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

Healthy Participants Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04956627
• Other study ID #: IM018-004
• Status: Completed
• Phase: Phase 1
• Start date: July 28, 2021
• Est. completion date: April 27, 2022

Study information

• Verified date: May 2022
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: April 27, 2022
• Est. primary completion date: April 27, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Participants

Intervention

Drug:
• BMS-986166
Specified dose on specified days
• Itraconazole
Specified dose on specified days
• Extended Phenytoin Sodium
Specified dose on specified days
• Gemfibrozil
Specified dose on specified days

Locations

Country	Name	City	State
United States	Hassman Research Institute	Berlin	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum observed plasma concentration (Cmax) of BMS-986166		Up to Day 22
Primary	Cmax of BMT-121795		Up to Day 22
Primary	Time of maximum observed plasma concentration (Tmax) of BMS-986166		Up to Day 22
Primary	Tmax of BMT-121795		Up to Day 22
Primary	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
Primary	AUC(0-T) of BMT-121795		Up to Day 22
Primary	Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC(INF))of BMS-986166		Up to Day 22
Primary	AUC(INF) of BMT-121795		Up to Day 22
Primary	Terminal plasma half-life (T-HALF) of BMS-986166		Up to Day 22
Primary	T-HALF of BMT-121795		Up to Day 22
Primary	Apparent total body clearance (CL/F) of BMS-986166		Up to Day 22
Primary	Apparent volume of distribution (Vz/F) of BMS-986166		Up to Day 22
Primary	Ratio of BMT-121795 Cmax to parent Cmax corrected for molecular weight (MR_Cmax)		Up to Day 22
Primary	Ratio of BMT-121795 AUC(0-T) to parent AUC(0-T) corrected for molecular weight (MR_AUC(0-T))		Up to Day 22
Primary	Ratio of BMT-121795 AUC(INF) to parent AUC(INF) corrected for molecular weight (MR_AUC(INF))		Up to Day 22
Secondary	Number of participants with Adverse Events (AEs)		Up to Day 55
Secondary	Number of participants with Serious Adverse Events (SAEs)		Up to Day 55
Secondary	Number of participants with physical examination abnormalities		Up to Day 55
Secondary	Number of participants with clinically significant changes in vital signs: Body temperature		Up to Day 55
Secondary	Number of participants with clinically significant changes in vital signs: Respiratory rate		Up to Day 55
Secondary	Number of participants with clinically significant changes in vital signs: Blood pressure		Up to Day 55
Secondary	Number of participants with clinically significant changes in vital signs: Heart rate		Up to Day 55
Secondary	Number of participants with clinically significant changes in ECG parameters: PR interval	PR interval is the time from the onset of the P wave to the start of the QRS complex	Up to Day 55
Secondary	Number of participants with clinically significant changes in ECG parameters: QRS	QRS can be defined as the electrical impulse as it spreads through the ventricles, indicating ventricular depolarization	Up to Day 55
Secondary	Number of participants with clinically significant changes in ECG parameters: QT interval	The QT interval is the time from the start of the Q wave to the end of the T wave	Up to Day 55
Secondary	Number of participants with clinically significant changes in ECG parameters: QTcF	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	Up to Day 55
Secondary	Number of participants with clinically significant changes in laboratory values: Hematology tests		Up to Day 55
Secondary	Number of participants with clinically significant changes in laboratory values: Chemistry tests		Up to Day 55
Secondary	Number of participants with clinically significant changes in laboratory values: Urinalysis		Up to Day 55

External Links

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