NCT07685600 Investigating the Effect of Itraconazole on the Pharmacokinetics of AZD4144 in Healthy Participants
| NCT ID | NCT07685600 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | AstraZeneca |
| Condition | Healthy |
| Study Type | INTERVENTIONAL |
| Enrollment | 32 participants |
| Start Date | 2026-07-30 |
| Primary Completion | 2026-10-29 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 32 participants in total. It began in 2026-07-30 with a primary completion date of 2026-10-29.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
Inclusion Criteria: 1. Healthy male and/or female participants with suitable veins for cannulation or repeated venipuncture. 2. Body mass index (BMI) between 18.0 and 30.0 kg/m², inclusive, and body weight of at least 50 kg. 3. 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. 4. 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. Exclusion Criteria: 1. Any clinically significant disease or medical condition that may interfere with study participation or interpretation of results. 2. History or presence of gastrointestinal, hepatic, renal or any other condition known to interfere absorption, distribution, metabolism, or excretion of study drugs. 3. Any clinically important illness, medical/surgical procedure, or trauma. 4. Active systemic bacterial, viral, or fungal infection. 5. Clinically significant serious active or chronic infections. 6. Known history of primary immunodeficiency (congenital or acquired) or an underlying condition that predisposes to infection. 7. Concomitant immunosuppressive, steroid treatment. 8. Clinically significant abnormalities in physical examination, vital signs, 12-lead electrocardiogram (ECG), or clinical laboratory assessments. 9. Known hypersensitivity or allergy to AZD4144, itraconazole, or any excipients of the study interventions. 10. Positive screening test for drugs of abuse, alcohol, hepatitis B virus, hepatitis C virus, or human immunodeficiency virus (HIV).
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07685600 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 55 Years, studying Healthy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07685600 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07685600 currently recruiting?
Yes, NCT07685600 is actively recruiting participants. Contact the research team at information.center@astrazeneca.com for enrollment information.
Where is the NCT07685600 trial being conducted?
This trial is being conducted at Harrow, United Kingdom.
Who is sponsoring the NCT07685600 clinical trial?
NCT07685600 is sponsored by AstraZeneca. The trial plans to enroll 32 participants.