Clinical trial NCT04882150: A Study to Determine the Safety, Drug Levels and Drug Effects of BMS-986196 and Food and Formulation Effects on Relative Absorption Healthy Participants
Official title: A Phase 1, Randomized, Double-Blind, Placebo-controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BMS-986196 in Healthy Participants Including an Open-label Assessment of Food and Formulation Effects on the Relative Bioavailability of BMS-986196
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Participants
Keywords: Healthy participants
BMS-986196
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2021-05-11
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to characterize the safety, tolerability, drug levels and drug effects of BMS-986196 in healthy participants. In addition, an evaluation of food and formulation effects on BMS-986196 absorption will be performed.


Eligibility criteria: Inclusion Criteria:

* Women not of childbearing potential and men, ages 18 or local age of majority to 55 years, inclusive
* Healthy male and female non-Japanese participants without clinically significant deviation from normal in medical history, physical examination, electrocardiogram (ECG), and clinical laboratory determinations
* Body mass index (BMI) of 18 to 32 kg/m2, inclusive, and total body weight ≥ 50 kg

Exclusion Criteria:

* Known or suspected autoimmune disorder, including but not limited to rheumatoid arthritis, fibromyalgia, systemic lupus erythematosus, polymyalgia rheumatica, giant cell arteritis, Behcet's disease, dermatomyositis, MS, moderate to severe asthma, any autoimmune vasculitis, autoimmune hepatitis, or any other active autoimmune disease for which a participant requires medical follow-up or medical treatment
* Any history of known or suspected congenital or acquired immunodeficiency state or condition that would compromise the participant's immune status
* Presence of any factors that would predispose the participant to develop infection
* A history of bacterial or fungal meningitis within 1 year prior to screening
* A history of intracranial or intraspinal bleeding
* Known intracranial space-occupying mass, including meningioma

Other protocol-defined inclusion/exclusion criteria apply

Primary outcomes:
measure: Incidence of Adverse Events (AEs)
timeFrame: Up to 24 days
measure: Severity of AEs
timeFrame: Up to 24 days
measure: Causality of AEs
timeFrame: Up to 24 days
measure: Incidence of Serious Adverse Events (SAEs)
timeFrame: Up to 59 days
measure: Severity of SAEs
timeFrame: Up to 59 days
measure: Causality of SAEs
timeFrame: Up to 59 days
measure: Incidence of clinically significant changes in vital signs: Body temperature
timeFrame: Up to 24 days
measure: Incidence of clinically significant changes in vital signs: Respiratory rate
timeFrame: Up to 24 days
measure: Incidence of clinically significant changes in vital signs: Blood pressure
timeFrame: Up to 24 days
measure: Incidence of clinically significant changes in vital signs: Heart rate
timeFrame: Up to 24 days
measure: Incidence of clinically significant changes in weight
timeFrame: Up to 24 days
measure: Incidence of clinically significant changes in physical examination
timeFrame: Up to 24 days
measure: Incidence of clinically significant changes in ECG parameters: QT interval
timeFrame: Up to 24 days
measure: Incidence of clinically significant changes in ECG parameters: HR
timeFrame: Up to 24 days
measure: Incidence of clinically significant changes in clinical laboratory values: Hematology tests
timeFrame: Up to 24 days
measure: Incidence of clinically significant changes in clinical laboratory values: Clinical chemistry tests
timeFrame: Up to 24 days
measure: Incidence of clinically significant changes in clinical laboratory values: Coagulation tests
timeFrame: Up to 24 days
measure: Incidence of clinically significant changes in clinical laboratory values: Urinalysis tests
timeFrame: Up to 24 days
Secondary outcomes:
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: Local Institution - 0002
state: Utah
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: