A Study to Evaluate the Drug-drug Interaction Potential of BMS-986196 in Healthy Participants

September 25, 2023 updated by: Bristol-Myers Squibb

A Phase 1, Single-center, Open-label, Sequential Study to Evaluate the Drug-drug Interaction Potential of BMS-986196 in Healthy Participants

This study is designed to assess the effect of BMS-986196 on the drug levels of caffeine, montelukast, flurbiprofen, omeprazole, midazolam, digoxin, and pravastatin in healthy participants.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

18

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
    • Utah
      • Millcreek, Utah, United States, 84124
        • ICON plc

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

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Healthy male and female participants as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations.
  • Body mass index of 18.0 to 33.0 kilogram per meter squared (kg/m^2), inclusive, and body weight ≥50.0 kg.

Exclusion Criteria:

  • History of rhabdomyolysis.
  • History of peptic ulcer disease or significant GI bleeding.
  • History of malignancy in the 5 years prior to screening (except fully excised basal cell carcinoma).

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: N/A
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: BMS-986196 and/or Cocktail Probe Substrate Drugs
Drug: BMS-986196
Specified dose on specified days
Drug: Digoxin
Specified dose on specified days
Drug: Caffeine
Specified dose on specified days
Drug: Montelukast
Specified dose on specified days
Drug: Flurbiprofen
Specified dose on specified days
Drug: Omeprazole
Specified dose on specified days
Drug: Midazolam
Specified dose on specified days
Drug: Pravastatin
Specified dose on specified days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Maximum observed plasma concentration (Cmax)
Time Frame: Up to 26 days
Up to 26 days
Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC[INF])
Time Frame: Up to 26 days
Up to 26 days
Area under the plasma concentration-time curve from time zero to time of the last quantifiable concentration (AUC[0-T])
Time Frame: Up to 26 days
Up to 26 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of participants with adverse events (AEs)
Time Frame: Up to 52 days
Up to 52 days
Number of participants with vital sign abnormalities
Time Frame: Up to 28 days
Up to 28 days
Number of participants with physical examination abnormalities
Time Frame: Up to 28 days
Up to 28 days
Time of maximum observed serum concentration (Tmax)
Time Frame: Up to 26 days
Up to 26 days
Apparent terminal phase half-life (T-Half)
Time Frame: Up to 26 days
Up to 26 days
Apparent total body clearance (CLT/F)
Time Frame: Up to 26 days
Up to 26 days
Number of participants with electrocardiogram (ECG) abnormalities
Time Frame: Up to 21 days
Up to 21 days
Number of participants with clinical laboratory abnormalities
Time Frame: Up to 28 days
Up to 28 days
Intensity of Suicidal Ideation as assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS) Score
Time Frame: Up to 28 days
Up to 28 days

Collaborators and Investigators

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

Sponsor

Bristol-Myers Squibb

Investigators

  • Study Director: Bristol-Myers Squibb, 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)

May 31, 2023

Primary Completion (Actual)

August 24, 2023

Study Completion (Actual)

August 24, 2023

Study Registration Dates

First Submitted

May 1, 2023

First Submitted That Met QC Criteria

May 1, 2023

First Posted (Actual)

May 10, 2023

Study Record Updates

Last Update Posted (Actual)

September 26, 2023

Last Update Submitted That Met QC Criteria

September 25, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IM038-022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myers Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosurecommitment.html

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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