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 range18 Years – 55 Years
SexALL
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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.
✕. History of glucose-6-phosphate dehydrogenase deficiency.
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