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

• Sponsor: Bristol-Myers Squibb (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03429933
• Collaborator: (none)
• Enrollment: 112
• Locations: 2
• Arms: 2
• Actual Duration (Months): 12.7
• Patients Per Site: 56
• Patients Per Site Per Month: 4.4

Study Details

Study Description

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

• Study Type: Interventional
• 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: Feb 7, 2018
• Actual Primary Completion Date: Mar 2, 2019
• Actual Study Completion Date: Mar 2, 2019

Arms and Interventions

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

Primary Outcome Measures

1. Number of participants experiencing adverse events (AE), serious adverse events (SAE), death, or an AE leading to study discontinuation [Up to 30 days]

2. Number of participants with potentially clinically significant changes in ECG parameters, vital signs, clinical laboratory parameters, or physical examinations [Up to 30 days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	Local Institution	Groningen		Netherlands	9728 NZ
2	Local Institution	London		United Kingdom	SE1 1YR

Sponsors and Collaborators

• Bristol-Myers Squibb

Investigators

• Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

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

Publications

None provided.

• Responsible Party: Bristol-Myers Squibb
• ClinicalTrials.gov Identifier: NCT03429933
• Other Study ID Numbers: IM027-009; 2017-004136-10
• First Posted: Feb 12, 2018
• Last Update Posted: Oct 1, 2019
• Last Verified: Sep 1, 2019

• 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

Study Results

No Results Posted as of Oct 1, 2019