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A Study to Determine the Safety, Drug Levels and Drug Effects of BMS-986196 and Food and Formulation Effects on Relative Absorption Healthy Participants - IM038-008

Actualizada: 6 mayo, 2021   |   ClinicalTrials.gov

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Detalles del estudio

  • Phase 1

    Fase

  • Géneros

  • 18-55

    Rango de edad

  • 1

    Ubicación (es)

  • Not Yet Recruiting

Opciones de tratamiento

Brazos del estudio
INTERVENCIÓN ASIGNADA
Experimental: Part A: SAD
Drug: BMS-986196 Other: Placebo
Experimental: Part B: MAD
Drug: BMS-986196 Other: Placebo
Experimental: Part C: FE/Formul.
Drug: BMS-986196

Criterios clave de elegibilidad

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit: www.BMSStudyConnect.com Inclusion Criteria: - Women not of childbearing potential and men, ages 18 or local age of majority to 55 years, inclusive - Healthy male and female non-Japanese participants without clinically significant deviation from normal in medical history, physical examination, electrocardiogram (ECG), and clinical laboratory determinations - Body mass index (BMI) of 18 to 32 kg/m2, inclusive, and total body weight ≥ 50 kg Exclusion Criteria: - Known or suspected autoimmune disorder, including but not limited to rheumatoid arthritis, fibromyalgia, systemic lupus erythematosus, polymyalgia rheumatica, giant cell arteritis, Behcet's disease, dermatomyositis, MS, moderate to severe asthma, any autoimmune vasculitis, autoimmune hepatitis, or any other active autoimmune disease for which a participant requires medical follow-up or medical treatment - Any history of known or suspected congenital or acquired immunodeficiency state or condition that would compromise the participant's immune status - Presence of any factors that would predispose the participant to develop infection - A history of bacterial or fungal meningitis within 1 year prior to screening - A history of intracranial or intraspinal bleeding - Known intracranial space-occupying mass, including meningioma Other protocol-defined inclusion/exclusion criteria apply

Recomendamos encarecidamente que se comunique con BMS para informar los efectos secundarios (eventos adversos)
Los efectos secundarios (eventos adversos) y otros eventos reportables se definen aquí
Informe de efectos secundarios (eventos adversos) o quejas sobre la calidad del producto: información médica

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¿Tiene alguna pregunta? El soporte en vivo está disponible 24/7 -
Llame 855-907-3286 o Envíenos un correo electrónico