Recruiting
A Study to Evaluate the Bioequivalence Between Immediate Release Tablets and Minitablets of Deucravacitinib (BMS-986165), and the Effect of Food and pH on the Drug Levels of the Minitablets in Healthy Adults - IM011-1178
Actualizado: 24 febrero, 2025 | ClinicalTrials.gov
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Recruiting
Inclusion Criteria - Participants must be healthy as determined by no clinically significant deviation from normal in medical history, physical examination, vital signs, 12-lead ECGs, and clinical laboratory determinations in the opinion of the investigator. - Participants must be willing and able to complete all study-specific procedures and visits. - Participants must have a body mass index of 18.0 kg/m2 through 32.0 kg/m2, inclusive, and total body weight ≥ 50 kg (110 lb). Exclusion Criteria - Participants must not have any significant acute or chronic medical illness that presents a potential risk to the participant and/or may compromise the objectives of the study, including a history of/or acute liver disease in the opinion of the Investigator. - Participants must not have evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, 12-lead ECG, or clinical laboratory determinations beyond what is consistent with the population reference ranges in the opinion of the investigator. - Participants must not have any history of severe reaction to a drug (eg, anaphylactic, anaphylactoid, Stevens-Johnson, angioedematous), or adverse or allergic/hypersensitivity reaction to multiple drugs. - Other protocol-defined Inclusion/Exclusion criteria apply.
Recomendamos encarecidamente que se comunique con BMS para informar de 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
