A Multiple Dose Study to Assess the Safety and Tolerability of BMS-986166 in Healthy Volunteers

Ulcerative Colitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03038711
• Other study ID #: IM018-003
• Status: Completed
• Phase: Phase 1
• Start date: February 1, 2017
• Est. completion date: August 10, 2017

Study information

• Verified date: January 2019
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to understand if multiple oral doses of BMS-986166 are safe and well tolerated in healthy patients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 213
• Est. completion date: August 10, 2017
• Est. primary completion date: August 10, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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/exclusion criteria could apply

Related Conditions & MeSH terms

• Colitis, Ulcerative
• Ulcerative Colitis

Intervention

Drug:
• BMS-986166
Specified dose on specified days

Other:
• Placebo matching BMS-986166
Specified dose on specified days

Locations

Country	Name	City	State
United States	PPD Development, LLC	Austin	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of All Adverse Events (AEs)	measured by number of patients	77 days
Primary	Incidence of Serious Adverse Events (SAEs)	measured by number of patients	77 days
Primary	Severity of all Adverse Events (AEs)	measured by investigator	77 days
Primary	Change from baseline in physical examination findings	measured by investigator	77 days
Primary	Change from baseline in electrocardiogram (ECG) results	measured by ECG	77 days
Primary	Change from baseline in continuous cardiac monitoring data	measured with external monitoring device	15 days
Primary	Change from baseline in clinical laboratory test results	measured by serum chemistry, hematology, serology and urinalysis results	77 days
Primary	Change from baseline in body temperature	measured in degrees Celsius or Fahrenheit	77 days
Primary	Change from baseline in respiratory rate	measured by investigator	77 days
Primary	Change from baseline in seated blood pressure	measured by investigator	77 days
Primary	Change from baseline in heart rate	measured by investigator	77 days
Secondary	Mean heart rate (HR)	Calculated from nadir HR to time-matched HR on Day -1	15 days
Secondary	Largest decrease in HR from time-matched Day -1 baseline	measured by investigator	15 days
Secondary	Time to nadir HR from time 0 hour (predose)	measured by investigator	15 days
Secondary	Time to largest decrease HR from time 0 hour (predose)	measured by investigator	15 days
Secondary	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	measured by investigator	15 days
Secondary	Largest percent decrease in absolute lymphocyte count (ALC) from time-matched Day -1 baseline	measured by ALC	35 days
Secondary	Time to largest percent reduction ALC from time 0 hour (predose)	measured by ALC	35 days
Secondary	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	measured by ALC	77 days
Secondary	Maximum observed blood concentration (Cmax)	measured by blood concentration versus time data	77 days
Secondary	Time of maximum observed blood concentration (Tmax)	measured by blood concentration versus time data	77 days
Secondary	Terminal half-life (T-HALF)	measured by blood concentration versus time data	77 days
Secondary	Area under the blood concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T))	measured by blood concentration versus time data	77 days
Secondary	Area under the blood concentration-time curve from time zero extrapolated to infinite time (AUC(INF))	measured by blood concentration versus time data	77 days
Secondary	Apparent total clearance (CLT/F)	measured by blood concentration versus time data	77 days
Secondary	Apparent steady state volume (Vz/F)	measured by blood concentration versus time data	77 days
Secondary	Area under the concentration-time curve from time zero extrapolated to infinite time [AUC(INF)]	Used to calculate metabolite to parent molar ratio of pharmacokinetic parameter	77 days
Secondary	Area under the concentration-time curve from time zero to the time of the last quantifiable concentration [AUC(0-T)]	Used to calculate metabolite to parent molar ratio of pharmacokinetic parameter	77 days
Secondary	Maximum observed concentration (Cmax)	Used to calculate metabolite to parent molar ratio of pharmacokinetic parameter	77 days

External Links

•   BMS Clinical Trial Patient Recruiting
•   FDA Safety Alerts and Recalls
•   Investigator Inquiry Form