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

Healthy Participants Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03429933
• Other study ID #: IM027-009
• Secondary ID: 2017-004136-10
• Status: Completed
• Phase: Phase 1
• Start date: February 7, 2018
• Est. completion date: March 2, 2019

Study information

• Verified date: September 2019
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 112
• Est. completion date: March 2, 2019
• Est. primary completion date: March 2, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Participants

Intervention

Drug:
• BMS-986278
Specified dose on specified days

Other:
• Placebo
Specified dose on specified days

Locations

Country	Name	City	State
Netherlands	Local Institution	Groningen
United Kingdom	Local Institution	London

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

Netherlands,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants experiencing adverse events (AE), serious adverse events (SAE), death, or an AE leading to study discontinuation		Up to 30 days
Primary	Number of participants with potentially clinically significant changes in ECG parameters, vital signs, clinical laboratory parameters, or physical examinations		Up to 30 days

External Links

•   BMS Clinical Trial Information
•   BMS Clinical Trial Patient Recruiting
•   FDA Safety Alerts and Recalls
•   Investigator Inquiry Form