Dose

Intervention: BMS-986259 (Drug)

Part B MAD - B4 Cohort

Experimental

Multiple Ascending Dose

Intervention: Placebo (Other)

Part B MAD - B4 Cohort

Experimental

Multiple Ascending Dose

Intervention: P-Aminohippurate (Diagnostic Test)

Part B MAD - B4 Cohort

Experimental

Multiple Ascending Dose

Intervention: Iohexol (Diagnostic Test)

Part C JMAD - C1 Cohort

Experimental

Japanese Multiple Ascending Dose

Intervention: BMS-986259 (Drug)

Part C JMAD - C1 Cohort

Experimental

Japanese Multiple Ascending Dose

Intervention: Placebo (Other)

Part C JMAD - C1 Cohort

Experimental

Japanese Multiple Ascending Dose

Intervention: P-Aminohippurate (Diagnostic Test)

Part C JMAD - C1 Cohort

Experimental

Japanese Multiple Ascending Dose

Intervention: Iohexol (Diagnostic Test)

Part C JMAD - C2 Cohort

Experimental

Japanese Multiple Ascending Dose

Intervention: BMS-986259 (Drug)

Part C JMAD - C2 Cohort

Experimental

Japanese Multiple Ascending Dose

Intervention: Placebo (Other)

Part C JMAD - C2 Cohort

Experimental

Japanese Multiple Ascending Dose

Intervention: P-Aminohippurate (Diagnostic Test)

Part C JMAD - C2 Cohort

Experimental

Japanese Multiple Ascending Dose

Intervention: Iohexol (Diagnostic Test)

Part C JMAD - C3 Cohort

Experimental

Japanese Multiple Ascending Dose

Intervention: BMS-986259 (Drug)

Part C JMAD - C3 Cohort

Experimental

Japanese Multiple Ascending Dose

Intervention: Placebo (Other)

Part C JMAD - C3 Cohort

Experimental

Japanese Multiple Ascending Dose

Intervention: P-Aminohippurate (Diagnostic Test)

Part C JMAD - C3 Cohort

Experimental

Japanese Multiple Ascending Dose

Intervention: Iohexol (Diagnostic Test)

Outcomes

Primary Outcomes

Incidence of Adverse Events (AEs)

Time Frame: Up to 7 weeks

Number of clinically significant changes in vital signs

Time Frame: Up to 7 weeks

Number of clinically significant changes in physical examinations

Time Frame: Up to 7 weeks

AEs leading to discontinuation

Time Frame: Up to 7 weeks

Incidence of Serious Adverse Events (SAEs)

Time Frame: up to 7 weeks

Number of clinically significant changes in ECG (electrocardiogram)

Time Frame: Up to 7 weeks

Number of clinically significant changes in clinical laboratory tests

Time Frame: Up to 7 weeks

Secondary Outcomes

  • Half life (T-HALF)- Part B and Part C MAD(Up to 7 weeks)
  • Maximum observed concentration(Cmax)-Part B and Part C MAD(Up to 7 years)
  • Half life (T-HALF)- Part A SAD(Up to 7 weeks)
  • Apparent total body clearance(CL/F)-Part A SAD(Up to 7 weeks)
  • 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(Up to 7 weeks)
  • Apparent volume of distribution at terminal phase(Vz/F)- Part B and Part C MAD(Up to 7 weeks)
  • Terminal elimination rate constant (Lz)-Part A SAD(up to 7 weeks)
  • Area under the concentration-time curve from time zero to the time of the last quantifiable concentration(AUC(0-T)- Part A SAD(Up to 7 weeks)
  • Area under the concentration-time curve in one dosing interval(AUC(TAU)- Part B and Part C MAD(Up to 7 weeks)
  • Terminal elimination rate constant (Lz)-Part B and Part C MAD(up to 7 weeks)
  • Accumulation Ratio Cmax (AR(Cmax)-Part B and Part C MAD(Up to 7 weeks)
  • Maximum observed concentration(Cmax)- Part A SAD(up to 7 weeks)
  • Time of maximum observed concentration(Tmax)- Part A SAD(Up to 7 weeks)
  • Area under the concentration-time curve from time zero extrapolated to infinite time(AUC(INF)-Part A SAD(Up to 7 weeks)
  • Apparent volume of distribution at terminal phase(Vz/F)- Part A SAD(Up to 7 weeks)
  • Time of maximum observed concentration(Tmax)-Part B and Part C MAD(Up tp 7 weeks)
  • Apparent total body clearance(CL/F)-Part B and Part C MAD(Up to 7 weeks)
  • Accumulation Ratio AUC(TAU) (AR(AUC[TAU])- Part B and Part C MAD(Up to 7 weeks)

Investigators

Sponsor
Bristol-Myers Squibb
Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (2)

Loading locations...

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