Healthy
Conditions
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.
Interventions
Sponsors
Bristol-Myers Squibb
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com 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/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in physical examination findings | Baseline Day -1 to Day 35 | — |
| 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 | — |
Secondary
| Measure | Time frame |
|---|---|
| Largest decrease in HR from time-matched Day -1 baseline | Day -1 to Day 4 |
| Time to nadir HR from time 0 hour (predose) | 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 |
| Mean difference in nadir heart rate (HR) and its time-matched HR on Day -1 | Day -1 to Day 4 |
Countries
United States
Outcome results
None listed