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

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.

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 Overview

• Status: Completed
• Conditions: Healthy Participants
• Intervention / Treatment: Drug: BMS-986259; Other: Placebo; Diagnostic test: P-Aminohippurate; Diagnostic test: Iohexol

• Study Type: Interventional
• Enrollment (Actual): 132
• Phase: Phase 1

Contacts and Locations

Study Locations

• Netherlands
  • Groningen, Netherlands, 9728 NZ
    • PRA Health Sciences - Groningen
• United Kingdom
  • London, United Kingdom, SE1 1YR
    • Richmond Pharmacology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Double

Number of Arms

13

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence of Adverse Events (AEs)	Up to 7 weeks
Incidence of Serious Adverse Events (SAEs)	up to 7 weeks
AEs leading to discontinuation	Up to 7 weeks
Number of clinically significant changes in vital signs	Up to 7 weeks
Number of clinically significant changes in ECG (electrocardiogram)	Up to 7 weeks
Number of clinically significant changes in physical examinations	Up to 7 weeks
Number of clinically significant changes in clinical laboratory tests	Up to 7 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum observed concentration(Cmax)- Part A SAD		up to 7 weeks
Time of maximum observed concentration(Tmax)- Part A SAD		Up to 7 weeks
Terminal elimination rate constant (Lz)-Part A SAD		up to 7 weeks
Half life (T-HALF)- 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 from time zero extrapolated to infinite time(AUC(INF)-Part A SAD		Up to 7 weeks
Apparent total body clearance(CL/F)-Part A SAD		Up to 7 weeks
Apparent volume of distribution at terminal phase(Vz/F)- Part A SAD		Up to 7 weeks
Maximum observed concentration(Cmax)-Part B and Part C MAD	For day 1 , day 13 and day 14	Up to 7 years
Time of maximum observed concentration(Tmax)-Part B and Part C MAD	For day 1, day 13 and day 14	Up tp 7 weeks
Area under the concentration-time curve in one dosing interval(AUC(TAU)- Part B and Part C MAD	For day 1 and day 14	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	For Day 14	Up to 7 weeks
Terminal elimination rate constant (Lz)-Part B and Part C MAD	For day 14	up to 7 weeks
Half life (T-HALF)- Part B and Part C MAD	For day 14	Up to 7 weeks
Apparent total body clearance(CL/F)-Part B and Part C MAD	For day 14	Up to 7 weeks
Apparent volume of distribution at terminal phase(Vz/F)- Part B and Part C MAD	For day 14	Up to 7 weeks
Accumulation Ratio Cmax (AR(Cmax)-Part B and Part C MAD	For day 14	Up to 7 weeks
Accumulation Ratio AUC(TAU) (AR(AUC[TAU])- Part B and Part C MAD	for day 14	Up to 7 weeks

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb

Publications and helpful links

Helpful Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting
• FDA Safety Alerts and Recalls

Study record dates

Study Major Dates

• Study Start (Actual): June 18, 2019
• Primary Completion (Actual): January 4, 2021
• Study Completion (Actual): January 4, 2021

Study Registration Dates

• First Submitted: June 20, 2019
• First Submitted That Met QC Criteria: July 2, 2019
• First Posted (Actual): July 5, 2019

Study Record Updates

• Last Update Posted (Actual): April 9, 2021
• Last Update Submitted That Met QC Criteria: April 8, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: CV019-002

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No