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
Opdateret: 24 februar, 2025 | ClinicalTrials.gov
Fase
Køn
Aldersinterval
Beliggenhed(er)
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.
Hvis du vil rapportere en bivirkning, kan du indberette direkte til Lægemiddelstyrelsen via hjemmesiden www.meldenbivirkning.dk
Vi anbefaler at du også kontakter BMS for at rapportere bivirkninger.
Bivirkninger og andre rapporterbare begivenheder er defineret her
Rapporter bivirkninger eller klager over produktkvalitet: Medicinsk information
466-DK-2200001
