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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
16
AUX-001 (extended-release nicorandil) 40mg QD (once-daily)
BlueClinical
Porto, Portugal
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
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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