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

NCT ID: NCT04008992

Last Updated: 2021-04-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

132 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-18

Study Completion Date

2021-01-04

Brief Summary

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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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Detailed Description

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Conditions

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Healthy Participants

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Part A SAD - A1 Cohort

Single Ascending Dose

Group Type EXPERIMENTAL

BMS-986259

Intervention Type DRUG

Single and Multiple ascending dose from Dose 1 to Dose 5

Placebo

Intervention Type OTHER

Placebo matching BMS-986259

P-Aminohippurate

Intervention Type DIAGNOSTIC_TEST

Diagnostic Agent

Iohexol

Intervention Type DIAGNOSTIC_TEST

Diagnostic Agent

Part A SAD - A2 Cohort

Single Ascending dose

Group Type EXPERIMENTAL

BMS-986259

Intervention Type DRUG

Single and Multiple ascending dose from Dose 1 to Dose 5

Placebo

Intervention Type OTHER

Placebo matching BMS-986259

P-Aminohippurate

Intervention Type DIAGNOSTIC_TEST

Diagnostic Agent

Iohexol

Intervention Type DIAGNOSTIC_TEST

Diagnostic Agent

Part A SAD- A3 Cohort

Single Ascending dose

Group Type EXPERIMENTAL

BMS-986259

Intervention Type DRUG

Single and Multiple ascending dose from Dose 1 to Dose 5

Placebo

Intervention Type OTHER

Placebo matching BMS-986259

P-Aminohippurate

Intervention Type DIAGNOSTIC_TEST

Diagnostic Agent

Iohexol

Intervention Type DIAGNOSTIC_TEST

Diagnostic Agent

Part A SAD- A4 Cohort

Single Ascending dose

Group Type EXPERIMENTAL

BMS-986259

Intervention Type DRUG

Single and Multiple ascending dose from Dose 1 to Dose 5

Placebo

Intervention Type OTHER

Placebo matching BMS-986259

P-Aminohippurate

Intervention Type DIAGNOSTIC_TEST

Diagnostic Agent

Iohexol

Intervention Type DIAGNOSTIC_TEST

Diagnostic Agent

Part A SAD - A5 Cohort

Single Ascending dose

Group Type EXPERIMENTAL

BMS-986259

Intervention Type DRUG

Single and Multiple ascending dose from Dose 1 to Dose 5

Placebo

Intervention Type OTHER

Placebo matching BMS-986259

P-Aminohippurate

Intervention Type DIAGNOSTIC_TEST

Diagnostic Agent

Iohexol

Intervention Type DIAGNOSTIC_TEST

Diagnostic Agent

Part A SAD- A6 Cohort

Single Ascending dose

Group Type EXPERIMENTAL

BMS-986259

Intervention Type DRUG

Single and Multiple ascending dose from Dose 1 to Dose 5

Placebo

Intervention Type OTHER

Placebo matching BMS-986259

P-Aminohippurate

Intervention Type DIAGNOSTIC_TEST

Diagnostic Agent

Iohexol

Intervention Type DIAGNOSTIC_TEST

Diagnostic Agent

Part B MAD- B1 Cohort

Multiple Ascending Dose

Group Type EXPERIMENTAL

BMS-986259

Intervention Type DRUG

Single and Multiple ascending dose from Dose 1 to Dose 5

Placebo

Intervention Type OTHER

Placebo matching BMS-986259

P-Aminohippurate

Intervention Type DIAGNOSTIC_TEST

Diagnostic Agent

Iohexol

Intervention Type DIAGNOSTIC_TEST

Diagnostic Agent

Part B MAD - B2 Cohort

Multiple Ascending Dose

Group Type EXPERIMENTAL

BMS-986259

Intervention Type DRUG

Single and Multiple ascending dose from Dose 1 to Dose 5

Placebo

Intervention Type OTHER

Placebo matching BMS-986259

P-Aminohippurate

Intervention Type DIAGNOSTIC_TEST

Diagnostic Agent

Iohexol

Intervention Type DIAGNOSTIC_TEST

Diagnostic Agent

Part B MAD - B3 Cohort

Multiple Ascending Dose

Group Type EXPERIMENTAL

BMS-986259

Intervention Type DRUG

Single and Multiple ascending dose from Dose 1 to Dose 5

Placebo

Intervention Type OTHER

Placebo matching BMS-986259

P-Aminohippurate

Intervention Type DIAGNOSTIC_TEST

Diagnostic Agent

Iohexol

Intervention Type DIAGNOSTIC_TEST

Diagnostic Agent

Part B MAD - B4 Cohort

Multiple Ascending Dose

Group Type EXPERIMENTAL

BMS-986259

Intervention Type DRUG

Single and Multiple ascending dose from Dose 1 to Dose 5

Placebo

Intervention Type OTHER

Placebo matching BMS-986259

P-Aminohippurate

Intervention Type DIAGNOSTIC_TEST

Diagnostic Agent

Iohexol

Intervention Type DIAGNOSTIC_TEST

Diagnostic Agent

Part C JMAD - C1 Cohort

Japanese Multiple Ascending Dose

Group Type EXPERIMENTAL

BMS-986259

Intervention Type DRUG

Single and Multiple ascending dose from Dose 1 to Dose 5

Placebo

Intervention Type OTHER

Placebo matching BMS-986259

P-Aminohippurate

Intervention Type DIAGNOSTIC_TEST

Diagnostic Agent

Iohexol

Intervention Type DIAGNOSTIC_TEST

Diagnostic Agent

Part C JMAD - C2 Cohort

Japanese Multiple Ascending Dose

Group Type EXPERIMENTAL

BMS-986259

Intervention Type DRUG

Single and Multiple ascending dose from Dose 1 to Dose 5

Placebo

Intervention Type OTHER

Placebo matching BMS-986259

P-Aminohippurate

Intervention Type DIAGNOSTIC_TEST

Diagnostic Agent

Iohexol

Intervention Type DIAGNOSTIC_TEST

Diagnostic Agent

Part C JMAD - C3 Cohort

Japanese Multiple Ascending Dose

Group Type EXPERIMENTAL

BMS-986259

Intervention Type DRUG

Single and Multiple ascending dose from Dose 1 to Dose 5

Placebo

Intervention Type OTHER

Placebo matching BMS-986259

P-Aminohippurate

Intervention Type DIAGNOSTIC_TEST

Diagnostic Agent

Iohexol

Intervention Type DIAGNOSTIC_TEST

Diagnostic Agent

Interventions

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BMS-986259

Single and Multiple ascending dose from Dose 1 to Dose 5

Intervention Type DRUG

Placebo

Placebo matching BMS-986259

Intervention Type OTHER

P-Aminohippurate

Diagnostic Agent

Intervention Type DIAGNOSTIC_TEST

Iohexol

Diagnostic Agent

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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PRA Health Sciences - Groningen

Groningen, , Netherlands

Site Status

Richmond Pharmacology

London, , United Kingdom

Site Status

Countries

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Netherlands United Kingdom

Related Links

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https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html

BMS Clinical Trial Information

https://www.bmsstudyconnect.com/s/US/English/USenHome

BMS Clinical Trial Patient Recruiting

https://www.bms.com/researchers-and-partners/investigator-inquiry-form.html

Investigator Inquiry Form

https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm

FDA Safety Alerts and Recalls

Other Identifiers

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CV019-002

Identifier Type: -

Identifier Source: org_study_id

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