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Completed

NCT Number: NCT04956627

A Study to Assess the Effect of Itraconazole, Phenytoin and Gemfibrozil on the Drug Levels 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.

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Key information

Conditions

Healthy Participants

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Hassman Research Institute

Berlin, New Jersey, 08009, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BMS-986166

Drug

Specified dose on specified days

Itraconazole

Drug

Specified dose on specified days

Other names: Sporanox

Extended Phenytoin Sodium

Drug

Specified dose on specified days

Other names: Dilantin

Gemfibrozil

Drug

Specified dose on specified days

Other names: Lopid

Primary outcomes

  1. Maximum observed plasma concentration (Cmax) of BMS-986166

    Time frame: Up to Day 22

  2. Cmax of BMT-121795

    Time frame: Up to Day 22

  3. Time of maximum observed plasma concentration (Tmax) of BMS-986166

    Time frame: Up to Day 22

  4. Tmax of BMT-121795

    Time frame: Up to Day 22

  5. 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

  6. AUC(0-T) of BMT-121795

    Time frame: Up to Day 22

  7. 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

  8. AUC(INF) of BMT-121795

    Time frame: Up to Day 22

  9. Terminal plasma half-life (T-HALF) of BMS-986166

    Time frame: Up to Day 22

  10. T-HALF of BMT-121795

    Time frame: Up to Day 22

  11. Apparent total body clearance (CL/F) of BMS-986166

    Time frame: Up to Day 22

  12. Apparent volume of distribution (Vz/F) of BMS-986166

    Time frame: Up to Day 22

  13. Ratio of BMT-121795 Cmax to parent Cmax corrected for molecular weight (MR_Cmax)

    Time frame: Up to Day 22

  14. 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

  15. Ratio of BMT-121795 AUC(INF) to parent AUC(INF) corrected for molecular weight (MR_AUC(INF))

    Time frame: Up to Day 22

Secondary outcomes

  1. Number of participants with Adverse Events (AEs)

    Time frame: Up to Day 55

  2. Number of participants with Serious Adverse Events (SAEs)

    Time frame: Up to Day 55

  3. Number of participants with physical examination abnormalities

    Time frame: Up to Day 55

  4. Number of participants with clinically significant changes in vital signs: Body temperature

    Time frame: Up to Day 55

  5. Number of participants with clinically significant changes in vital signs: Respiratory rate

    Time frame: Up to Day 55

  6. Number of participants with clinically significant changes in vital signs: Blood pressure

    Time frame: Up to Day 55

  7. Number of participants with clinically significant changes in vital signs: Heart rate

    Time frame: Up to Day 55

  8. 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

  9. 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

  10. 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

  11. 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

  12. Number of participants with clinically significant changes in laboratory values: Hematology tests

    Time frame: Up to Day 55

  13. Number of participants with clinically significant changes in laboratory values: Chemistry tests

    Time frame: Up to Day 55

  14. Number of participants with clinically significant changes in laboratory values: Urinalysis

    Time frame: Up to Day 55

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jul 9, 2021
Registry last updated
May 13, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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