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A Study to Evaluate the Safety, Tolerability, and Drug Levels of BMS-986337 When Taken by Mouth by Healthy Participants - IM037-009

Actualizada: 11 septiembre, 2020   |   ClinicalTrials.gov

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Detalles del estudio

  • Phase 1

    Fase

  • Géneros

  • 21-65

    Rango de edad

  • 1

    Ubicación (es)

  • Not Yet Recruiting

Opciones de tratamiento

Brazos del estudio
INTERVENCIÓN ASIGNADA
Experimental: Part A SAD Cohort A2
Other: BMS-986337 Placebo Drug: BMS-986337
Experimental: Part A SAD Cohort A3
Other: BMS-986337 Placebo Drug: BMS-986337
Experimental: Part A SAD Cohort A4
Other: BMS-986337 Placebo Drug: BMS-986337
Experimental: Part A SAD Cohort A5
Other: BMS-986337 Placebo Drug: BMS-986337
Experimental: Part A SAD Cohort A6
Biological: Famotidine Drug: BMS-986337
Experimental: Part A Single Ascending Dose (SAD) Cohort A1
Other: BMS-986337 Placebo Drug: BMS-986337
Experimental: Part B MAD Cohort B2
Other: BMS-986337 Placebo Drug: BMS-986337
Experimental: Part B MAD Cohort B3
Other: BMS-986337 Placebo Drug: BMS-986337
Experimental: Part B MAD Cohort B4
Other: BMS-986337 Placebo Drug: BMS-986337
Experimental: Part B Multiple Ascending Dose (MAD) Cohort B1
Drug: BMS-986337 Other: BMS-986337 Placebo
Experimental: Part C MAD in Japanese Healthy participants Cohort C1
Other: BMS-986337 Placebo Drug: BMS-986337
Experimental: Part C MAD in Japanese Healthy participants Cohort C2
Other: BMS-986337 Placebo Drug: BMS-986337
Experimental: Part C MAD in Japanese Healthy participants Cohort C3
Other: BMS-986337 Placebo Drug: BMS-986337

Criterios clave de elegibilidad

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com. Inclusion Criteria: - No clinically significant deviation from normal in medical history, physical examination, electrocardiograms (ECGs), and clinical laboratory determinations - For 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) - Body mass index (BMI) of 18.0 kg/m^2 to 30.0 kg/m^2, inclusive, at screening; BMI = weight (kg)/height (m)^2 - Women and men must agree to follow specific methods of contraception, if applicable Exclusion Criteria: - Women who are of childbearing potential - Women who are breastfeeding - Prior exposure to BMS-986278 - Positive nasopharyngeal reverse transcriptase polymerase chain reaction (RT-PCR) test for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) on Day -2 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