A Study to Investigate the Pharmacokinetics of Different Formulations and Safety of AZD5004 in He… (NCT07455825) | Clinical Trial Compass
CompletedPhase 1
A Study to Investigate the Pharmacokinetics of Different Formulations and Safety of AZD5004 in Healthy Participants Aged 18 to 55 Years
United States65 participantsStarted 2026-03-05
Plain-language summary
The purpose of this study is to assess the pharmacokinetics (PK), safety and tolerability of different oral formulations of AZD5004, and to evaluate the effect of food on these formulations in healthy participants.
Who can participate
Age range
18 Years – 55 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. of childbearing potential must not be lactating and if heterosexually active must agree to use an approved method of highly effective contraception, to avoid pregnancy.
. of non-childbearing potential must be confirmed at the Screening Visit.
. Sexually active fertile male participants with partners of childbearing potential must adhere to the contraception methods.
. Additional contraception must be used for the sexual partners of male study participants throughout the clinical study.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial tested AZD5004 in healthy participants aged 18 to 55 — can you help me understand what this Phase 1 pharmacokinetics study tells us about how the drug is absorbed and processed by the body, and what that means for its potential development?
2Since this trial compared different formulations of AZD5004 and measured things like peak concentration and how long the drug stays in the body, does the data suggest any formulation performed more predictably or safely than others?
3Because this was a Phase 1 study in healthy volunteers and is now completed, how much do we actually know so far about whether AZD5004 might eventually be relevant for patients with a condition like mine, and are there later-phase trials planned or underway?
4Given that Phase 1 trials are primarily focused on safety and how the body handles the drug rather than effectiveness, what would need to happen in future trials before AZD5004 could be considered a realistic treatment option?
5Are there any safety signals or findings from this completed trial that you think are worth knowing about if I'm considering following the development of AZD5004 or participating in any future studies?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Area under concentration-time curve from time 0 extrapolated to infinity (AUCinf)
Timeframe: From Day 1 to Day 22
2
Area under concentration-curve from time 0 to the time of last quantifiable concentration (AUClast)