Clinical trial NCT04305899: A Study to Compare the Taste and Levels in Blood Plasma of BMS-986165 When Taken as Different Formulations by Healthy Adult Participants
Official title: An Open-Label Cross-Over Study to Compare Bioavailability, Dose Proportionality, and Palatability of Single Doses of BMS-986165 Minitablet Pediatric Formulation in Fasted and Fed Conditions Relative to Single Doses of BMS-986165 Clinical Formulations In Healthy Adult Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Participants
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2020-03-12
Enrollment: 40
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 compare the taste, and the levels in blood plasma of different tablet formulations of BMS-986165 when taken by healthy adults.


Eligibility criteria: For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* Healthy participants, as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations in the opinion of the investigator
* Women and men must agree to follow specific methods of contraception, if applicable

Exclusion Criteria:

* Any significant acute or chronic 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
* Inability to tolerate oral medication
* History of allergy to BMS-986165 or related compounds

Other protocol-defined inclusion/exclusion criteria apply

Primary outcomes:
measure: Maximum concentration (Cmax) in plasma for BMS-986165
timeFrame: Up to 26 days
measure: Area under the plasma concentration-time curve from time 0 to the last quantifiable concentration (AUC(0-T)) in plasma for BMS-986165
timeFrame: Up to 26 days
measure: Area under the plasma concentration-time curve extrapolated to infinity (AUC(INF)) in plasma for BMS-986165
timeFrame: Up to 26 days
Secondary outcomes:
measure: Incidence of Adverse Events (AEs)
timeFrame: Up to 26 days
measure: Incidence of Serious Adverse Events (SAEs)
timeFrame: Up to 98 days
measure: Incidence of clinically significant changes in physical examination findings
timeFrame: Up to 68 days
measure: Incidence of clinically significant changes in vital signs: Weight
timeFrame: Up to 68 days
measure: Incidence of clinically significant changes in vital signs: Body temperature
timeFrame: Up to 68 days
measure: Incidence of clinically significant changes in vital signs: Respiratory rate
timeFrame: Up to 68 days
measure: Incidence of clinically significant changes in vital signs: Blood pressure
timeFrame: Up to 68 days
measure: Incidence of clinically significant changes in vital signs: Heart rate
timeFrame: Up to 68 days
measure: Incidence of clinically significant changes in electrocardiogram (ECG) parameters
timeFrame: Up to 68 days
measure: Incidence of clinically significant changes in clinical laboratory results: Hematology tests
timeFrame: Up to 68 days
measure: Incidence of clinically significant changes in clinical laboratory results: Clinical chemistry tests
timeFrame: Up to 68 days
measure: Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests
timeFrame: Up to 68 days
Other outcomes:
Locations:
city: Lenexa
country: United States
facility: PRA Health Sciences - Lenexa
state: Kansas
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: