A Study to Investigate the Relative Bioavailability of 2 Different Formulations of AZD4144, the Eā¦ (NCT06948006) | Clinical Trial Compass
CompletedPhase 1
A Study to Investigate the Relative Bioavailability of 2 Different Formulations of AZD4144, the Effect of Food and Omeprazole on the Pharmacokinetics of AZD4144 in Healthy Participants
United Kingdom32 participantsStarted 2025-04-23
Plain-language summary
The main aim of this study to compare the pharmacokinetics (PK) of two formulations of AZD4144 and assess the effect of food and omeprazole on PK of AZD4144 in healthy participants.
Who can participate
Age range18 Years ā 55 Years
SexALL
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Inclusion criteria
ā. Signed the informed consent form before any study-related procedure.
ā. Healthy male and female participants with suitable veins for cannulation or repeated venipuncture.
ā. Negative pregnancy test for females at screening, first admission, and follow-up.
ā. Females of childbearing potential must use highly effective contraception from first dose until 3 months after last dose.
ā. Non-childbearing potential females must meet postmenopausal or surgical sterilization criteria.
ā. Sexually active fertile males must use contraception from first dose until 3 months after last dose.
ā. Body Mass Index (BMI) between 18-32 kg/m2 and weight ā„45 kg at screening and first admission.
Exclusion criteria
ā. History of any clinically important disease or disorder that may put the participant at risk or influence study results.
ā. History or presence of gastrointestinal, hepatic, or renal disease or any condition affecting drug absorption, distribution, metabolism, or excretion.
ā. Any clinically important illness, medical/surgical procedure, or trauma within 4 weeks of randomization.
ā. Active systemic bacterial, viral, or fungal infection within 14 days prior to dosing or presence of fever within 14 days prior to dosing.
What they're measuring
1
Area under concentration-time curve from time 0 to infinity (AUCinf) of AZD4144
Timeframe: Days 1-4, Days 8-11 and Days 15-18
2
Area under concentration-curve from time 0 to the last quantifiable concentration (AUClast) of AZD4144
Timeframe: Days 1-4, Days 8-11 and Days 15-18
3
Maximum observed drug concentration (Cmax) of AZD4144