Safety, Tolerability, and Exploratory Efficacy of AGP100 in Patients With Catecholaminergic Polymorphic Ventricular Tachycardia (CPVT)

Summary

This trial is conducted in patients with an inherited heart rhythm disorder called catecholaminergic polymorphic ventricular tachycardia (CPVT). This condition causes the heart to beat dangerously fast during situations of physical or emotional stress. CPVT is a serious condition that can limit the length and quality of patients' lives. Current treatment does not always prevent the abnormal heart rhythms that can occur as part of CPVT during strenuous exercise or stress, so new and improved medications are needed.

The main questions that the trial will answer are:

* How safe and tolerable is the drug AGP100; i.e, what medical problems do patients experience when taking the drug?
* Does the drug help CPVT patients to maintain a normal heart rhythm while they are exercising?
* How does the drug affect the levels of key heart cell signalling molecules?

Patients with a diagnosis of CPVT who are aged between 18 and 75 and experience abnormal heart rhythms during exercise, despite taking a stable dose of the medication(s) prescribed by their doctor for their CPVT can take part in this trial. Participants should have normal kidney and liver function and not have high blood pressure or a diagnosis of structural heart disease. Women who are pregnant or breastfeeding cannot take part in the study. Participants who may become pregnant (and their partners) need to use highly effective methods of contraception during the study and for 90 days after the study ends.

Participants will take part in the study for ten weeks. During this time, participants will be asked to take three different doses of the the drug (AGP100), as well as their normal heart medication. The drug is an oral capsule and each different dose will be taken once a day for 13 days. The study starts with participants taking a low dose for 2 weeks, then a medium dose and then a high dose. At each dose, participants will undergo a clinical examination, report any potential side effects and the treating doctor will investigate the safety, tolerability and side effects of AGP100. In total, participants will take AGP100 once a day for about six weeks. The last four weeks of the study will be a follow-up period where participants will not take AGP100.

During the study, participants will need to visit the hospital six times. The visits will be three outpatient appointments and three overnight stays.

Conditions

• Catecholaminergic Polymorphic Ventricular Tachycardia

Interventions

DRUG

AGP100

AGP100 is a capsule for oral administration. The drug substance is formulated as an encapsulated dry powder blend composed of 5 mg or 25 mg active ingredient and inactive excipients filled into a white, opaque, size 3 hard gelatine capsule. The drug product is a white to light brown solid, with low solubility in water. During study visits, participants will take IMP under supervision of the study staff. Participants will receive with the oral dose together with water. During the rest of each treatment period, participants will self-administer the IMP. Doses should be taken with water, as needed. Participants are to continue to take the IMP once per day until they attend the study visit that starts the next treatment period/the end of study visit.

Sponsors & Collaborators

• Link Medical Research AS

  collaborator UNKNOWN

• Viedoc Technologies AB

  collaborator UNKNOWN

• Vitas AS

  collaborator OTHER_GOV

• Agiana Pharmaceuticals

  lead INDUSTRY

Principal Investigators

• Rizwan Hussain, MD PhD · Agiana Pharmaceuticals AS

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-01-02

Primary Completion

2027-06-30

Completion

2027-06-30

Countries

• Norway

Study Locations