Clinical trial NCT02790125: A Randomized, Double Blind Placebo-Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BMS-986166 in Healthy Subjects
Official title: A Randomized, Double Blind Placebo-Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BMS-986166 in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2016-06-03
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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.


Eligibility 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/exclusion criteria could apply

Primary outcomes:
measure: Incidence of All Adverse Events (AEs)
timeFrame: Baseline Day -1 to Day 65
measure: Incidence of Serious Adverse Events (SAEs)
timeFrame: Baseline Day -1 to Day 65
measure: Severity of all All Adverse Events (AEs)
timeFrame: Baseline Day -1 to Day 65
measure: Change from baseline in electrocardiogram(ECG) results
timeFrame: Baseline Day -1 to Day 35
measure: Change from baseline in body temperature
timeFrame: Baseline Day -1 to Day 35
measure: Change from baseline in respiratory rate
timeFrame: Baseline Day -1 to Day 35
measure: Change from baseline in seated blood pressure
timeFrame: Baseline Day -1 to Day 35
measure: Change from baseline in heart rate
timeFrame: Baseline Day -1 to Day 35
measure: Change from baseline in clinical laboratory test results
timeFrame: Baseline Day -1 to Day 35
measure: Change from baseline in continuous cardiac monitoring data
timeFrame: Baseline Day -1 to Day 35
measure: Change from baseline in physical examination findings
timeFrame: Baseline Day -1 to Day 35
Secondary outcomes:
measure: Mean difference in nadir heart rate (HR) and its time-matched HR on Day -1
timeFrame: Day -1 to Day 4
measure: Largest decrease in HR from time-matched Day -1 baseline
timeFrame: Day -1 to Day 4
measure: Time to nadir HR from time 0 hour (predose)
timeFrame: Day -1 to Day 4
measure: Percent reduction in HR at nadir from time-matched Day -1 HR value
timeFrame: Day -1 to Day 4
measure: 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
timeFrame: Day -1 to Day 7
measure: Mean difference in absolute lymphocyte count (ALC) values and its time-matched ALC on Day -1 in BMS-986166- treated versus placebo-treated subjects
timeFrame: Day -1 to Day 4
measure: Largest decrease in ALC from time-matched Day -1 baseline
timeFrame: Day -1 to Day 4
measure: Time to nadir ALC from time 0 hour (predose)
timeFrame: Day -1 to Day 4
measure: Percent reduction in ALC at nadir from time-matched Day -1 value
timeFrame: Day -1 to Day 4
measure: 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
timeFrame: Day -1 to Day 7
Other outcomes:
Locations:
city: Austin
country: United States
facility: PPD Development, LLC
state: Texas
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
citation: Singhal S, Girgis IG, Xie J, Dutta S, Shevell DE, Throup J. The safety and pharmacokinetics of a novel, selective S1P1R modulator in healthy participants. Expert Opin Investig Drugs. 2020 Apr;29(4):411-422. doi: 10.1080/13543784.2020.1742322.