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A Study to Assess the Effect of Voriconazole and Quinidine on the Pharmacokinetics of a Single Dose of Repotrectinib in Healthy Participants - CA127-1072
Zaktualizowano: 8 lipiec, 2024 | ClinicalTrials.gov
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Inclusion Criteria - Healthy male and female individual(s) not of childbearing potential (INOCBP) participants of any race or ethnicity, as determined by no clinically significant findings in medical history, physical examination, 12-lead ECG, or vital signs as determined by the investigator or designee. - Potassium, magnesium, and calcium at or above the lower limit of normal. For other clinical laboratory parameters, no clinically significant findings as determined by the investigator or designee. - Must have a body mass index between 18 and 30 kg/m2 (inclusive) and body weight ≥ 50 kg at the time of signing the ICF. Exclusion Criteria - History of clinically significant acute or chronic medical illness, such as endocrine, gastrointestinal (GI), cardiovascular, peripheral vascular, hematological, hepatic, immunological, renal, respiratory, neoplastic, or genitourinary abnormalities/diseases as determined by the investigator or designee. - History of GI disease or surgery that could possibly affect drug absorption, distribution, metabolism, and excretion (ADME) (eg, bariatric procedure, cholecystectomy). Uncomplicated appendectomy and hernia repair are acceptable. - Gilbert's syndrome. - Other protocol-defined Inclusion/Exclusion criteria apply.
