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

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 1

Conditions: Healthy Participants

Treatments: Drug: Gemfibrozil; Drug: BMS-986166; Drug: Itraconazole; Drug: Extended Phenytoin Sodium

Study type: Interventional

Funder types: Industry

Identifiers

NCT04956627

IM018-004

Details and patient eligibility

About

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.

Enrollment: 15 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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15 participants in 4 patient groups

BMS-986166

Experimental group

Treatment:

Drug: BMS-986166

BMS-986166 + Itraconazole

Experimental group

Treatment:

Drug: Itraconazole

Drug: BMS-986166

BMS-986166 + Phenytoin

Experimental group

Treatment:

Drug: Extended Phenytoin Sodium

Drug: BMS-986166

BMS-986166 + Gemfibrozil

Experimental group

Treatment:

Drug: BMS-986166

Drug: Gemfibrozil