A Study of Experimental Medication BMS-986235 in Healthy Subjects

March 16, 2022 updated by: Bristol-Myers Squibb

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

122

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Anaheim, California, United States, 92801
        • Anaheim Clinical Trials
    • Utah
      • Salt Lake City, Utah, United States, 84107
        • PRA Health Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Single ascending dose (SAD): BMS-986235 or Placebo
BMS-986235 or Placebo oral dose
Other: Placebo
Specified dose on specified days
Drug: BMS-986235
Specified dose on specified days
EXPERIMENTAL: Multiple ascending dose (MAD): BMS-986235 or Placebo
BMS-986235 or Placebo oral dose
Other: Placebo
Specified dose on specified days
Drug: BMS-986235
Specified dose on specified days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of serious adverse events (SAE)
Time Frame: Approximately 30 days
Approximately 30 days
Number of deaths
Time Frame: Approximately 30 days
Approximately 30 days
Number of adverse events (AE) leading to study discontinuation
Time Frame: Approximately 30 days
Approximately 30 days
Number of patients with clinically significant changes in ECG parameters, as defined by the investigator
Time Frame: Approximately 30 days
Approximately 30 days
Number of patients with potentially clinically significant changes in vital signs
Time Frame: Approximately 30 days
Approximately 30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 15, 2017

Primary Completion (ACTUAL)

July 2, 2021

Study Completion (ACTUAL)

July 2, 2021

Study Registration Dates

First Submitted

November 6, 2017

First Submitted That Met QC Criteria

November 6, 2017

First Posted (ACTUAL)

November 7, 2017

Study Record Updates

Last Update Posted (ACTUAL)

March 31, 2022

Last Update Submitted That Met QC Criteria

March 16, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CV018-001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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