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

Table 1 Patient demographic and baseline clinical characteristics

Parameter^a	P-gp inhibitor study (N = 14)	CYP3A inhibitors study		CYP3A inducer study (N = 14)
Parameter^a	P-gp inhibitor study (N = 14)	Itraconazole cohort (n = 14)	Fluconazole cohort (n = 14)	CYP3A inducer study (N = 14)
Sex, n (%)
Male	14 (100)	10 (71.4)	10 (71.4)	12 (85.7)
Female	0	4 (28.6)	4 (28.6)	2 (14.3)
Age, years	34.4 (7.1)	27.7 (4.2)	27.5 (4.4)	40.6 (7.9)
Weight, kg	81.77 (11.16)	61.49 (9.43)	59.77 (6.57)	79.77 (9.61)
BMI, kg/m²	26.18 (2.34)	22.07 (1.83)	20.70 (1.42)	26.75 (2.28)
Race, n (%)
White	10 (71.4)	0	0	5 (35.7)
Black/African American	4 (28.6)	0	0	8 (57.1)
Asian	0	14 (100)	14 (100)	0
Multiple	0	0	0	1 (7.1)
Ethnicity, n (%)
Hispanic or Latino	3 (21.4)	NA	NA	7 (50.0)
Not Hispanic or Latino	11 (78.6)	NA	NA	7 (50.0)
ALT, IU/L	24.9 (15.3)	15.2 (5.2)	15.8 (8.1)	21.2 (8.7)
AST, IU/L	21.6 (5.9)	15.6 (3.1)	17.2 (3.5)	20.9 (3.7)
Creatinine, µmol/L	85.2 (12.8)	67.2 (13.3)	68.1 (10.6)	82.7 (11.8)

ALT alanine aminotransferase, AST aspartate aminotransferase, BMI body mass index, NA not applicable, SD standard deviation
^aValues are mean (SD) unless otherwise specified