This study will investigate the effect of multiple doses of the strong P450 enzyme inhibitor itraconazole on the pharmacokinetics of Lu AF35700 in healthy subjects.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
22
Tablets for oral use, single dose in a fasted state. EMs: 10 mg/day, PMs: 5 mg
100 mg Capsules for oral use, 200 mg/day. In a fed state
100mg Capsules for oral use, 300 mg/day. In a fasted state.
Covance - Dallas
Dallas, Texas, United States
Covance Clinical Research Unit Ltd
Leeds, United Kingdom
AUC(0-inf)
Area under the Lu AF35700 plasma concentration-time curve (with and without itraconazole) for CYP2D6 EMs
Time frame: Day 1: Predose to day 29 postdose, Day 32: Predose to day 74 postdose
Cmax
Maximum observed plasma concentration of Lu AF35700 (with and without itraconazole) for CYP2D6 EMs
Time frame: 0-24 hours postdose (Day 1 and day 32)
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