Study to Assess Relative Bioavailability and Safety of AZD5718 in Healthy Volunteers (NCT04734275) | Clinical Trial Compass
CompletedPhase 1
Study to Assess Relative Bioavailability and Safety of AZD5718 in Healthy Volunteers
United Kingdom16 participantsStarted 2021-02-01
Plain-language summary
This study will be a randomised, open-label, 3-period, 3-treatment, single-dose, crossover study in healthy subjects The study will be performed at a single study centre in the United Kingdom.
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.
Only key inclusion and exclusion criteria are presented here:
Inclusion Criteria:
* Healthy male and/or female subjects aged 18 - 55 years inclusive with suitable veins for cannulation or repeated venipuncture.
* Females must have a negative serum pregnancy test at the Screening Visit and a negative urine pregnancy test at each admission to the unit, must not be lactating and must be of nonchildbearing potential, confirmed at the Screening Visit.
* Male subjects must adhere to the contraception methods as detailed in protocol.
* Have a body mass index between 18.5 and 30 kg/m\^2 inclusive and weigh at least 50 kg and no more than 100 kg inclusive.
Exclusion Criteria:
* History of any clinically significant disease or disorder which, in the opinion of the principal investigator (PI), may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study.
* History or presence of gastrointestinal, hepatic or renal disease, or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs.
* Any clinically significant illness, medical/surgical procedure, or trauma within 4 weeks of the first administration of Investigational Medicinal Product (IMP).
* Any clinically significant abnormalities in clinical chemistry, haematology, coagulation, or urinalysis results, at the Screening Visit and/or on admission to the Clinical Unit for Treatment Period 1 as judg…
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.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
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 plasma concentration-time curve from zero to infinity (AUCinf) (Treatment A versus Treatment C)
Timeframe: Days 1, 2 and 3 of each Treatment Period (pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36 and 48 hours)
2
Area under the plasma concentration-time curve from zero to the last quantifiable concentration (AUClast) (Treatment A versus Treatment C)
Timeframe: Days 1, 2 and 3 of each Treatment Period (pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36 and 48 hours)
3
Maximum observed plasma (peak) drug concentration (Cmax) (Treatment A versus Treatment C)
Timeframe: Days 1, 2 and 3 of each Treatment Period (pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36 and 48 hours)
4
Plasma concentration at 24h post-dose (C24) (Treatment A versus Treatment C)
Timeframe: Days 1, 2 and 3 of each Treatment Period (pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36 and 48 hours)
5
AUCinf (Treatment B versus Treatment A)
Timeframe: Days 1, 2 and 3 of each Treatment Period (pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36 and 48 hours)