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

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: BMS-986166; Drug: Placebo matching BMS-986166

• Study Type: Interventional
• Enrollment (Anticipated): 66
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Texas
    • Austin, Texas, United States, 78744
      • Ppd Development, Llc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 53 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dose Panel 1; BMS-986166 or Placebo matching BMS-986166 Single oral dose of solution as specified	Drug: BMS-986166; Drug: Placebo matching BMS-986166
Experimental: Dose Panel 2; BMS-986166 or Placebo matching BMS-986166 Single oral dose of solution as specified	Drug: BMS-986166; Drug: Placebo matching BMS-986166
Experimental: Dose Panel 3; BMS-986166 or Placebo matching BMS-986166 Single oral dose of solution as specified	Drug: BMS-986166; Drug: Placebo matching BMS-986166
Experimental: Dose Panel 4; BMS-986166 or Placebo matching BMS-986166 Multiple ascending solid dose formulation as specified	Drug: BMS-986166; Drug: Placebo matching BMS-986166
Experimental: Dose Panel 5a/b/c; BMS-986166 Single oral solid dose formulation under fasting/fed/fasting with famotidine conditions	Drug: BMS-986166

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of All Adverse Events (AEs)		Baseline Day -1 to Day 65
Incidence of Serious Adverse Events (SAEs)		Baseline Day -1 to Day 65
Severity of all All Adverse Events (AEs)		Baseline Day -1 to Day 65
Change from baseline in electrocardiogram(ECG) results		Baseline Day -1 to Day 35
Change from baseline in body temperature		Baseline Day -1 to Day 35
Change from baseline in respiratory rate		Baseline Day -1 to Day 35
Change from baseline in seated blood pressure		Baseline Day -1 to Day 35
Change from baseline in heart rate		Baseline Day -1 to Day 35
Change from baseline in clinical laboratory test results	Clinical laboratory testing to include Chemistry analytes and Hematology analytes.	Baseline Day -1 to Day 35
Change from baseline in continuous cardiac monitoring data		Baseline Day -1 to Day 35
Change from baseline in physical examination findings		Baseline Day -1 to Day 35

Secondary Outcome Measures

Outcome Measure	Time Frame
Mean difference in nadir heart rate (HR) and its time-matched HR on Day -1	Day -1 to Day 4
Largest decrease in HR from time-matched Day -1 baseline	Day -1 to Day 4
Time to nadir HR from time 0 hour (predose)	Day -1 to Day 4
Percent reduction in HR at nadir from time-matched Day -1 HR value	Day -1 to Day 4
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	Day -1 to Day 7
Mean difference in absolute lymphocyte count (ALC) values and its time-matched ALC on Day -1 in BMS-986166- treated versus placebo-treated subjects	Day -1 to Day 4
Largest decrease in ALC from time-matched Day -1 baseline	Day -1 to Day 4
Time to nadir ALC from time 0 hour (predose)	Day -1 to Day 4
Percent reduction in ALC at nadir from time-matched Day -1 value	Day -1 to Day 4
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	Day -1 to Day 7

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb

Publications and helpful links

General Publications

• 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.

Helpful Links

• BMS Clinical Trial Patient Recruiting

Study record dates

Study Major Dates

• Study Start (Actual): July 28, 2016
• Primary Completion (Actual): November 7, 2017
• Study Completion (Actual): November 7, 2017

Study Registration Dates

• First Submitted: May 31, 2016
• First Submitted That Met QC Criteria: May 31, 2016
• First Posted (Estimate): June 3, 2016

Study Record Updates

• Last Update Posted (Actual): November 24, 2017
• Last Update Submitted That Met QC Criteria: November 21, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: IM018-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No