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Not Yet Recruiting

Safety, Tolerability, Kinetics, and Repeatability of the Novel LPA1 PET Ligand 18F-BMS-986327 - IM033-002

Actualizada: 27 September, 2019   |   ClinicalTrials.gov

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Detalles del estudio

  • Phase 1

    Fase

  • Géneros

  • 18+

    Rango de edad

  • 1

    Ubicación (es)

  • Not Yet Recruiting

Opciones de tratamiento

Brazos del estudio
INTERVENCIÓN ASIGNADA
Experimental: Part 1:18F-BMS-986327 (Safety Study)
Diagnostic Test: 18F-BMS-986327
Experimental: Part 2: 18F-BMS-986327 (Test/Retest Study)
Diagnostic Test: 18F-BMS-986327
Experimental: Part 3: 18F-BMS-986327 (Distribution in Partcipants with IPF)
Diagnostic Test: 18F-BMS-986327

Criterios clave de elegibilidad

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: - Body weight at least 50kg (110lbs), Body Mass Index (BMI) within 19 to 32 kg/m^2, inclusive - Must be in good health as determined by medical history, physical examination, ECG, serum/urine biochemistry, hematology, and serology tests - Negative hepatitis panel and negative human immunodeficiency virus (HIV)antibody screens - Women of childbearing potential (WOCBP) and men who are sexually active with WOCBP must use acceptable method(s) of contraception. The individual methods of contraception and duration should be determined in consultation with the investigator. WOCBP must follow instructions for birth control when the half-life of the investigational drug is less than 24 hours, contraception should be continued for a period of 30 days after the last dose of investigational product. - Women must have a negative urine pregnancy test within 24 hours prior to the start of investigational product. - Women must not be breastfeeding. - Men who are sexually active with WOCBP must use any contraceptive method with a failure rate of less than 1% per year. Men that are sexually active with WOCBP must follow instructions for birth control when the half-life of the investigational drug is less than 24 hours, contraception should be continued for a period of 90 days after the last dose of investigational product. - Women who are not of childbearing potential (i.e., who are postmenopausal or surgically sterile) and azoospermic men do not require contraception. Exclusion Criteria: - Any history or presence of clinically significant respiratory, Gastro Intestinal (GI), renal, hepatic, pancreatic, hematological, neurological (including history of seizure), cardiovascular, psychiatric (including known addictive disorders), musculoskeletal, genitourinary, immunological, or dermatological disorders, including all cancers - Any acute or chronic condition that, in the opinion of the investigator in consultation with the BMS Medical Monitor, could jeopardize the subject's safety, tolerability, or pharmacokinetics of 18F-BMS-986327." - Any major surgery within 4 weeks of study drug administration - Existence of a cold, upper respiratory tract infection, or fever within 5 days prior to check-in - Presence or history of any abnormality or illness that may affect absorption, distribution, metabolism or elimination of the study drug - Donation of blood or plasma (exclude the screening visit) within 2 months prior to check in through end of synthesis (EOS), inclusive

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