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Active, not recruitingNCT06249581Updated Feb 12, 2024

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

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

From the registry’s dates

  • Primary completion was expected by Feb 2024, 2 years 7 months ago, but the record still lists the study as active, not recruiting.
Phase
Early Phase 1
Study type
Interventional
Enrollment
16
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Chronic Stable Angina

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Keywords

  • Pharmacokinetics
  • Bioavailability
  • Safety
  • Tolerability
  • Fasting
  • Fed
03

In context

Angina, Stable

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 →

Lead sponsor

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.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  1. Free written informed consent signed and dated prior to any procedure required by the study.
  2. Male or female subject between 18 and 55years, inclusive, at the time of signing the informed consent.
  3. Body mass index (BMI) of 18.0 to 31.0 kg/m2, inclusive.
  4. No clinically relevant diseases captured in medical history.
  5. No clinically relevant abnormalities on physical examination.
  6. No clinically relevant abnormalities on vital signs.
  7. No clinically relevant abnormalities on 12-lead EKG.
  8. No clinically relevant abnormalities on laboratory tests.
  9. Neg. test results on anti-HIV-1Ab and anti-HIV-2Ab, HbsAG and anti-HCVAb
  10. Non-smoker or ex-smoker
  11. Willingness to accept and comply with all study procedures and restrictions.
  12. Female subject of a) non-child-bearing potential or b) of childbearing potential and agrees to use an accepted, highly effective contraceptive method until the end of the study.

Exclusion criteria

Exclusion Criteria:

  1. Known hypersensitivity/allergy reaction to the study drug substance or any of the excipients.
  2. Known severe hypersensitivity reaction to any other drug.
  3. 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.
  4. History of glucose-6-phosphate dehydrogenase deficiency.
  5. History of severe hypotension or shock.
  6. History of acute pulmonary edema, heart failure, coronary artery disease or myocardial infarction.
  7. History of orthostatic hypotension, collapse, fainting, syncope, or vasovagal reaction.
  8. History of substance or alcohol abuse within the previous 2 years.
  9. Use of contact lenses.
  10. SBP \<95 mmHg and/or DBP \<45 mmHg.
  11. Serum transaminases alanine aminotransferase (ALT) or aspartate aminotransferase (AST) above the upper limit of the normal range.
  12. Estimated renal creatinine clearance (CLCr) below the lower limit of normal range, based on creatinine clearance calculation by the Cockcroft-Gault formula and normalized to an average body surface area of 1.73 m2.
  13. Positive result in drugs-of-abuse or ethanol tests.
  14. Use of a depot injection or an implant of any drug (except for contraceptives) within the previous 6 months.
  15. Average weekly alcohol consumption of >14 units for males and >7 units for females within the previous 6 months.
  16. Average daily consumption of methylxanthines-containing beverages or food (e.g., coffee, tea, cola, sodas, chocolate) equivalent to >500 mg of methylxanthines.
  17. Participation in any clinical trial within the previous 2 months.
  18. Participation in more than 2 clinical trials within the previous 12 months.
  19. Blood donation or significant blood loss (≥ 450 mL) due to any reason or had plasmapheresis within the previous 2 months.
  20. Difficulty in fasting or any dietary restriction such as lactose intolerance, vegan, low-fat, low sodium, etc., that may interfere with the diet served during the study.
  21. Veins unsuitable for intravenous puncture on either arm.
  22. Difficulty in swallowing capsules or tablets.
  23. If woman of childbearing potential (WOCBP), positive pregnancy test.
  24. If woman, she is breast-feeding.
  25. Any other condition that the Investigator considers to render the subject unsuitable for the study.
05

Study design

Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
16 participants (actual)

Study arms

  • Experimental
    Arm A: fasting

    AUX-001 40mg QD

    Drug: AUX-001 40mg once-daily

  • Experimental
    Arm B: fed

    AUX-001 40mg QD

    Drug: AUX-001 40mg once-daily

Interventions

  • DrugAUX-001 40mg once-daily

    AUX-001 (extended-release nicorandil) 40mg QD (once-daily)

    Also known as: Food effect

06

What researchers measure

Primary outcomes

  1. 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

  2. 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

  3. Maximum Plasma Concentration [Cmax] of nicorandil under fasting conditions

    Peak plasma concentration under fasting conditions in mcg/ml

    Time frame: 24 hours

  4. Maximum Plasma Concentration [Cmax] of nicorandil under fed conditions

    Peak plasma concentration under fed conditions in mcg/ml

    Time frame: 24 hours

  5. 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

  6. 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

Secondary outcomes

  1. 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

  2. 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

07

Study locations

1 site
  • BlueClinical
    Porto, 4250-449, Portugal
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 12, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06249581
Lead sponsor
Auxilius Pharma sp.z.o.o.
Responsible party
Sponsor
First posted
Feb 8, 2024
Start date
Nov 27, 2023
Primary completion
Feb 8, 2024 (estimated)
Completion
Feb 10, 2024 (estimated)
Last update
Feb 12, 2024

Study contacts

Marlene Fonseca, MD
principal investigator · Blueclinical, Ltd.
Uwe P Tigör, MD
study director · Auxilius Pharma

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.

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