A Study to Assess Drug Levels, Tolerability and Absolute Biological Availability of Single-dose of BMS-986446 in Healthy Participants

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteer

Treatments: Drug: BMS-986446 IV; Drug: Loratadine; Drug: BMS-986446 SC; Drug: Acetaminophen

Study type: Interventional

Funder types: Industry

Identifiers

NCT06955741

CN008-0026

Details and patient eligibility

About

The purpose of this study is to assess drug levels, tolerability and absolute biological availability of single subcutaneous dose of BMS-986446 in healthy participants

Enrollment: 46 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Participants must have a Body Mass Index (BMI) of 18.0 to 30.0 kg/m2.
• Participants must be healthy as determined by medical history, physical examination, neurological examination, vital signs, 12-lead ECG, C-SSRS, and clinical laboratory evaluations.

Exclusion criteria

• Participants must not have clinically significant gastrointestinal, renal, hepatic, broncho-pulmonary, neurological, psychiatric, cardiovascular, endocrinological, immune-mediated disorder, hematological, ongoing allergic disorder requiring treatment, metabolic disorder, cancer, or cirrhosis.
• Participants must not have prior exposure to BMS-986446 (PRX005).
• Other protocol-defined Inclusion/Exclusion criteria apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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46 participants in 2 patient groups

Arm A

Experimental group

Treatment:

Drug: Acetaminophen

Drug: Loratadine

Drug: BMS-986446 IV

Arm B

Experimental group

Treatment:

Drug: Acetaminophen

Drug: BMS-986446 SC

Drug: Loratadine