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

NCT03429933 — Phase 1, Completed, 112 participants, Bristol-Myers Squibb

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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

Registry	NCT03429933
Status	Completed
Phase	Phase 1
Study type	Interventional; randomized, parallel, masking: quadruple, treatment
Enrollment	112 (Actual)
Sponsor	Bristol-Myers Squibb (Industry)
Conditions	Healthy Participants
Interventions	BMS-986278, Placebo (Drug, other)
Dates	start 2018-02-07, primary completion 2019-03-02, completion 2019-03-02, first posted 2018-02-12, last updated 2019-10-01
Locations	2 sites in Netherlands, United Kingdom

-Summary

The purpose of this study is to investigate experimental medication BMS-986278 given to healthy participants.

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+Arms and interventions

Arm	Type	Interventions	Description
Single Ascending Dose	Experimental	Drug: BMS-986278; Other: Placebo	BMS-986278 or placebo
Multiple Ascending Dose	Experimental	Drug: BMS-986278; Other: Placebo	BMS-986278 or placebo

BMS-986278 (Drug): Specified dose on specified days
Placebo (Other): Specified dose on specified days

+Outcome measures

Primary outcomes

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

+Eligibility

Sex: All, ages: 21 Years to 65 Years, accepts healthy volunteers

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

+Locations (2)

Facility	City	Country	Status
Local Institution	Groningen	Netherlands
Local Institution	London	United Kingdom

+Investigators

Bristol-Myers Squibb, Study director, Bristol-Myers Squibb

+Funding

NIH grants: 2017

My Notes

Public

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