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

Phase 1

Completed

• Conditions: Ulcerative Colitis
• Interventions: Drug: BMS-986166; Other: Placebo matching BMS-986166

• Registration Number: NCT03038711
• Lead Sponsor: Bristol-Myers Squibb

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-01-26
• Study First Submitted QC: 2017-01-30
• Study Start: 2017-02-01
• Study First Posted: 2017-02-01
• Primary Completion: 2017-08-10
• Study Completion: 2017-08-10
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-28
• Last Update Posted: 2019-01-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 213

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dose Panel 2	Placebo matching BMS-986166	BMS-986166 or Placebo matching BMS-986166
Dose Panel 3	Placebo matching BMS-986166	BMS-986166 or Placebo matching BMS-986166
Dose Panel 3	BMS-986166	BMS-986166 or Placebo matching BMS-986166
Dose Panel 1	Placebo matching BMS-986166	BMS-986166 or Placebo matching BMS-986166
Dose Panel 1	BMS-986166	BMS-986166 or Placebo matching BMS-986166
Dose Panel 2	BMS-986166	BMS-986166 or Placebo matching BMS-986166

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Mean heart rate (HR)	15 days	Calculated from nadir HR to time-matched HR on Day -1
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
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
Apparent steady state volume (Vz/F)	77 days	measured by blood concentration versus time data
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

Trial Locations

Locations (1)

PPD Development, LLC; 🇺🇸 Austin, Texas, United States