Clinical trial NCT04536961: A Study to Evaluate the Drug Levels of BMS-986165 When Taken as Various Solid Tablet Prototypes by Healthy Participants
Official title: A Phase 1, Open-label, Crossover Study to Evaluate the Pharmacokinetics of BMS-986165 Administered as Various Prototypic Solid Tablet Formulations in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Keywords: Healthy volunteers
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2020-09-03
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility 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/exclusion criteria apply

Primary outcomes:
measure: Maximum observed plasma concentration (Cmax) of BMS-986165
timeFrame: Day 1 and Day 7
measure: Time of maximum observed plasma concentration (Tmax) of BMS-986165
timeFrame: Day 1 and Day 7
measure: Area under the plasma concentration-time curve from time zero to t (AUC (0-t)) of BMS-986165
timeFrame: Day 1 and Day 7
Secondary outcomes:
measure: Incidence of Nonserious Adverse Events (AEs)
timeFrame: Up to approximately 60 days (for Parts A & C), approximately 69 days (for Part B)
measure: Incidence of Serious Adverse Events (AEs)
timeFrame: Up to approximately 83 days (for Parts A & C), approximately 92 days (for Part B)
measure: Incidence of clinically significant changes in clinical laboratory results: Hematology tests
timeFrame: Up to approximately 53 days (for Parts A & C), approximately 62 days (for Part B)
measure: Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests
timeFrame: Up to approximately 53 days (for Parts A & C), approximately 62 days (for Part B)
measure: Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests
timeFrame: Up to approximately 53 days (for Parts A & C), approximately 62 days (for Part B)
measure: Incidence of clinically significant changes in vital signs: Blood pressure
timeFrame: Up to approximately 53 days (for Parts A & C), approximately 62 days (for Part B)
measure: Incidence of clinically significant changes in vital signs: Heart rate
timeFrame: Up to approximately 53 days (for Parts A & C), approximately 62 days (for Part B)
measure: Incidence of clinically significant changes in vital signs: Respiratory rate
timeFrame: Up to approximately 53 days (for Parts A & C), approximately 62 days (for Part B)
measure: Incidence of clinically significant changes in vital signs: Body temperature
timeFrame: Up to approximately 53 days (for Parts A & C), approximately 62 days (for Part B)
measure: Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QTcF
timeFrame: Up to approximately 53 days (for Parts A & C), approximately 62 days (for Part B)
measure: Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QRS
timeFrame: Up to approximately 53 days (for Parts A & C), approximately 62 days (for Part B)
measure: Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QT interval
timeFrame: Up to approximately 53 days (for Parts A & C), approximately 62 days (for Part B)
measure: Incidence of clinically significant changes in electrocardiogram (ECG) parameters: PR interval
timeFrame: Up to approximately 53 days (for Parts A & C), approximately 62 days (for Part B)
Other outcomes:
Locations:
city: Nottingham
country: United Kingdom
facility: Quotient Sciences Miami
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: