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

• Status: Recruiting
• Trial end date: 2022-01-19
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Bristol-Myers Squibb
• Treatments: Gemfibrozil; Itraconazole; Phenytoin

Criteria

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit: www.BMSStudyConnect.com

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 may apply.