A Randomized, Double Blind Placebo-Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BMS-986166 in Healthy Subjects

Phase 1

Completed

Brief Summary: The primary purpose of this study is to determine if single doses of BMS-986166 are safe and well tolerated in healthy male subjects and female subjects of non-childbearing potential.

Recruitment & Eligibility

Inclusion Criteria

Healthy female subjects of non-childbearing potential or male subjects as determined by medical history, physical examination, vital signs, 12-lead electrocardiogram (ECG), and clinical laboratory evaluations
Ages 18 to 55 years
Female subjects must provide documentation of an acceptable method of surgical sterilization or meet the protocol criteria for menopause

Exclusion Criteria

Any acute or chronic medical illness judged to be clinically significant by the Investigator and/or Sponsor medical monitor
Any acute or chronic bacterial, fungal or viral infection, including tuberculosis, HIV, hepatitis B or hepatitis C, as defined in the protocol
History of heart disease, neurological disease, eye disorders or gastrointestinal disorders or surgery (including cholecystectomy)
Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECGs or clinical laboratory tests
Smoking or nicotine use, drug or alcohol abuse within 6 months of starting the study

Other protocol defined inclusion/exclusion criteria could apply

Arm && Interventions

Group	Intervention	Description
Dose Panel 4	BMS-986166	BMS-986166 or Placebo matching BMS-986166 Multiple ascending solid dose formulation as specified
Dose Panel 3	BMS-986166	BMS-986166 or Placebo matching BMS-986166 Single oral dose of solution as specified
Dose Panel 2	Placebo matching BMS-986166	BMS-986166 or Placebo matching BMS-986166 Single oral dose of solution as specified
Dose Panel 5a/b/c	BMS-986166	BMS-986166 Single oral solid dose formulation under fasting/fed/fasting with famotidine conditions
Dose Panel 4	Placebo matching BMS-986166	BMS-986166 or Placebo matching BMS-986166 Multiple ascending solid dose formulation as specified
Dose Panel 1	BMS-986166	BMS-986166 or Placebo matching BMS-986166 Single oral dose of solution as specified
Dose Panel 3	Placebo matching BMS-986166	BMS-986166 or Placebo matching BMS-986166 Single oral dose of solution as specified
Dose Panel 1	Placebo matching BMS-986166	BMS-986166 or Placebo matching BMS-986166 Single oral dose of solution as specified
Dose Panel 2	BMS-986166	BMS-986166 or Placebo matching BMS-986166 Single oral dose of solution as specified

Primary Outcome Measures

Name	Time	Method
Incidence of All Adverse Events (AEs)	Baseline Day -1 to Day 65
Incidence of Serious Adverse Events (SAEs)	Baseline Day -1 to Day 65
Severity of all All Adverse Events (AEs)	Baseline Day -1 to Day 65
Change from baseline in electrocardiogram(ECG) results	Baseline Day -1 to Day 35
Change from baseline in body temperature	Baseline Day -1 to Day 35
Change from baseline in respiratory rate	Baseline Day -1 to Day 35
Change from baseline in seated blood pressure	Baseline Day -1 to Day 35
Change from baseline in heart rate	Baseline Day -1 to Day 35
Change from baseline in clinical laboratory test results	Baseline Day -1 to Day 35	Clinical laboratory testing to include Chemistry analytes and Hematology analytes.
Change from baseline in continuous cardiac monitoring data	Baseline Day -1 to Day 35
Change from baseline in physical examination findings	Baseline Day -1 to Day 35

Secondary Outcome Measures

Name	Time	Method
Time to nadir HR from time 0 hour (predose)	Day -1 to Day 4
Largest decrease in HR from time-matched Day -1 baseline	Day -1 to Day 4
Mean difference in nadir heart rate (HR) and its time-matched HR on Day -1	Day -1 to Day 4
Percent reduction in HR at nadir from time-matched Day -1 HR value	Day -1 to Day 4
Mean change from baseline in HR values by timepoint for BMS-986166-treated versus placebo-treated subjects where the baseline is defined as time-matched Day -1 HR value	Day -1 to Day 7
Mean difference in absolute lymphocyte count (ALC) values and its time-matched ALC on Day -1 in BMS-986166- treated versus placebo-treated subjects	Day -1 to Day 4
Largest decrease in ALC from time-matched Day -1 baseline	Day -1 to Day 4
Time to nadir ALC from time 0 hour (predose)	Day -1 to Day 4
Percent reduction in ALC at nadir from time-matched Day -1 value	Day -1 to Day 4
Mean change from baseline in ALC values by timepoint for BMS-986166-treated versus placebo-treated subjects where the baseline is defined as time-matched Day -1 ALC value	Day -1 to Day 7