The Efficacy, Safety and Tolerability of Oral NP202 in Adults who have Paroxysmal Atrial Fibrillation and a Cardiac Device

A Phase II Randomised, Double-Blind, Placebo-Controlled Study of the Efficacy, Safety and Tolerability of Oral NP202 in Adults who have Paroxysmal Atrial Fibrillation and a Cardiac Device

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12618001692224

Acronym

NP202-AF

Enrollment

Registered

2018-10-12

Start date

2018-06-21

Completion date

2020-01-31

Last updated

2018-11-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

NP202 has been shown to reduce rhythm disturbances in heart muscle in the ventricles, and it is compelling to discover if it similarly reduces rhythm disturbances in heart muscle in the atria. As AF is the most common rhythm disturbance in the atria, it is the most suitable target to investigate a benefit. This is a single-centre, randomised, double blind, placebo controlled study to assess the efficacy, safety and tolerability of NP202. Subjects will be screened during routine interrogation of their cardiac device. Eligible subjects will have a high burden of paroxysmal atrial fibrillation. They will be randomised and administered their first dose of investigational product (IP) on Study Day 1. Subjects will take their IP dose once a day for 1 month (30 days). During this treatment period they will return to the site for study visits at Week 2, and Months 1, 2, and 3. Month 3 is the end of the Treatment Period. Subject will return for follow up and the final study visit at Month 4. A Data Monitoring Committee (DMC) will review safety data at agreed recruitment and progression milestones to provide independent oversight of subject safety. Armaron Bio Pty Ltd has provided the study drug at no cost. They have not have provided any funding and the study investigators have full intellectual property and rights over the study data.

Interventions

Randomised trial of NP202 versus placebo. NP202 is a synthetic flavonol. The mechanism of action is thought to be inhibition of pro-apoptotic kinases of the death-associated protein kinase family. NP202 has been shown to reduce rhythm disturbances in heart muscle in the ventricles, and it is compelling to discover if it similarly reduces rhythm disturbances in heart muscle in the atria. As AF is the most common rhythm disturbance in the atria, it is the most suitable target to investigate a be

Study design

Allocation

Randomised controlled trial

Intervention model

Crossover

Primary purpose

Treatment

Masking

Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

18 Years to 80 Years

Healthy volunteers

Inclusion criteria

Participants who: • Age between 18-80 years. • Paroxysmal (not lasting more than 7 days) atrial fibrillation. • An implanted device (loop recorder, pacemaker or defibrillator). • An AF burden between 0.1-90% over the past 6 months.

Exclusion criteria

Participants with: • Pregnant or breastfeeding females. • Estimated glomerular filtration rate (eGFR) <30ml/min. • Liver function tests 3 x ULN due to non-cardiac disease. • Have received any investigational research agent within 30 days or 5 half-lives (whichever is longer) prior to the first dose of IP.

Outcome results