CompletedPhase 1ACTRN12624001294549

A 2-part Phase I study to evaluate the safety, tolerability, pharmacokinetics and food effects of AXN-027

A 2-part Phase I study to evaluate the safety, tolerability, pharmacokinetics including food effect and relative bioavailability of capsules vs tablets, and pharmacodynamic effects of AXN-027 in healthy adult volunteers

Sponsor

Axonis Australia Pty Ltd

Enrollment

80 participants

Start Date

Dec 4, 2024

Study Type

Interventional

Conditions

Epilepsy

Summary

This study in healthy volunteers aims to identify the range of safe single and multiple doses of AXN-027 Salt administered by mouth; to assess how the body handles AXN-027 Salt; how AXN-027 Salt contained in capsules compares to AXN-027 Salt contained in a tablet, what effect a high fat meal has on how the body handles AXN-027 absorption and to evaluate the safety of AXN-027 Salt compared to placebo. The results of this study will help identify appropriate doses of AXN-027 Salt to evaluate in future clinical trials.

Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 55 Yearss

Inclusion Criteria4

Female or male and between the ages of 18 and 55 years, inclusive.
Weight of at least 50 kg for men and at least 45 kg for women, with body mass index (BMI) between 18.5 and 32 kg/m2 (inclusive).
Medically healthy (without significant medical issues, e.g. high blood pressure)
Must provide written informed consent

Exclusion Criteria6

Ongoing or history of any psychiatric, medical or surgical condition that might jeopardize the participant’s safety or interfere with the absorption, distribution, metabolism or excretion of the study drug.
Any abnormal ECG findings, laboratory value or physical examination findings
Positive ethanol, drug screen or cotinine test
Use of systemic prescription medications or over-the-counter (OTC) medication, including multivitamins, and dietary and herbal supplement within 7 days
Use of any experimental or investigational drug or device within 30 days
Donation or loss of 480 mL or more of blood within 30 weeks and/or donation of plasma within 30 days

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

Participants will be confined at the site during the dosing period where dosing will be done via direct supervision and they can only participate in one of the following cohorts: - Part 1 cohorts 1,

Participants will be confined at the site during the dosing period where dosing will be done via direct supervision and they can only participate in one of the following cohorts: - Part 1 cohorts 1, 2, 3, 5, 6 (oral capsule or tablet): Screening/ baseline period of up to 28 days with total duration up to 42 days. Single ascending doses of AXN-027 Salt between 100 mg and 2400 mg or placebo (Day 1) administered under fasting conditions. Increases will be based on safety and tolerability at each dose level. -Part 1 cohort 4: (oral capsule and tablets): Screening/baseline period of up to 28 days with total duration up to 56 days. Three single doses of AXN-027 Salt between 100 mg and 2400 mg or placebo (one capsule and two tablets) administered either fasted or with a high fat, high calorie meal with a 7-day washout between each dose. According to FDA guidance, 'high fat' is an 800-1000 calorie meal with 60% of the calories from fat. An example of a high fat meal is two eggs fried in butter, two strips of bacon, two slices of toast with butter, four ounces of hash brown potatoes and eight ounces of whole milk - with the whole meal containing approximately 60% fat. -Part 1 SAD CSF Cohort (oral capsule or tablet): Screening/ baseline period of up to 28 days with total duration up to 42 days. Single dose of AXN-027 Salt (dose to be confirmed by the SRC; Day 1) administered under fasting conditions. - Part 2 (oral tablet): screening/ baseline period of up to 28 days with total duration up to 48 days. Twice daily doses of up to 1800 mg AXN-027 Salt or placebo (Day 1-8, with last dose in the morning of Day 8; not exceeding total daily dose of 3600 mg) administered under fasted or fed conditions Exact dose of AXN-027 Salt for Part 1 cohorts 2-6 and Part 2 will be based on safety, tolerability and PK data from initial cohorts of Part 1. After all participants in a cohort are discharged from the site, a safety review committee (SRC) will determine if the next dose level cohort will be initiated. Each consecutive cohort will start approximately 2 weeks after the previous cohort are discharged from the site. Adherence to dosing will be assessed by direct observation of dosing at the site and site direct provision of dose for each timepoint.