A Study to Assess the Effect of Itraconazole, Phenytoin and Gemfibrozil on the Drug Levels of BMS-986166 in Healthy Participants

May 11, 2022 updated by: Bristol-Myers Squibb

A Phase 1, Single-Center, Parallel-Group, Open-Label, Randomized, Drug-Drug Interaction Study to Assess the Effect of Itraconazole, Phenytoin, and Gemfibrozil on the Pharmacokinetics of a Single Oral Dose of BMS-986166 in Healthy Participants

The purpose of this study is to evaluate the effect of itraconazole, phenytoin and gemfibrozil on the drug levels of BMS-986166 and its active metabolite BMT-121795. Participants will be randomly assigned to one of four groups and will remain in the study clinic for the duration of treatment.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
15

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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
    • New Jersey
      • Berlin, New Jersey, United States, 08009
        • Hassman Research Institute

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Body weight of at least 55 kg.
  • Body mass index (BMI) of 19.0 to 32.0 kg/m², inclusive. BMI = weight (kg)/(height [m])².
  • Healthy female subjects of non-childbearing potential, or male subjects, as determined by medical history, physical examination, vital signs, 12-lead electrocardiogram (ECG), and clinical laboratory evaluations.

Exclusion Criteria:

  • Any significant acute or chronic medical illness or any other condition listed as a contraindication in the itraconazole, phenytoin, or gemfibrozil package inserts.
  • History of any type of heart disease, including ischemia, infarction, clinically significant arrhythmias, sinus syndrome, hypertension, symptomatic orthostatic hypotension, atrioventricular block of any degree, bradycardia, syncope, clinically significant 12-lead ECG abnormalities, or any congenital heart disease.
  • History of stroke or transient ischemic attacks.
  • History of asthma or chronic obstructive pulmonary disease diagnosed or treated within the past 5 years.

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: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: BMS-986166
Drug: BMS-986166
Specified dose on specified days
Experimental: BMS-986166 + Itraconazole
Drug: Itraconazole
Specified dose on specified days
Other Names:
  • Sporanox
Drug: BMS-986166
Specified dose on specified days
Experimental: BMS-986166 + Phenytoin
Drug: BMS-986166
Specified dose on specified days
Drug: Extended Phenytoin Sodium
Specified dose on specified days
Other Names:
  • Dilantin
Experimental: BMS-986166 + Gemfibrozil
Drug: BMS-986166
Specified dose on specified days
Drug: Gemfibrozil
Specified dose on specified days
Other Names:
  • Lopid

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Maximum observed plasma concentration (Cmax) of BMS-986166
Time Frame: Up to Day 22
Up to Day 22
Cmax of BMT-121795
Time Frame: Up to Day 22
Up to Day 22
Time of maximum observed plasma concentration (Tmax) of BMS-986166
Time Frame: Up to Day 22
Up to Day 22
Tmax of BMT-121795
Time Frame: Up to Day 22
Up to Day 22
Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T)) of BMS-986166
Time Frame: Up to Day 22
Up to Day 22
AUC(0-T) of BMT-121795
Time Frame: Up to Day 22
Up to Day 22
Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC(INF))of BMS-986166
Time Frame: Up to Day 22
Up to Day 22
AUC(INF) of BMT-121795
Time Frame: Up to Day 22
Up to Day 22
Terminal plasma half-life (T-HALF) of BMS-986166
Time Frame: Up to Day 22
Up to Day 22
T-HALF of BMT-121795
Time Frame: Up to Day 22
Up to Day 22
Apparent total body clearance (CL/F) of BMS-986166
Time Frame: Up to Day 22
Up to Day 22
Apparent volume of distribution (Vz/F) of BMS-986166
Time Frame: Up to Day 22
Up to Day 22
Ratio of BMT-121795 Cmax to parent Cmax corrected for molecular weight (MR_Cmax)
Time Frame: Up to Day 22
Up to Day 22
Ratio of BMT-121795 AUC(0-T) to parent AUC(0-T) corrected for molecular weight (MR_AUC(0-T))
Time Frame: Up to Day 22
Up to Day 22
Ratio of BMT-121795 AUC(INF) to parent AUC(INF) corrected for molecular weight (MR_AUC(INF))
Time Frame: Up to Day 22
Up to Day 22

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of participants with Adverse Events (AEs)
Time Frame: Up to Day 55
Up to Day 55
Number of participants with Serious Adverse Events (SAEs)
Time Frame: Up to Day 55
Up to Day 55
Number of participants with physical examination abnormalities
Time Frame: Up to Day 55
Up to Day 55
Number of participants with clinically significant changes in vital signs: Body temperature
Time Frame: Up to Day 55
Up to Day 55
Number of participants with clinically significant changes in vital signs: Respiratory rate
Time Frame: Up to Day 55
Up to Day 55
Number of participants with clinically significant changes in vital signs: Blood pressure
Time Frame: Up to Day 55
Up to Day 55
Number of participants with clinically significant changes in vital signs: Heart rate
Time Frame: Up to Day 55
Up to Day 55
Number of participants with clinically significant changes in ECG parameters: PR interval
Time Frame: Up to Day 55
PR interval is the time from the onset of the P wave to the start of the QRS complex
Up to Day 55
Number of participants with clinically significant changes in ECG parameters: QRS
Time Frame: Up to Day 55
QRS can be defined as the electrical impulse as it spreads through the ventricles, indicating ventricular depolarization
Up to Day 55
Number of participants with clinically significant changes in ECG parameters: QT interval
Time Frame: Up to Day 55
The QT interval is the time from the start of the Q wave to the end of the T wave
Up to Day 55
Number of participants with clinically significant changes in ECG parameters: QTcF
Time Frame: Up to Day 55
QTcF = Corrected QT interval using the Fridericia formula. QT interval is the time from the start of the Q wave to the end of the T wave
Up to Day 55
Number of participants with clinically significant changes in laboratory values: Hematology tests
Time Frame: Up to Day 55
Up to Day 55
Number of participants with clinically significant changes in laboratory values: Chemistry tests
Time Frame: Up to Day 55
Up to Day 55
Number of participants with clinically significant changes in laboratory values: Urinalysis
Time Frame: Up to Day 55
Up to Day 55

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 28, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 27, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 27, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 1, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 1, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 9, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 13, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 11, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IM018-004

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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