Healthy Volunteers
Conditions
Keywords
Healthy volunteers
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.
Interventions
DRUGReference Treatment- BMS-986165-01
Specified dose on specified days
DRUGPrototype BMS-986165
Specified dose on specified days
DRUGFamotidine
Specified dose on specified days
OTHERAlcohol
Specified quantity on specified days
Sponsors
Bristol-Myers Squibb
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com 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/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum observed plasma concentration (Cmax) of BMS-986165 | Day 1 and Day 7 | — |
| Time of maximum observed plasma concentration (Tmax) 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
| Measure | Time frame | Description |
|---|---|---|
| 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 Nonserious Adverse Events (AEs) | Up to approximately 60 days (for Parts A & C), approximately 69 days (for Part B) | — |
| 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 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 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 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 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: 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 |
| 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 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. |
Countries
United Kingdom
Outcome results
None listed