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

Bristol-Myers Squibb132 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

132

Conditions

Healthy Participants

Interventions

BMS-986259DRUG

Single and Multiple ascending dose from Dose 1 to Dose 5

PlaceboOTHER

Placebo matching BMS-986259

P-AminohippurateDIAGNOSTIC_TEST

Diagnostic Agent

Iohexol

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (2)

PRA Health Sciences - Groningen

Groningen, Netherlands

Richmond Pharmacology

London, United Kingdom

Outcomes

Primary Outcomes

Incidence of Adverse Events (AEs)

Time frame: Up to 7 weeks

Incidence of Serious Adverse Events (SAEs)

Time frame: up to 7 weeks

AEs leading to discontinuation

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 ECG (electrocardiogram)

Time frame: Up to 7 weeks

Number of clinically significant changes in physical examinations

Time frame: Up to 7 weeks

Number of clinically significant changes in clinical laboratory tests

Time frame: Up to 7 weeks

Secondary Outcomes

Maximum observed concentration(Cmax)- Part A SAD

Time frame: up to 7 weeks

Time of maximum observed concentration(Tmax)- Part A SAD

Time frame: Up to 7 weeks

Terminal elimination rate constant (Lz)-Part A SAD

Time frame: up to 7 weeks

Half life (T-HALF)- Part A SAD

Time frame: 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

Data from ClinicalTrials.gov

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