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

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ClinicalTrials.gov Identifier: NCT02790125
Recruitment Status : Completed
First Posted : June 3, 2016
Last Update Posted : November 24, 2017
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

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.

Condition or disease Intervention/treatment Phase
Healthy Drug: BMS-986166 Drug: Placebo matching BMS-986166 Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Screening
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
Actual Study Start Date : July 28, 2016
Actual Primary Completion Date : November 7, 2017
Actual Study Completion Date : November 7, 2017

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



Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02790125


Locations
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United States, Texas
PPD Development, LLC
Austin, Texas, United States, 78744
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

Additional Information:
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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT02790125     History of Changes
Other Study ID Numbers: IM018-001
First Posted: June 3, 2016    Key Record Dates
Last Update Posted: November 24, 2017
Last Verified: November 2017

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No