A Study of Experimental Medication BMS-986235 in Healthy Subjects

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 1

Conditions: Mediators of Inflammation

Treatments: Drug: BMS-986235; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03335553

CV018-001

Details and patient eligibility

About

This is a study of experimental medication BMS-986235 in healthy subjects.

Enrollment: 122 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Patients must be normal healthy volunteers as determined by no clinically significant deviations in medical history, physical examination, ECGs, vital signs, and clinical laboratory determinations
• Patients must have a body mass index (BMI) of 18 - 30 mg/kg2, inclusive

Exclusion criteria

• Patients that are pregnant
• Patient with any significant acute or chronic medical illness
• Patient with a current or recent (within 3 months of study treatment administration) gastrointestinal disease that could affect absorption
• Patient with any surgery within 12 weeks of study treatment administration
• Patient with any gastrointestinal surgery that could impact upon the absorption of study drug
• Patient who donated blood to a blood bank or in a clinical study (except a screening visit) within 12 weeks of study drug administration (within 2 weeks for plasma only)
• Patient who received a blood transfusion within 12 weeks of study drug administration

Other protocol defined inclusion/exclusion criteria apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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122 participants in 2 patient groups

Single ascending dose (SAD): BMS-986235 or Placebo

Experimental group

Description:

BMS-986235 or Placebo oral dose

Treatment:

Other: Placebo

Drug: BMS-986235

Multiple ascending dose (MAD): BMS-986235 or Placebo

Experimental group

Description:

BMS-986235 or Placebo oral dose

Treatment:

Other: Placebo

Drug: BMS-986235