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A Study of Experimental Medication BMS-986235 in Healthy Subjects

Primary Purpose

Mediators of Inflammation

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

BMS-986235

Placebo

About this trial

This is an interventional treatment trial for Mediators of Inflammation

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Patients must be normal healthy volunteers as determined by no clinically significant deviations in medical history, physical examination, ECGs, vital signs, and clinical laboratory determinations
Patients must have a body mass index (BMI) of 18 - 30 mg/kg2, inclusive

Exclusion Criteria:

Patients that are pregnant
Patient with any significant acute or chronic medical illness
Patient with a current or recent (within 3 months of study treatment administration) gastrointestinal disease that could affect absorption
Patient with any surgery within 12 weeks of study treatment administration
Patient with any gastrointestinal surgery that could impact upon the absorption of study drug
Patient who donated blood to a blood bank or in a clinical study (except a screening visit) within 12 weeks of study drug administration (within 2 weeks for plasma only)
Patient who received a blood transfusion within 12 weeks of study drug administration

Other protocol defined inclusion/exclusion criteria apply

Sites / Locations

Anaheim Clinical Trials
PRA Health Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Single ascending dose (SAD): BMS-986235 or Placebo

Multiple ascending dose (MAD): BMS-986235 or Placebo

Arm Description

BMS-986235 or Placebo oral dose

Outcomes

Primary Outcome Measures

Number of serious adverse events (SAE)

Number of deaths

Number of adverse events (AE) leading to study discontinuation

Number of patients with clinically significant changes in ECG parameters, as defined by the investigator

Number of patients with potentially clinically significant changes in vital signs

Secondary Outcome Measures

Full Information

NCT ID

NCT03335553

First Posted

November 6, 2017

Last Updated

March 16, 2022

Sponsor

Bristol-Myers Squibb

1. Study Identification

Unique Protocol Identification Number

NCT03335553

Brief Title

A Study of Experimental Medication BMS-986235 in Healthy Subjects

Official Title

Randomized, Double-Blind, Placebo-Controlled Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BMS-986235 in Healthy Subjects

Study Type

Interventional

2. Study Status

Record Verification Date

March 2022

Overall Recruitment Status

Completed

Study Start Date

November 15, 2017 (Actual)

Primary Completion Date

July 2, 2021 (Actual)

Study Completion Date

July 2, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Bristol-Myers Squibb

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

This is a study of experimental medication BMS-986235 in healthy subjects.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Mediators of Inflammation

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

122 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Single ascending dose (SAD): BMS-986235 or Placebo

Arm Type

Experimental

Arm Description

BMS-986235 or Placebo oral dose

Arm Title

Multiple ascending dose (MAD): BMS-986235 or Placebo

Arm Type

Experimental

Arm Description

BMS-986235 or Placebo oral dose

Intervention Type

Drug

Intervention Name(s)

BMS-986235

Intervention Description

Specified dose on specified days

Intervention Type

Other

Intervention Name(s)

Placebo

Intervention Description

Specified dose on specified days

Primary Outcome Measure Information:

Title

Number of serious adverse events (SAE)

Time Frame

Approximately 30 days

Title

Number of deaths

Time Frame

Approximately 30 days

Title

Number of adverse events (AE) leading to study discontinuation

Time Frame

Approximately 30 days

Title

Number of patients with clinically significant changes in ECG parameters, as defined by the investigator

Time Frame

Approximately 30 days

Title

Number of patients with potentially clinically significant changes in vital signs

Time Frame

Approximately 30 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients must be normal healthy volunteers as determined by no clinically significant deviations in medical history, physical examination, ECGs, vital signs, and clinical laboratory determinations Patients must have a body mass index (BMI) of 18 - 30 mg/kg2, inclusive Exclusion Criteria: Patients that are pregnant Patient with any significant acute or chronic medical illness Patient with a current or recent (within 3 months of study treatment administration) gastrointestinal disease that could affect absorption Patient with any surgery within 12 weeks of study treatment administration Patient with any gastrointestinal surgery that could impact upon the absorption of study drug Patient who donated blood to a blood bank or in a clinical study (except a screening visit) within 12 weeks of study drug administration (within 2 weeks for plasma only) Patient who received a blood transfusion within 12 weeks of study drug administration Other protocol defined inclusion/exclusion criteria apply

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bristol-Myers Squibb

Organizational Affiliation

Bristol-Myers Squibb

Official's Role

Study Director

Facility Information:

Facility Name

Anaheim Clinical Trials

City

Anaheim

State/Province

California

ZIP/Postal Code

92801

Country

United States

Facility Name

PRA Health Sciences

City

Salt Lake City

State/Province

Utah

ZIP/Postal Code

84107

Country

United States

12. IPD Sharing Statement

Links:

URL

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

Description

BMS Clinical Trial Information

URL

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

Description

BMS Clinical Trial Patient Recruiting

URL

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

Description

Investigator Inquiry Form

URL

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

Description

FDA Safety Alerts and Recalls

Learn more about this trial

A Study of Experimental Medication BMS-986235 in Healthy Subjects

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