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Completed

NCT Number: NCT03038711

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

The purpose of this study is to understand if multiple oral doses of BMS-986166 are safe and well tolerated in healthy patients.

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Key information

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 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

Treatment and study plan

BMS-986166

Drug

Specified dose on specified days

Placebo matching BMS-986166

Other

Specified dose on specified days

Primary outcomes

  1. Incidence of All Adverse Events (AEs)

    Time frame: 77 days

    measured by number of patients

  2. Incidence of Serious Adverse Events (SAEs)

    Time frame: 77 days

    measured by number of patients

  3. Severity of all Adverse Events (AEs)

    Time frame: 77 days

    measured by investigator

  4. Change from baseline in physical examination findings

    Time frame: 77 days

    measured by investigator

  5. Change from baseline in electrocardiogram (ECG) results

    Time frame: 77 days

    measured by ECG

  6. Change from baseline in continuous cardiac monitoring data

    Time frame: 15 days

    measured with external monitoring device

  7. Change from baseline in clinical laboratory test results

    Time frame: 77 days

    measured by serum chemistry, hematology, serology and urinalysis results

  8. Change from baseline in body temperature

    Time frame: 77 days

    measured in degrees Celsius or Fahrenheit

  9. Change from baseline in respiratory rate

    Time frame: 77 days

    measured by investigator

  10. Change from baseline in seated blood pressure

    Time frame: 77 days

    measured by investigator

  11. Change from baseline in heart rate

    Time frame: 77 days

    measured by investigator

Secondary outcomes

  1. Mean heart rate (HR)

    Time frame: 15 days

    Calculated from nadir HR to time-matched HR on Day -1

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

    Time frame: 15 days

    measured by investigator

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

    Time frame: 15 days

    measured by investigator

  4. Time to largest decrease HR from time 0 hour (predose)

    Time frame: 15 days

    measured by investigator

  5. 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

    measured by investigator

  6. Largest percent decrease in absolute lymphocyte count (ALC) from time-matched Day -1 baseline

    Time frame: 35 days

    measured by ALC

  7. Time to largest percent reduction ALC from time 0 hour (predose)

    Time frame: 35 days

    measured by ALC

  8. 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

    measured by ALC

  9. Maximum observed blood concentration (Cmax)

    Time frame: 77 days

    measured by blood concentration versus time data

  10. Time of maximum observed blood concentration (Tmax)

    Time frame: 77 days

    measured by blood concentration versus time data

  11. Terminal half-life (T-HALF)

    Time frame: 77 days

    measured by blood concentration versus time data

  12. Area under the blood concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T))

    Time frame: 77 days

    measured by blood concentration versus time data

  13. Area under the blood concentration-time curve from time zero extrapolated to infinite time (AUC(INF))

    Time frame: 77 days

    measured by blood concentration versus time data

  14. Apparent total clearance (CLT/F)

    Time frame: 77 days

    measured by blood concentration versus time data

  15. Apparent steady state volume (Vz/F)

    Time frame: 77 days

    measured by blood concentration versus time data

  16. Area under the concentration-time curve from time zero extrapolated to infinite time [AUC(INF)]

    Time frame: 77 days

    Used to calculate metabolite to parent molar ratio of pharmacokinetic parameter

  17. Area under the concentration-time curve from time zero to the time of the last quantifiable concentration [AUC(0-T)]

    Time frame: 77 days

    Used to calculate metabolite to parent molar ratio of pharmacokinetic parameter

  18. Maximum observed concentration (Cmax)

    Time frame: 77 days

    Used to calculate metabolite to parent molar ratio of pharmacokinetic parameter

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Feb 1, 2017
Registry last updated
Jan 30, 2019

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.

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