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

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 1

Conditions: Healthy Participants

Treatments: Other: Placebo; Drug: BMS-986278

Study type: Interventional

Funder types: Industry

Identifiers

NCT03429933

2017-004136-10 (EudraCT Number)

IM027-009

Details and patient eligibility

About

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

Enrollment: 112 patients

Sex: All

Ages: 21 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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112 participants in 2 patient groups

Single Ascending Dose

Experimental group

Description:

BMS-986278 or placebo

Treatment:

Drug: BMS-986278

Other: Placebo

Multiple Ascending Dose

Experimental group

Description:

BMS-986278 or placebo

Treatment:

Drug: BMS-986278

Other: Placebo