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A Study of Experimental Medication BMS-986278 Given to Healthy Participants

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03429933
Recruitment Status : Completed
First Posted : February 12, 2018
Last Update Posted : October 1, 2019
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Study Description
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Brief Summary:
The purpose of this study is to investigate experimental medication BMS-986278 given to healthy participants.

Condition or disease Intervention/treatment Phase
Healthy Participants Drug: BMS-986278 Other: Placebo Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 112 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double-Blind, Placebo-Controlled, Randomized, Single and Multiple Ascending Dose Study (Including Food Effect, pH Effect, and Japanese Bridging Study) of the Safety, Pharmacokinetics, and Exploratory Pharmacodynamics of Oral BMS-986278 Administration in Healthy Participants
Actual Study Start Date : February 7, 2018
Actual Primary Completion Date : March 2, 2019
Actual Study Completion Date : March 2, 2019
Arms and Interventions
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Arm Intervention/treatment
Experimental: Single Ascending Dose
BMS-986278 or placebo
 Drug: BMS-986278
Specified dose on specified days

Other: Placebo
Specified dose on specified days
Experimental: Multiple Ascending Dose
BMS-986278 or placebo
 Drug: BMS-986278
Specified dose on specified days

Other: Placebo
Specified dose on specified days


Outcome Measures
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Primary Outcome Measures :
  1. Number of participants experiencing adverse events (AE), serious adverse events (SAE), death, or an AE leading to study discontinuation [ Time Frame: Up to 30 days ]
  2. Number of participants with potentially clinically significant changes in ECG parameters, vital signs, clinical laboratory parameters, or physical examinations [ Time Frame: Up to 30 days ]

Eligibility Criteria
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Ages Eligible for Study:   21 Years to 65 Years   (Adult, Older 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:

  • Participants must be in good general health in the opinion of the investigator
  • Body mass index (BMI) of 18.0 to 30.0 kg/m2, inclusive, at screening; BMI = weight (kg)/height (m)2
  • Body weight between 55 and 105 kg, inclusive, at screening
  • Female participants must have documented proof that they are not of childbearing potential
  • Participants in the Japanese cohorts must be first-generation Japanese (born in Japan, not living outside of Japan for more than 10 years, and both parents are ethnically Japanese)

Exclusion Criteria:

  • Women who are of childbearing potential or breastfeeding
  • Any significant acute or chronic medical condition that presents a potential risk to the participant and/or that may compromise the objectives of the study, including active, or history of, liver disease, or intestinal disorder including irritable bowel syndrome
  • History or presence of malignancy including hematological malignancies; participants with a history of basal cell or squamous cell carcinoma that has been treated with no evidence of recurrence within 5 years will be allowed for inclusion, as judged by the investigator
  • Current or recent (within 3 months of study drug administration) gastrointestinal disease that could impact upon the absorption of study drug
  • Any major surgery within 6 weeks of study drug administration

Other protocol defined inclusion/exclusion criteria could apply

Contacts and Locations
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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): NCT03429933


Locations
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Netherlands
Local Institution
Groningen, Netherlands, 9728 NZ
United Kingdom
Local Institution
London, United Kingdom, SE1 1YR
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
More Information
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Additional Information:

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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT03429933    
Other Study ID Numbers: IM027-009
2017-004136-10 ( EudraCT Number )
First Posted: February 12, 2018    Key Record Dates
Last Update Posted: October 1, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes