Investigating the Effect of Itraconazole on the Pharmacokinetics of AZD4144 in Healthy Participants
ConditionHealthy
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-55
SponsorAstraZeneca
About this trial
The purpose of the study is to assess the pharmacokinetics (PK) of AZD4144 when administered alone and in combination with itraconazole in healthy participants.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Healthy male and/or female participants with suitable veins for cannulation or repeated venipuncture.
Body mass index (BMI) between 18.0 and 30.0 kg/m², inclusive, and body weight of at least 50 kg.
Female participants of childbearing potential must have a negative serum or urine pregnancy test and must agree to use highly effective contraception throughout the study and follow-up period.
Male participants must agree to use adequate contraception and refrain from sperm donation during the study and for the protocol-specified period after the last dose.
Disqualifiers
Any clinically significant disease or medical condition that may interfere with study participation or interpretation of results.
History or presence of gastrointestinal, hepatic, renal or any other condition known to interfere absorption, distribution, metabolism, or excretion of study drugs.
Any clinically important illness, medical/surgical procedure, or trauma.
Active systemic bacterial, viral, or fungal infection.
Trial design
Design model
Sequential
Treatments tested in this trial
AZD4144
DrugAZD4144 will be administered orally.
AZD4144
DrugAZD4144 will be administered as an IV infusion.
Itraconazole
DrugItraconazole will be administered orally.
Treatment groups
32 Participants
are divided into 2 treatment groupsGroup A: Arm 1: Oral AZD4144Experimental treatment 2 interventions
Group B: Arm 2: IV Infusion AZD4144Experimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Area 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 162
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 163
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 16Secondary outcomes
1
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 162
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 163
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 164
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
Time frame
Period 1: Day 1 to Day 6; Period 3: Day 10 to Day 16Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov