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

Phase 1

Completed

• Conditions: Healthy Participants
• Interventions: Drug: BMS-986278; Other: Placebo

• Registration Number: NCT03429933
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-02-05
• Study Start: 2018-02-07
• Study First Submitted QC: 2018-02-09
• Study First Posted: 2018-02-12
• Primary Completion: 2019-03-02
• Study Completion: 2019-03-02
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-27
• Last Update Posted: 2019-10-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 112

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)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Single Ascending Dose	Placebo	BMS-986278 or placebo
Multiple Ascending Dose	Placebo	BMS-986278 or placebo
Single Ascending Dose	BMS-986278	BMS-986278 or placebo
Multiple Ascending Dose	BMS-986278	BMS-986278 or placebo

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Local Institution; 🇬🇧 London, United Kingdom