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Active, Not Recruiting

An Ascending Dose Study of BMS-986259 to Study Safety in Healthy Participants - CV019-002

Actualizada: 8 abril, 2020   |   ClinicalTrials.gov

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Detalles del estudio

  • Phase 1

    Fase

  • Géneros

  • 18-55

    Rango de edad

  • Active, Not Recruiting

Opciones de tratamiento

Brazos del estudio
INTERVENCIÓN ASIGNADA
Experimental: Part A SAD
Diagnostic Test: P-Aminohippurate Other: Placebo Drug: BMS-986259 Diagnostic Test: Iohexol
Experimental: Part A SAD - A5 Cohort
Diagnostic Test: P-Aminohippurate Other: Placebo Drug: BMS-986259 Diagnostic Test: Iohexol
Experimental: Part A SAD- A4 Cohort
Diagnostic Test: P-Aminohippurate Other: Placebo Drug: BMS-986259 Diagnostic Test: Iohexol
Experimental: Part A SAD- A6 Cohort
Diagnostic Test: P-Aminohippurate Other: Placebo Drug: BMS-986259 Diagnostic Test: Iohexol
Experimental: Part B MAD
Diagnostic Test: Iohexol Diagnostic Test: P-Aminohippurate Other: Placebo Drug: BMS-986259
Experimental: Part B MAD - B2 Cohort
Diagnostic Test: P-Aminohippurate Other: Placebo Drug: BMS-986259 Diagnostic Test: Iohexol
Experimental: Part B MAD - B3 Cohort
Diagnostic Test: P-Aminohippurate Other: Placebo Diagnostic Test: Iohexol Drug: BMS-986259
Experimental: Part B MAD - B4 Cohort
Diagnostic Test: P-Aminohippurate Other: Placebo Drug: BMS-986259 Diagnostic Test: Iohexol
Experimental: Part B MAD- B1 Cohort
Diagnostic Test: P-Aminohippurate Other: Placebo Drug: BMS-986259 Diagnostic Test: Iohexol
Experimental: Part C JMAD
Diagnostic Test: Iohexol Diagnostic Test: P-Aminohippurate Other: Placebo Drug: BMS-986259
Experimental: Part C JMAD - C1 Cohort
Other: Placebo Drug: BMS-986259 Diagnostic Test: Iohexol Diagnostic Test: P-Aminohippurate
Experimental: Part C JMAD - C2 Cohort
Other: Placebo Drug: BMS-986259 Diagnostic Test: Iohexol Diagnostic Test: P-Aminohippurate
Experimental: Part C JMAD - C3 Cohort
Other: Placebo Drug: BMS-986259 Diagnostic Test: Iohexol Diagnostic Test: P-Aminohippurate

Criterios clave de elegibilidad

Inclusion Criteria: - Healthy participants with a body mass Index (BMI) of 18.0 kg/m^2 - 30.0 kg/m^2. - Males and females not of child bearing potential. - Participants in the Japanese Cohorts in Part C 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: - Any previous dosing in another cohort in the current study or participation in an investigational drug within 2 months prior to (the first) drug administration in the current study. - Any Significant Acute or Chronic medical Illness, major surgery in 12 months, or so smoking or used smoking cessation in 3 months. - Inability to be venipunctured and/or tolerate venous access. ,abnormalities in hemoglobin or positive screen for hepatitis C, Hepatitis B, Human Immunodeficiency Virus (HIV), including hepatic disease

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