Clinical trial NCT04956627: A Study to Assess the Effect of Itraconazole, Phenytoin and Gemfibrozil on the Drug Levels of BMS-986166 in Healthy Participants
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Participants
Keywords: Healthy Participants
BMS-986166
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2021-07-09
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Maximum observed plasma concentration (Cmax) of BMS-986166
timeFrame: Up to Day 22
measure: Cmax of BMT-121795
timeFrame: Up to Day 22
measure: Time of maximum observed plasma concentration (Tmax) of BMS-986166
timeFrame: Up to Day 22
measure: Tmax of BMT-121795
timeFrame: Up to Day 22
measure: Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T)) of BMS-986166
timeFrame: Up to Day 22
measure: AUC(0-T) of BMT-121795
timeFrame: Up to Day 22
measure: Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC(INF))of BMS-986166
timeFrame: Up to Day 22
measure: AUC(INF) of BMT-121795
timeFrame: Up to Day 22
measure: Terminal plasma half-life (T-HALF) of BMS-986166
timeFrame: Up to Day 22
measure: T-HALF of BMT-121795
timeFrame: Up to Day 22
measure: Apparent total body clearance (CL/F) of BMS-986166
timeFrame: Up to Day 22
measure: Apparent volume of distribution (Vz/F) of BMS-986166
timeFrame: Up to Day 22
measure: Ratio of BMT-121795 Cmax to parent Cmax corrected for molecular weight (MR_Cmax)
timeFrame: Up to Day 22
measure: Ratio of BMT-121795 AUC(0-T) to parent AUC(0-T) corrected for molecular weight (MR_AUC(0-T))
timeFrame: Up to Day 22
measure: Ratio of BMT-121795 AUC(INF) to parent AUC(INF) corrected for molecular weight (MR_AUC(INF))
timeFrame: Up to Day 22
Secondary outcomes:
measure: Number of participants with Adverse Events (AEs)
timeFrame: Up to Day 55
measure: Number of participants with Serious Adverse Events (SAEs)
timeFrame: Up to Day 55
measure: Number of participants with physical examination abnormalities
timeFrame: Up to Day 55
measure: Number of participants with clinically significant changes in vital signs: Body temperature
timeFrame: Up to Day 55
measure: Number of participants with clinically significant changes in vital signs: Respiratory rate
timeFrame: Up to Day 55
measure: Number of participants with clinically significant changes in vital signs: Blood pressure
timeFrame: Up to Day 55
measure: Number of participants with clinically significant changes in vital signs: Heart rate
timeFrame: Up to Day 55
measure: Number of participants with clinically significant changes in ECG parameters: PR interval
timeFrame: Up to Day 55
measure: Number of participants with clinically significant changes in ECG parameters: QRS
timeFrame: Up to Day 55
measure: Number of participants with clinically significant changes in ECG parameters: QT interval
timeFrame: Up to Day 55
measure: Number of participants with clinically significant changes in ECG parameters: QTcF
timeFrame: Up to Day 55
measure: Number of participants with clinically significant changes in laboratory values: Hematology tests
timeFrame: Up to Day 55
measure: Number of participants with clinically significant changes in laboratory values: Chemistry tests
timeFrame: Up to Day 55
measure: Number of participants with clinically significant changes in laboratory values: Urinalysis
timeFrame: Up to Day 55
Other outcomes:
Locations:
city: Berlin
country: United States
facility: Hassman Research Institute
state: New Jersey
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: