Overview

Study of LQT-1213 on Dofetilide-Induced QTc Prolongation in Healthy Adult Subjects and Patients Diagnosed With Type 2 or 3 Long QT Syndrome

Status:
Active, not recruiting

Trial end date:
2023-12-03

Target enrollment:

Participant gender:

Summary

Part 1: This is a Phase 1b, randomized, double-blind, crossover, dose escalation, placebo-controlled study to evaluate the effect of oral LQT-1213 on dofetilide-induced QTc prolongation in healthy adult subjects. This is a 2-treatment, 2-period crossover study with approximately up to 28 healthy subjects, with screening procedures within 28 days of enrolment. Part 2: This is a Phase 2a, single-blind, placebo run-in, multiple-dose safety study to evaluate the safety, tolerability, and PK of LQT-1213 in patients diagnosed with LQT2 or LQT3. Up to 12 patients diagnosed with LQT-2 and LQT-3 will undergo a one day, single blind run-in period followed by repeat doses of LQT-1213.

Phase:

Phase 1/Phase 2

Details

Lead Sponsor:

Thryv Therapeutics, Inc.

Treatments:

Dofetilide