Pharmacokinetics of AUX-001 40mg Once-daily in Healthy Subjects Under Fasting and Fed Conditions (NCT06249581) | Clinical Trial Compass
UnknownEarly Phase 1
Pharmacokinetics of AUX-001 40mg Once-daily in Healthy Subjects Under Fasting and Fed Conditions
Portugal16 participantsStarted 2023-11-27
Plain-language summary
Exploratory, single-dose, open-label, pharmacokinetic study to establish uptake, plasma levels safety and tolerability of orally administered AUX-001 on an empty stomach (i.e, fasting) as well as after a meal (i.e. fed) in healthy volunteers.
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
. Free written informed consent signed and dated prior to any procedure required by the study.
. Male or female subject between 18 and 55years, inclusive, at the time of signing the informed consent.
. Body mass index (BMI) of 18.0 to 31.0 kg/m2, inclusive.
. No clinically relevant diseases captured in medical history.
. No clinically relevant abnormalities on physical examination.
. No clinically relevant abnormalities on vital signs.
. No clinically relevant abnormalities on 12-lead EKG.
. No clinically relevant abnormalities on laboratory tests.
Exclusion criteria
. Known hypersensitivity/allergy reaction to the study drug substance or any of the excipients.
. Known severe hypersensitivity reaction to any other drug.
. Any medical condition (e.g., gastrointestinal, renal or hepatic, including peptic ulcer, inflammatory bowel disease or pancreatitis) or surgical condition (e.g., cholecystectomy, gastrectomy) that may affect drug pharmacokinetics (absorption, distribution, metabolism or excretion) or subject's safety.
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 the curve over 24 hours [AUC0-24h)] of nicorandil under fasting conditions
Timeframe: 24 hours
2
Area under the curve over 24 hours [AUC0-24h)] of nicorandil under fed conditions
Timeframe: 24 hours
3
Maximum Plasma Concentration [Cmax] of nicorandil under fasting conditions
Timeframe: 24 hours
4
Maximum Plasma Concentration [Cmax] of nicorandil under fed conditions
Timeframe: 24 hours
5
24 hour Area Under the Curve [AUC0-24h] of N-(2-hydroxyethyl) nicotinamide under fasting conditions
Timeframe: 24 hours
6
24h hour Area Under the Curve [AUC0-24h] of N-(2-hydroxyethyl) nicotinamide under fed conditions