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

NCT04956627 | Completed Phase 1 FDA Drug

• 1 other identifier: IM018-004
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy Participants

Keywords

Healthy Participants; BMS-986166

Outcome Measures

Primary Outcomes (15)

• Maximum observed plasma concentration (Cmax) of BMS-986166

  Up to Day 22

• Cmax of BMT-121795

  Up to Day 22

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

  Up to Day 22

• Tmax of BMT-121795

  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

  Up to Day 22

• AUC(0-T) of BMT-121795

  Up to Day 22

• Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC(INF))of BMS-986166

  Up to Day 22

• AUC(INF) of BMT-121795

  Up to Day 22

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

  Up to Day 22

• T-HALF of BMT-121795

  Up to Day 22

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

  Up to Day 22

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

  Up to Day 22

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

  Up to Day 22

• Ratio of BMT-121795 AUC(0-T) to parent AUC(0-T) corrected for molecular weight (MR_AUC(0-T))

  Up to Day 22

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

  Up to Day 22

Secondary Outcomes (14)

• Number of participants with Adverse Events (AEs)

  Up to Day 55

• Number of participants with Serious Adverse Events (SAEs)

  Up to Day 55

• Number of participants with physical examination abnormalities

  Up to Day 55

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

  Up to Day 55

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

  Up to Day 55

Study Arms (4)

BMS-986166

EXPERIMENTAL

Drug: BMS-986166

BMS-986166 + Itraconazole

EXPERIMENTAL

Drug: BMS-986166; Drug: Itraconazole

BMS-986166 + Phenytoin

EXPERIMENTAL

Drug: BMS-986166; Drug: Extended Phenytoin Sodium

BMS-986166 + Gemfibrozil

EXPERIMENTAL

Drug: BMS-986166; Drug: Gemfibrozil

Interventions

BMS-986166 DRUG

Specified dose on specified days

BMS-986166; BMS-986166 + Gemfibrozil; BMS-986166 + Itraconazole; BMS-986166 + Phenytoin

Itraconazole DRUG

Specified dose on specified days

Also known as: Sporanox

BMS-986166 + Itraconazole

Extended Phenytoin Sodium DRUG

Specified dose on specified days

Also known as: Dilantin

BMS-986166 + Phenytoin

Gemfibrozil DRUG

Specified dose on specified days

Also known as: Lopid

BMS-986166 + Gemfibrozil

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (1)

Hassman Research Institute

Berlin, New Jersey, 08009, United States

Location

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting
• Investigator Inquiry Form
• FDA Safety Alerts and Recalls

MeSH Terms

Interventions

BMS-986166; Itraconazole; Phenytoin; Gemfibrozil

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperazines; Hydantoins; Imidazolidines; Imidazoles; Fibric Acids; Isobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Pentanoic Acids; Valerates; Phenyl Ethers; Ethers; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Fatty Acids, Volatile; Fatty Acids; Lipids

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2021
• First Posted: July 9, 2021
• Study Start: July 28, 2021
• Primary Completion: April 27, 2022
• Study Completion: April 27, 2022
• Last Updated: May 13, 2022

Record last verified: 2022-05

Locations

US (1)