Local Institution - 0002
Salt Lake City, Utah, 84124, United States
Completed
NCT Number: 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
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.
Completed
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Notify MeKey information
Conditions
Age range
18 year–55 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 1
Primary location
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
BMS-986196
DrugSpecified dose on specified days
Placebo
OtherSpecified dose on specified days
Primary outcomes
-
Incidence of Adverse Events (AEs)
Time frame: Up to 24 days
-
Severity of AEs
Time frame: Up to 24 days
-
Causality of AEs
Time frame: Up to 24 days
-
Incidence of Serious Adverse Events (SAEs)
Time frame: Up to 59 days
-
Severity of SAEs
Time frame: Up to 59 days
-
Causality of SAEs
Time frame: Up to 59 days
-
Incidence of clinically significant changes in vital signs: Body temperature
Time frame: Up to 24 days
-
Incidence of clinically significant changes in vital signs: Respiratory rate
Time frame: Up to 24 days
-
Incidence of clinically significant changes in vital signs: Blood pressure
Time frame: Up to 24 days
-
Incidence of clinically significant changes in vital signs: Heart rate
Time frame: Up to 24 days
-
Incidence of clinically significant changes in weight
Time frame: Up to 24 days
-
Incidence of clinically significant changes in physical examination
Time frame: Up to 24 days
-
Incidence of clinically significant changes in ECG parameters: QT interval
Time frame: Up to 24 days
-
Incidence of clinically significant changes in ECG parameters: HR
Time frame: Up to 24 days
-
Incidence of clinically significant changes in clinical laboratory values: Hematology tests
Time frame: Up to 24 days
-
Incidence of clinically significant changes in clinical laboratory values: Clinical chemistry tests
Time frame: Up to 24 days
-
Incidence of clinically significant changes in clinical laboratory values: Coagulation tests
Time frame: Up to 24 days
-
Incidence of clinically significant changes in clinical laboratory values: Urinalysis tests
Time frame: Up to 24 days
Sponsors and collaborators
Lead sponsor
Bristol-Myers Squibb
Industry
Registry information
Official study 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
Important dates
- Study start
- 2021
- Primary completion
- 2022
- Study completion
- 2022
- First posted
- May 11, 2021
- Registry last updated
- Jan 12, 2023
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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