This is a Phase 1, single-center, nonrandomized, open-label, 2-part, fixed-sequence, drug-drug interaction (DDI) study to assess the effect of multiple doses of itraconazole, a CYP3A4 enzyme inhibitor, on the single dose PK of AZD4205 in healthy adult subjects (Part A) and to assess the effect of multiple doses of carbamazepine, a CYP3A4 inducer, on the single dose PK of AZD4205 in healthy adult subjects (Part B).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
32
All subjects will receive AZD4205 single dose on Day 1, and the second dose of AZD4205 along with carbamazepine after the wash-out period.
All subjects will receive AZD4205 single dose on Day 1, and the second dose of AZD4205 along with itraconazole after the wash-out period.
Pharmaceutical Research Associates, Inc.
Lenexa, Kansas, United States
Maximum plasma concentration (Cmax) of AZD4205 when dosed alone or coadministered with itraconazole (Part A)
Time frame: up to 10 days after study drug administration when AZD4205 dosed alone; up to 18 days after study drug administration when coadministered with itraconazole
Time to reach maximum plasma concentration (tmax) of AZD4205 when dosed alone or coadministered with itraconazole (Part A)
Time frame: up to 10 days after study drug administration when AZD4205 dosed alone; up to 18 days after study drug administration when coadministered with itraconazole
Area under the concentration-time curve from time 0 to time of last quantifiable concentration (AUC0-t) when dosed alone or coadministered with itraconazole (Part A)
Time frame: up to 10 days after study drug administration when AZD4205 dosed alone; up to 18 days after study drug administration when coadministered with itraconazole
Area under the concentration-time curve from time 0 to infinity (AUC0-inf) when dosed alone or coadministered with itraconazole (Part A)
Time frame: up to 10 days after study drug administration when AZD4205 dosed alone; up to 18 days after study drug administration when coadministered with itraconazole
Maximum plasma concentration (Cmax) of AZD4205 when dosed alone or coadministered with carbamazepine (Part B)
Time frame: up to 10 days after study drug administration
Time to reach maximum plasma concentration (tmax) of AZD4205 when dosed alone or coadministered with carbamazepine (Part B)
Time frame: up to 10 days after study drug administration
Area under the concentration-time curve from time 0 to time of last quantifiable concentration (AUC0-t) when dosed alone or coadministered with carbamazepine (Part B)
Time frame: up to 10 days after study drug administration
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Area under the concentration-time curve from time 0 to infinity (AUC0-inf) when dosed alone or coadministered with carbamazepine (Part B)
Time frame: up to 10 days after study drug administration