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Table 1 Patient demographic and baseline clinical characteristics

From: Clinical Drug-Drug Interaction Studies to Evaluate the Effects of a P-Glycoprotein Inhibitor, CYP3A Inhibitors, and a CYP3A Inducer on the Pharmacokinetics of Naldemedine in Healthy Subjects

ParameteraP-gp inhibitor study (N = 14)CYP3A inhibitors studyCYP3A inducer study (N = 14)
Itraconazole cohort (n = 14)Fluconazole cohort (n = 14)
Sex, n (%)    
 Male14 (100)10 (71.4)10 (71.4)12 (85.7)
 Female04 (28.6)4 (28.6)2 (14.3)
Age, years34.4 (7.1)27.7 (4.2)27.5 (4.4)40.6 (7.9)
Weight, kg81.77 (11.16)61.49 (9.43)59.77 (6.57)79.77 (9.61)
BMI, kg/m226.18 (2.34)22.07 (1.83)20.70 (1.42)26.75 (2.28)
Race, n (%)    
 White10 (71.4)005 (35.7)
 Black/African American4 (28.6)008 (57.1)
 Asian014 (100)14 (100)0
 Multiple0001 (7.1)
Ethnicity, n (%)    
 Hispanic or Latino3 (21.4)NANA7 (50.0)
 Not Hispanic or Latino11 (78.6)NANA7 (50.0)
ALT, IU/L24.9 (15.3)15.2 (5.2)15.8 (8.1)21.2 (8.7)
AST, IU/L21.6 (5.9)15.6 (3.1)17.2 (3.5)20.9 (3.7)
Creatinine, µmol/L85.2 (12.8)67.2 (13.3)68.1 (10.6)82.7 (11.8)
  1. ALT alanine aminotransferase, AST aspartate aminotransferase, BMI body mass index, NA not applicable, SD standard deviation
  2. aValues are mean (SD) unless otherwise specified