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

NCT ID: NCT06249581

Last Updated: 2024-02-12

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-27
• Study Completion Date: 2024-02-10

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm A: fasting

AUX-001 40mg QD

Group Type: EXPERIMENTAL

AUX-001 40mg once-daily

Intervention Type: DRUG

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

Arm B: fed

AUX-001 40mg QD

Group Type: EXPERIMENTAL

AUX-001 40mg once-daily

Intervention Type: DRUG

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

Interventions

AUX-001 40mg once-daily

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

Intervention Type: DRUG

Other Intervention Names

Food effect

Eligibility Criteria

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

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Auxilius Pharma sp.z.o.o.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marlene Fonseca, MD

Role: PRINCIPAL_INVESTIGATOR

Blueclinical, Ltd.

Uwe P Tigör, MD

Role: STUDY_DIRECTOR

Auxilius Pharma

Locations

BlueClinical

Porto, , Portugal

Countries

Portugal

Other Identifiers

2023-506085-31-00

Identifier Type: -

Identifier Source: org_study_id