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A Study to Evaluate the Safety, Tolerability, and Drug Levels of BMS-986521 in Healthy Participants. - CN014-0001
Updated: 2 prosinec, 2025 | ClinicalTrials.gov
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Inclusion Criteria: - Participants must be healthy males and females (assigned at birth) who are not of childbearing potential, with no clinically significant abnormalities in medical history, physical exam, ECG, or lab tests. - Participants must have a body mass index (BMI) between 18 and 32 kg/m² (inclusive) and body weight of at least 50 kg. - For Part B/Cohort 11 only: participants with stable cardiovascular conditions may be included if deemed suitable by the investigator. Exclusion Criteria: - Participants must not have any significant medical condition or history (renal, hepatic, hematologic, GI, endocrine, pulmonary, neurologic, or immunologic) that may affect drug absorption, distribution, metabolism, or excretion (ADME), or pose a risk to the participant. - Participants must not have a history of rhabdomyolysis, cancer (except certain cured skin or cervical cancers), hematologic malignancy, or myelodysplastic syndrome. - Participants must not have recent or current significant GI disease, major surgery, or medical interventions affecting ADME (except appendectomy or cholecystectomy). - Participants must not have had a blood transfusion within 4 weeks or have an inability to tolerate oral medication or venous access. - Other protocol defined inclusion/exclusion criteria apply.
Důrazně doporučujeme kontaktovat BMS a oznámit vedlejší účinky / nežádoucí příhody
Zde jsou definovány vedlejší účinky / nežádoucí příhody a další příhody, které by měly být hlášeny
Nahlásit vedlejší účinky / nežádoucí příhody nebo stížnosti na kvalitu produktu: lékařské informace
