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

NCT02790125 | Completed Phase 1 FDA Drug

• 1 other identifier: IM018-001
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (11)

• 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 Outcomes (10)

• 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

Study Arms (5)

Dose Panel 1

EXPERIMENTAL

BMS-986166 or Placebo matching BMS-986166 Single oral dose of solution as specified

Drug: BMS-986166; Drug: Placebo matching BMS-986166

Dose Panel 2

EXPERIMENTAL

BMS-986166 or Placebo matching BMS-986166 Single oral dose of solution as specified

Drug: BMS-986166; Drug: Placebo matching BMS-986166

Dose Panel 3

EXPERIMENTAL

BMS-986166 or Placebo matching BMS-986166 Single oral dose of solution as specified

Drug: BMS-986166; Drug: Placebo matching BMS-986166

Dose Panel 4

EXPERIMENTAL

BMS-986166 or Placebo matching BMS-986166 Multiple ascending solid dose formulation as specified

Drug: BMS-986166; Drug: Placebo matching BMS-986166

Dose Panel 5a/b/c

EXPERIMENTAL

BMS-986166 Single oral solid dose formulation under fasting/fed/fasting with famotidine conditions

Drug: BMS-986166

Interventions

BMS-986166 DRUG

Dose Panel 1; Dose Panel 2; Dose Panel 3; Dose Panel 4; Dose Panel 5a/b/c

Placebo matching BMS-986166 DRUG

Dose Panel 1; Dose Panel 2; Dose Panel 3; Dose Panel 4

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (1)

PPD Development, LLC

Austin, Texas, 78744, United States

Location

Related Publications (1)

• 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.

  PMID: 32306792 DERIVED

Related Links

• BMS Clinical Trial Patient Recruiting
• Investigator Inquiry Form

MeSH Terms

Interventions

BMS-986166

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 31, 2016
• First Posted: June 3, 2016
• Study Start: July 28, 2016
• Primary Completion: November 7, 2017
• Study Completion: November 7, 2017
• Last Updated: November 24, 2017

Record last verified: 2017-11

Locations

US (1)