Chronic Stable AnginaEarly Phase 1NCT06249581
Pharmacokinetics of AUX-001 40mg Once-daily in Healthy Subjects Under Fasting and Fed Conditions
A Early Phase 1 study testing AUX-001 40mg once-daily in people with Chronic Stable Angina, run by Auxilius Pharma sp.z.o.o. at 1 site in Portugal.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Stable Angina
- What is being tested?
- AUX-001 40mg once-daily
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 sitePortugal
- Study dates
- 27 Nov 2023to 10 Feb 2024
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
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- No clinically relevant abnormalities on 12-lead EKG.
- No clinically relevant abnormalities on laboratory tests.
- Neg. test results on anti-HIV-1Ab and anti-HIV-2Ab, HbsAG and anti-HCVAb
- Non-smoker or ex-smoker
- Willingness to accept and comply with all study procedures and restrictions.
- 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.
Who cannot join
- 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.
- History of severe hypotension or shock.
- History of acute pulmonary edema, heart failure, coronary artery disease or myocardial infarction.
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- History of orthostatic hypotension, collapse, fainting, syncope, or vasovagal reaction.
- History of substance or alcohol abuse within the previous 2 years.
- Use of contact lenses.
- SBP <95 mmHg and/or DBP <45 mmHg.
- Serum transaminases alanine aminotransferase (ALT) or aspartate aminotransferase (AST) above the upper limit of the normal range.
- 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.
- Positive result in drugs-of-abuse or ethanol tests.
- Use of a depot injection or an implant of any drug (except for contraceptives) within the previous 6 months.
- Average weekly alcohol consumption of >14 units for males and >7 units for females within the previous 6 months.
- Average daily consumption of methylxanthines-containing beverages or food (e.g., coffee, tea, cola, sodas, chocolate) equivalent to >500 mg of methylxanthines.
- Participation in any clinical trial within the previous 2 months.
- Participation in more than 2 clinical trials within the previous 12 months.
- Blood donation or significant blood loss (≥ 450 mL) due to any reason or had plasmapheresis within the previous 2 months.
- 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.
- Veins unsuitable for intravenous puncture on either arm.
- Difficulty in swallowing capsules or tablets.
- If woman of childbearing potential (WOCBP), positive pregnancy test.
- If woman, she is breast-feeding.
- Any other condition that the Investigator considers to render the subject unsuitable for the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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.
- Conditions
- Chronic Stable Angina
- Being tested
- AUX-001 40mg once-daily
- Keywords
- Pharmacokinetics, Bioavailability, Safety, Tolerability, Fasting, Fed
- Medical subject headings
- Angina, Stable, Fasting, Lecithin Cholesterol Acyltransferase Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AUX-001 40mg once-dailyDrug
Also called Food effect
AUX-001 (extended-release nicorandil) 40mg QD (once-daily)
| Study group | Role | What they receive |
|---|---|---|
| Arm A: fasting | Experimental | AUX-001 40mg QD Receives: Drug: AUX-001 40mg once-daily |
| Arm B: fed | Experimental | AUX-001 40mg QD Receives: Drug: AUX-001 40mg once-daily |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the curve over 24 hours [AUC0-24h)] of nicorandil under fasting conditions
Total nicorandil plasma concentration over 24 hours under fasting conditions
Measured: 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
Measured: 24 hours
Maximum Plasma Concentration [Cmax] of nicorandil under fasting conditions
Peak plasma concentration under fasting conditions in mcg/ml
Measured: 24 hours
Maximum Plasma Concentration [Cmax] of nicorandil under fed conditions
Peak plasma concentration under fed conditions in mcg/ml
Measured: 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
Measured: 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
Measured: 24 hours
Secondary outcomes (2)
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
Measured: 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
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2024
- Study start27 Nov 2023
- Primary completion8 Feb 2024 (estimated)
- Study completion10 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Stable AnginaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Single-dose clinical trial with healthy volunteers sequentially using a single dose of AUX-001 under fasting and thereafter under fed conditions
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Auxilius Pharma sp.z.o.o.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Marlene Fonseca, MD, Principal investigator, Blueclinical, Ltd.Uwe P Tigör, MD, Study director, Auxilius Pharma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06249581
- Sponsor's protocol ID
- 2023-506085-31-00
- Other IDs
- 2023
- Status last verified
- Feb 2024
- First submitted
- 20 Dec 2023
- Last updated
- 12 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06249581
- Acronym / sponsor ID
- 2023-506085-31-00
- Conditions
- Chronic Stable Angina
- Keywords
- Pharmacokinetics, Bioavailability, Safety, Tolerability, Fasting, Fed
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Auxilius Pharma sp.z.o.o.Industry (pharma, biotech, devices)
- Study start
- 27 Nov 2023 (actual)
- Primary completion
- 8 Feb 2024 (estimated)
- Study completion
- 10 Feb 2024 (estimated)
- First posted
- 8 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Single-dose clinical trial with healthy volunteers sequentially using a single dose of AUX-001 under fasting and thereafter under fed conditions
| Arm | Type | Receives |
|---|---|---|
| Arm A: fasting | Experimental | Drug: AUX-001 40mg once-dailyAUX-001 40mg QD |
| Arm B: fed | Experimental | Drug: AUX-001 40mg once-dailyAUX-001 40mg QD |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- 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.
Key exclusion criteria (25 listed)
- 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.
- History of severe hypotension or shock.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AUX-001 40mg once-dailyAlso: Food effectAUX-001 (extended-release nicorandil) 40mg QD (once-daily) | Drug | Arm A: fasting, Arm B: fed |
Primary outcome
Area under the curve over 24 hours [AUC0-24h)] of nicorandil under fasting conditions
Time frame: 24 hours
Total nicorandil plasma concentration over 24 hours under fasting conditions
Area under the curve over 24 hours [AUC0-24h)] of nicorandil under fed conditions
Time frame: 24 hours
Total nicorandil plasma concentration over 24 hours under fed conditions
Maximum Plasma Concentration [Cmax] of nicorandil under fasting conditions
Time frame: 24 hours
Peak plasma concentration under fasting conditions in mcg/ml
Maximum Plasma Concentration [Cmax] of nicorandil under fed conditions
Time frame: 24 hours
Peak plasma concentration under fed conditions in mcg/ml
24 hour Area Under the Curve [AUC0-24h] of N-(2-hydroxyethyl) nicotinamide under fasting conditions
Time frame: 24 hours
24 hour Total Plasma Concentration of nicorandil's main metabolite under fasting conditions
24h hour Area Under the Curve [AUC0-24h] of N-(2-hydroxyethyl) nicotinamide under fed conditions
Time frame: 24 hours
Total Plasma Concentration of nicorandil's main metabolite under fed conditions
2 secondary outcomes
Treatment-emergent adverse events [TEAE] under fasting conditions
Time frame: 24 hours
Treatment-emergent adverse events [TEAE] under fed conditions
Time frame: 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marlene Fonseca, MD principal investigator
Blueclinical, Ltd.
Uwe P Tigör, MD study director
Auxilius Pharma
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing AUX-001 40mg once-daily in people with Chronic Stable Angina, run by Auxilius Pharma sp.z.o.o. at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under the curve over 24 hours [AUC0-24h)] of nicorandil under fasting conditions (time frame: 24 hours). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2024.