An Early Phase 1 interventional study of AUX-001 40mg once-daily in Chronic Stable Angina, sponsored by Auxilius Pharma sp.z.o.o.. Active, not recruiting at 1 site in Portugal. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-02-12.
Sponsored by Auxilius Pharma sp.z.o.o. · Early Phase 1, Interventional, and Treatment
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.
This is a first-in-human, exploratory, single-dose, open-label pharmacokinetic study to explore the uptake, and systemic distribution of orally administered AUX-001 in healthy volunteers on an empty stomach (i.e, fasting) as well as after a meal (i.e. fed) in male and female healthy volunteers age 18 to 55 to establish pharmacokinetics, safety, tolerability and whether the medication can be given independent of any food effect.
345 studies on the registry are indexed under Angina, Stable; 56 are open to participants now.
This study's enrollment of 16 is below the median of 150 across 236 interventional studies indexed under Angina, Stable.
Browse Angina, Stable studies →This is the only study on the registry with Auxilius Pharma sp.z.o.o. as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
AUX-001 40mg QD
Drug: AUX-001 40mg once-daily
AUX-001 40mg QD
Drug: AUX-001 40mg once-daily
AUX-001 (extended-release nicorandil) 40mg QD (once-daily)
Also known as: Food effect
Area under the curve over 24 hours [AUC0-24h)] of nicorandil under fasting conditions
Total nicorandil plasma concentration over 24 hours under fasting conditions
Time frame: 24 hours
Area under the curve over 24 hours [AUC0-24h)] of nicorandil under fed conditions
Total nicorandil plasma concentration over 24 hours under fed conditions
Time frame: 24 hours
Maximum Plasma Concentration [Cmax] of nicorandil under fasting conditions
Peak plasma concentration under fasting conditions in mcg/ml
Time frame: 24 hours
Maximum Plasma Concentration [Cmax] of nicorandil under fed conditions
Peak plasma concentration under fed conditions in mcg/ml
Time frame: 24 hours
24 hour Area Under the Curve [AUC0-24h] of N-(2-hydroxyethyl) nicotinamide under fasting conditions
24 hour Total Plasma Concentration of nicorandil's main metabolite under fasting conditions
Time frame: 24 hours
24h hour Area Under the Curve [AUC0-24h] of N-(2-hydroxyethyl) nicotinamide under fed conditions
Total Plasma Concentration of nicorandil's main metabolite under fed conditions
Time frame: 24 hours
Treatment-emergent adverse events [TEAE] under fasting conditions
Occurrence of treatment-emergent adverse events (TEAEs) including vital signs, pulse oximetry, EKG, liver function tests \[LFT\] under fasting conditions
Time frame: 24 hours
Treatment-emergent adverse events [TEAE] under fed conditions
Occurrence of treatment-emergent adverse events (TEAEs) including vital signs, pulse oximetry, EKG, liver function tests \[LFT\] under fed conditions
Time frame: 24 hours
Plan to share: No
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.