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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03038711
• Date of registration: 26/01/2017
• Prospective Registration: Yes
• Primary sponsor: Bristol-Myers Squibb
• Public title: A Multiple Dose Study to Assess the Safety and Tolerability of BMS-986166 in Healthy Volunteers
• Scientific 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
• Date of first enrolment: February 1, 2017
• Target sample size: 213
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03038711
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Screening. Masking: Double (Participant, Investigator).
• Phase: Phase 1

Countries of recruitment

United States

Contacts

• Name: Bristol-Myers Squibb
• Affiliation: Bristol-Myers Squibb

Key inclusion & exclusion 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/exclusion criteria could apply



Age minimum: 18 Years
Age maximum: 55 Years
Gender: All

Health Condition(s) or Problem(s) studied

Ulcerative Colitis

Intervention(s)

Other: Placebo matching BMS-986166

Drug: BMS-986166

Primary Outcome(s)

Change from baseline in continuous cardiac monitoring data [Time Frame: 15 days]

Change from baseline in respiratory rate [Time Frame: 77 days]

Change from baseline in heart rate [Time Frame: 77 days]

Change from baseline in physical examination findings [Time Frame: 77 days]

Change from baseline in body temperature [Time Frame: 77 days]

Change from baseline in seated blood pressure [Time Frame: 77 days]

Change from baseline in electrocardiogram (ECG) results [Time Frame: 77 days]

Incidence of Serious Adverse Events (SAEs) [Time Frame: 77 days]

Change from baseline in clinical laboratory test results [Time Frame: 77 days]

Severity of all Adverse Events (AEs) [Time Frame: 77 days]

Incidence of All Adverse Events (AEs) [Time Frame: 77 days]

Secondary Outcome(s)

Time to largest percent reduction ALC from time 0 hour (predose) [Time Frame: 35 days]

Mean heart rate (HR) [Time Frame: 15 days]

Apparent total clearance (CLT/F) [Time Frame: 77 days]

Largest decrease in HR from time-matched Day -1 baseline [Time Frame: 15 days]

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 [Time Frame: 77 days]

Area under the concentration-time curve from time zero to the time of the last quantifiable concentration [AUC(0-T)] [Time Frame: 77 days]

Largest percent decrease in absolute lymphocyte count (ALC) from time-matched Day -1 baseline [Time Frame: 35 days]

Terminal half-life (T-HALF) [Time Frame: 77 days]

Area under the blood concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T)) [Time Frame: 77 days]

Maximum observed blood concentration (Cmax) [Time Frame: 77 days]

Time of maximum observed blood concentration (Tmax) [Time Frame: 77 days]

Area under the concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] [Time Frame: 77 days]

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 [Time Frame: 15 days]

Time to nadir HR from time 0 hour (predose) [Time Frame: 15 days]

Time to largest decrease HR from time 0 hour (predose) [Time Frame: 15 days]

Apparent steady state volume (Vz/F) [Time Frame: 77 days]

Area under the blood concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) [Time Frame: 77 days]

Maximum observed concentration (Cmax) [Time Frame: 77 days]

Secondary ID(s)

IM018-003

Source(s) of Monetary Support

Please refer to primary and secondary sponsors