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Propafenone · 1 trial · 1 indication
Two formulations of propafenone hydrochloride
| Arm | Type | Description |
|---|---|---|
| Propafenone | OTHER | Open label comparison of 2 formulations |
| Name | Type | Description |
|---|---|---|
| Propafenone | DRUG | Comparison of drug from 2 manufacturing sites |
Inclusion Criteria: * Male or female between 18 and 55 years of age inclusive, at the time of signing the informed consent. * Body weight greater than or equal to 50kg and BMI within the range 18.5 - 31.0kg/m2 (inclusive). * Healthy as determined by a responsible and experienced physician, based on...
Propafenone is a small molecule developed by GSK plc for arrhythmia and cardiac conditions. It is in Phase 1 clinical development. The only listed trial is a bioequivalence study of RYTHMOL SR manufactured at two different sites, conducted in the United States with 38 healthy adult volunteers.
Propafenone targets ADRB1, ADRB2, SCN1A, SCN5A, SCN4A, and SCN7A. It acts as an antagonist at these targets. The adrenergic receptors ADRB1 and ADRB2 and the sodium channel subunits SCN1A, SCN5A, SCN4A, and SCN7A are the molecular targets identified for this small molecule.
GSK plc, which trades under the ticker GSK, is the developer of Propafenone. The company is listed as the sponsor of the clinical program for this small molecule in arrhythmia and cardiac indications.
Propafenone is in Phase 1 clinical development. It is an investigational small molecule and is not stated to be approved. The program includes one completed Phase 1 trial with 38 participants, and no active trials are listed.
Propafenone has been studied in NCT01956487, titled Bioequivalence of RYTHMOL SR Manufactured at Two Different Sites. This completed Phase 1 trial enrolled 38 healthy volunteers in the United States, with participants aged 18 years and older of all sexes. It was an uncontrolled, non-randomized, non-double-blind study.