Skip to main content
OpenTrials
Completed

NCT Number: 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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Healthy

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

PPD Development, LLC

Austin, Texas, 78744, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BMS-986166

Drug

Placebo matching BMS-986166

Drug

Primary outcomes

  1. Incidence of All Adverse Events (AEs)

    Time frame: Baseline Day -1 to Day 65

  2. Incidence of Serious Adverse Events (SAEs)

    Time frame: Baseline Day -1 to Day 65

  3. Severity of all All Adverse Events (AEs)

    Time frame: Baseline Day -1 to Day 65

  4. Change from baseline in electrocardiogram(ECG) results

    Time frame: Baseline Day -1 to Day 35

  5. Change from baseline in body temperature

    Time frame: Baseline Day -1 to Day 35

  6. Change from baseline in respiratory rate

    Time frame: Baseline Day -1 to Day 35

  7. Change from baseline in seated blood pressure

    Time frame: Baseline Day -1 to Day 35

  8. Change from baseline in heart rate

    Time frame: Baseline Day -1 to Day 35

  9. Change from baseline in clinical laboratory test results

    Time frame: Baseline Day -1 to Day 35

    Clinical laboratory testing to include Chemistry analytes and Hematology analytes.

  10. Change from baseline in continuous cardiac monitoring data

    Time frame: Baseline Day -1 to Day 35

  11. Change from baseline in physical examination findings

    Time frame: Baseline Day -1 to Day 35

Secondary outcomes

  1. Mean difference in nadir heart rate (HR) and its time-matched HR on Day -1

    Time frame: Day -1 to Day 4

  2. Largest decrease in HR from time-matched Day -1 baseline

    Time frame: Day -1 to Day 4

  3. Time to nadir HR from time 0 hour (predose)

    Time frame: Day -1 to Day 4

  4. Percent reduction in HR at nadir from time-matched Day -1 HR value

    Time frame: Day -1 to Day 4

  5. 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

    Time frame: Day -1 to Day 7

  6. Mean difference in absolute lymphocyte count (ALC) values and its time-matched ALC on Day -1 in BMS-986166- treated versus placebo-treated subjects

    Time frame: Day -1 to Day 4

  7. Largest decrease in ALC from time-matched Day -1 baseline

    Time frame: Day -1 to Day 4

  8. Time to nadir ALC from time 0 hour (predose)

    Time frame: Day -1 to Day 4

  9. Percent reduction in ALC at nadir from time-matched Day -1 value

    Time frame: Day -1 to Day 4

  10. 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

    Time frame: Day -1 to Day 7

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jun 3, 2016
Registry last updated
Nov 24, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.