The purpose of the study is to assess the pharmacokinetics (PK) of AZD4144 when administered alone and in combination with itraconazole in healthy participants.
This is an open-label, randomised, two arm, 3 period, fixed sequence study in healthy participants. The study will include two parallel, independent arms with one arm evaluating oral administration of AZD4144 and the other evaluating AZD4144 administered as an intravenous (IV) infusion. Each study arm will comprise of: 1. A screening period of up to 28 days. 2. Three treatment periods during which participants will receive AZD4144 alone, itraconazole alone, and AZD4144 in combination with itraconazole. 3. A final follow-up visit.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
32
AZD4144 will be administered orally.
AZD4144 will be administered as an IV infusion.
Itraconazole will be administered orally.
Research Site
Harrow, United Kingdom
RECRUITINGArea under concentration time curve from time 0 to infinity (AUCinf)
To assess the effect of itraconazole on the PK (AUCinf) of AZD4144
Time frame: Period 1: Day 1 to Day 6; Period 3: Day 10 to Day 16
Area under concentration curve from time 0 to the last quantifiable concentration (AUClast)
To assess the effect of itraconazole on the PK (AUClast) of AZD4144
Time frame: Period 1: Day 1 to Day 6; Period 3: Day 10 to Day 16
Maximum observed drug concentration (Cmax)
To assess the effect of itraconazole on the PK (Cmax) of AZD4144
Time frame: Period 1: Day 1 to Day 6; Period 3: Day 10 to Day 16
Total body clearance (CL)
To describe the PK (CL) of AZD4144 when administered alone, and in combination with itraconazole
Time frame: Period 1: Day 1 to Day 6; Period 3: Day 10 to Day 16
Apparent total body clearance (CL/F)
To describe the PK (CL/F) of AZD4144 when administered alone, and in combination with itraconazole
Time frame: Period 1: Day 1 to Day 6; Period 3: Day 10 to Day 16
Volume of distribution during the terminal phase (Vz)
To describe the PK (Vz) of AZD4144 when administered alone, and in combination with itraconazole
Time frame: Period 1: Day 1 to Day 6; Period 3: Day 10 to Day 16
Apparent volume of distribution based on the terminal phase (Vz/F)
To describe the PK (Vz/F) of AZD4144 when administered alone, and in combination with itraconazole
AstraZeneca Clinical Study Information Center
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Time frame: Period 1: Day 1 to Day 6; Period 3: Day 10 to Day 16
Terminal elimination half life (t½λz)
To describe the PK (t½λz) of AZD4144 when administered alone, and in combination with itraconazole
Time frame: Period 1: Day 1 to Day 6; Period 3: Day 10 to Day 16
Time to reach maximum observed concentration (tmax)
To describe the PK (tmax) of AZD4144 when administered alone, and in combination with itraconazole
Time frame: Period 1: Day 1 to Day 6; Period 3: Day 10 to Day 16