Study to Characterize the Effects of Cytochrome p450 1A2 Inhibition on Systemic Exposure to BMS-986165

November 9, 2021 updated by: Bristol-Myers Squibb

An Open-label, Single-sequence Study to Investigate the Effects of Cytochrome P450 1A2 Inhibition on the Pharmacokinetics of BMS-986165 in Healthy Participants

To compare the pharmacokinetic characteristics of BMS-986165 after a single-dose administration alone vs. in combination with fluvoxamine (CYP1A2 inhibitor)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

16

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
      • Salt Lake City, Utah, United States, 84124
        • ICON Plc (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 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy participant, as determined by no clinically significant deviation from normal in medical history, physical examination, electrocardiograms (ECGs), and clinical laboratory determinations in the opinion of the investigator.
  • Body mass index of 18 to 32 kilograms per square meter (kg/m2), inclusive, and body weight ≥ 50 kg, at screening.
  • Normal renal function at screening as evidenced by an estimated glomerular filtration rate (GFR) > 80 milliliter/minute/1.732 meter square calculated with the Chronic Kidney Disease Epidemiology Collaboration formula.

Exclusion Criteria:

  • Any significant acute or chronic medical condition that presents a potential risk to the participant and/or may compromise the objectives of the study,
  • Any major surgery within 4 weeks of study drug administration
  • Participants who currently smoke, as well as those who have stopped smoking less than 6 months prior to dosing on Day 1.

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: Other
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: BMS-986165+Fluvoxamine
Drug: BMS-986165
Participants will receive BMS-986165.
Drug: Fluvoxamine
Participants will receive fluvoxamine.
Experimental: BMS-986165 only
Drug: BMS-986165
Participants will receive BMS-986165.
Experimental: Fluvoxamine only
Drug: Fluvoxamine
Participants will receive fluvoxamine.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Maximum observed plasma concentration (Cmax) of BMS-986165
Time Frame: 10 days
10 days
AUC(0-T) of BMS-986165
Time Frame: 10 days
10 days
AUC(INF) of BMS-986165
Time Frame: 10 days
10 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Fluvoxamine steady-state plasma concentrations
Time Frame: 10 days
10 days
Percentage of participants with Adverse events (AEs)
Time Frame: From screening up to end of drug treatment (Day 13)
From screening up to end of drug treatment (Day 13)
Percentage of participants with Serious Adverse events (SAEs) and Death
Time Frame: From screening up to end of drug treatment (Day 13)
From screening up to end of drug treatment (Day 13)
Percentage of participants with Adverse events (AEs) leading to discontinutation
Time Frame: From screening up to end of drug treatment (Day 13)
From screening up to end of drug treatment (Day 13)
Percentage of participants with clinical significant laboratory abnormalities vital sign measurements and ECGs
Time Frame: From screening up to end of drug treatment (Day 13)
From screening up to end of drug treatment (Day 13)

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)

May 1, 2019

Primary Completion (Actual)

May 27, 2019

Study Completion (Actual)

May 27, 2019

Study Registration Dates

First Submitted

April 26, 2019

First Submitted That Met QC Criteria

April 26, 2019

First Posted (Actual)

April 29, 2019

Study Record Updates

Last Update Posted (Actual)

November 17, 2021

Last Update Submitted That Met QC Criteria

November 9, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IM011-088

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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