Ulcerative Colitis
Conditions
Brief summary
The purpose of this study is to understand if multiple oral doses of BMS-986166 are safe and well tolerated in healthy patients.
Interventions
DRUGBMS-986166
Specified dose on specified days
Specified dose on specified days
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 patients of non-childbearing potential or male patients as determined by medical history, physical examination, vital signs, 12-lead electrocardiogram (ECG), and clinical laboratory evaluations will be eligible to participate in the study * Body Mass Index (BMI) of 18.0 to 32.0 kg/m2, inclusive * This study permits the re-enrollment of a patient that has discontinued the study as a pre-treatment failure (i.e. patient has not been randomized / has not been treated). If re-enrolled, the patient must be re-consented
Exclusion criteria
* Women who are of childbearing potential, lactating or breastfeeding * Any significant acute or chronic medical illness judged to be clinically significant by the Investigator and/or Sponsor medical monitor * Patients with history of any type of heart disease, including ischemia, infarction, clinically significant arrhythmias, sinus syndrome, hypertension, symptomatic orthostatic hypotension, atrioventricular block of any degree, bradycardia, syncope, clinically significant ECG abnormalities, or any congenital heart disease * Patients with any acute or chronic bacterial, fungal (except history of tinea pedis or ongoing onychomycosis will not be exclusionary) or viral infection within the last 3 months prior to screening, as well as any febrile illness or viral infection within the last 3 months prior to screening, as well as any febrile illness of unknown origin within 14 days of screening * Patients who have received any live vaccines within 1 month of study drug administration, or who plan to have a live vaccine at any time during the study, including during the follow up period * Positive test for tuberculosis at screening * Past or current history of neurologic disorders, Guillain-Barré Syndrome, central or peripheral neuropathies, or past or current symptoms of sustained or recurrent paresthesia's (tingling), numbness, or neuropathic pain (burning, aching or stabbing) in any extremities Other protocol defined inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of All Adverse Events (AEs) | 77 days | measured by number of patients |
| Incidence of Serious Adverse Events (SAEs) | 77 days | measured by number of patients |
| Severity of all Adverse Events (AEs) | 77 days | measured by investigator |
| Change from baseline in physical examination findings | 77 days | measured by investigator |
| Change from baseline in electrocardiogram (ECG) results | 77 days | measured by ECG |
| Change from baseline in continuous cardiac monitoring data | 15 days | measured with external monitoring device |
| Change from baseline in clinical laboratory test results | 77 days | measured by serum chemistry, hematology, serology and urinalysis results |
| Change from baseline in body temperature | 77 days | measured in degrees Celsius or Fahrenheit |
| Change from baseline in respiratory rate | 77 days | measured by investigator |
| Change from baseline in seated blood pressure | 77 days | measured by investigator |
| Change from baseline in heart rate | 77 days | measured by investigator |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Area under the blood concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T)) | 77 days | measured by blood concentration versus time data |
| Area under the blood concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) | 77 days | measured by blood concentration versus time data |
| Apparent total clearance (CLT/F) | 77 days | measured by blood concentration versus time data |
| Mean heart rate (HR) | 15 days | Calculated from nadir HR to time-matched HR on Day -1 |
| Area under the concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] | 77 days | Used to calculate metabolite to parent molar ratio of pharmacokinetic parameter |
| Area under the concentration-time curve from time zero to the time of the last quantifiable concentration [AUC(0-T)] | 77 days | Used to calculate metabolite to parent molar ratio of pharmacokinetic parameter |
| Maximum observed concentration (Cmax) | 77 days | Used to calculate metabolite to parent molar ratio of pharmacokinetic parameter |
| Apparent steady state volume (Vz/F) | 77 days | measured by blood concentration versus time data |
| Largest decrease in HR from time-matched Day -1 baseline | 15 days | measured by investigator |
| Time to nadir HR from time 0 hour (predose) | 15 days | measured by investigator |
| Time to largest decrease HR from time 0 hour (predose) | 15 days | measured by investigator |
| Mean change from baseline in HR values by timepoint for BMS-986166-treated versus placebo-treated patients where the baseline is defined as time-matched Day -1 HR value | 15 days | measured by investigator |
| Largest percent decrease in absolute lymphocyte count (ALC) from time-matched Day -1 baseline | 35 days | measured by ALC |
| Time to largest percent reduction ALC from time 0 hour (predose) | 35 days | measured by ALC |
| Mean percent change from baseline in ALC values by timepoint for BMS-986166-treated versus placebo-treated patients where the baseline is defined as time-matched Day -1 ALC value | 77 days | measured by ALC |
| Maximum observed blood concentration (Cmax) | 77 days | measured by blood concentration versus time data |
| Time of maximum observed blood concentration (Tmax) | 77 days | measured by blood concentration versus time data |
| Terminal half-life (T-HALF) | 77 days | measured by blood concentration versus time data |
Countries
United States
Outcome results
None listed