A Study to Evaluate the Drug Levels of BMS-986165 When Taken as Various Solid Tablet Prototypes by Healthy Participants
Phase 1
Completed
- Conditions
- Healthy Volunteers
- Interventions
- Registration Number
- NCT04536961
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
The purpose of this study is to evaluate the drug levels of BMS-986165 in when taken by mouth as various solid tablet prototypes, by healthy participants.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 56
Inclusion Criteria
- No clinically significant deviation from normal in medical history, physical examination, electrocardiograms (ECGs), and clinical laboratory determinations.
- Body mass index (BMI) of 18.0 to 32.0 kg/m2, inclusive, and total body weight ≥50 kg (110 lb). BMI = weight (kg)/(height [m])2 at screening.
- Willing and able to consume 4 units of alcohol (Part B only)
- A negative polymerase chain reaction (PCR) test for coronavirus disease 2019 (COVID-19) at screening and admission
- Males and females must agree to follow specific methods of contraception, if applicable
Exclusion Criteria
- Current or recent (within 3 months or 90 days of study drug administration) clinically significant gastrointestinal disease that, in the opinion of the investigator or medical monitor, could impact upon the absorption of study drug
- Any medical condition that presents a potential risk to the participant and/or may compromise the objectives of the study, including a history of or active liver disease.
- Clinically significant history or presence of acute or chronic bacterial, fungal, or viral infection (eg, pneumonia, septicemia) within the 3 months or 90 days prior to screening.
Other protocol-defined inclusion/exclusion criteria apply
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Part A: Reference Treatment Reference Treatment- BMS-986165-01 - Part B: Treatment 5 Alcohol - Part A Prototype Prototype BMS-986165 - Part C: Prototype Prototype BMS-986165 - Part B: Treatment 1 Prototype BMS-986165 - Part B: Treatment 2 Prototype BMS-986165 - Part B: Treatment 3 Prototype BMS-986165 - Part B: Treatment 4 Prototype BMS-986165 - Part C Reference Treatment Reference Treatment- BMS-986165-01 - Part B: Treatment 5 Prototype BMS-986165 - Part B: Treatment 4 Famotidine -
- Primary Outcome Measures
Name Time Method Time of maximum observed plasma concentration (Tmax) of BMS-986165 Day 1 and Day 7 Maximum observed plasma concentration (Cmax) of BMS-986165 Day 1 and Day 7 Area under the plasma concentration-time curve from time zero to t (AUC (0-t)) of BMS-986165 Day 1 and Day 7 Part A, B, C
- Secondary Outcome Measures
Name Time Method Incidence of Serious Adverse Events (AEs) Up to approximately 83 days (for Parts A & C), approximately 92 days (for Part B) Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QTcF Up to approximately 53 days (for Parts A & C), approximately 62 days (for Part B) 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.
Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QT interval Up to approximately 53 days (for Parts A & C), approximately 62 days (for Part B) The QT interval is the time from the start of the Q wave to the end of the T wave.
Incidence of Nonserious Adverse Events (AEs) Up to approximately 60 days (for Parts A & C), approximately 69 days (for Part B) Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests Up to approximately 53 days (for Parts A & C), approximately 62 days (for Part B) Incidence of clinically significant changes in vital signs: Respiratory rate Up to approximately 53 days (for Parts A & C), approximately 62 days (for Part B) Incidence of clinically significant changes in electrocardiogram (ECG) parameters: PR interval Up to approximately 53 days (for Parts A & C), approximately 62 days (for Part B) PR interval is the time from the onset of the P wave to the start of the QRS complex
Incidence of clinically significant changes in vital signs: Body temperature Up to approximately 53 days (for Parts A & C), approximately 62 days (for Part B) Incidence of clinically significant changes in clinical laboratory results: Hematology tests Up to approximately 53 days (for Parts A & C), approximately 62 days (for Part B) Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests Up to approximately 53 days (for Parts A & C), approximately 62 days (for Part B) Incidence of clinically significant changes in vital signs: Blood pressure Up to approximately 53 days (for Parts A & C), approximately 62 days (for Part B) Incidence of clinically significant changes in vital signs: Heart rate Up to approximately 53 days (for Parts A & C), approximately 62 days (for Part B) Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QRS Up to approximately 53 days (for Parts A & C), approximately 62 days (for Part B) QRS can be defined as the electrical impulse as it spreads through the ventricles, indicating ventricular depolarization
Trial Locations
- Locations (1)
Quotient Sciences Miami
🇬🇧Nottingham, United Kingdom