NCT06249581

Pharmacokinetics of AUX-001 40mg Once-daily in Healthy Subjects Under Fasting and Fed Conditions

Pharmacokinetics of Nicorandil 40 mg Extended-Release Capsules: A Single-Dose, Open-Label, Randomized, Two-Sequence, Two-Treatment, Two-Period Crossover Study in Healthy Subjects Under Fasting and Fed Conditions

• Status: Unknown
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Auxilius Pharma sp.z.o.o. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Detailed description

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.

Conditions

• Chronic Stable Angina

Interventions

Type	Name	Description
DRUG	AUX-001 40mg once-daily	AUX-001 (extended-release nicorandil) 40mg QD (once-daily)

Timeline

• Start date: 2023-11-27
• Primary completion: 2024-02-08
• Completion: 2024-02-10
• First posted: 2024-02-08
• Last updated: 2024-02-12

Locations

1 site across 1 country: Portugal