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Safety and Efficacy of LQT-1213 in Healthy Subjects and Patients with LQT2 or LQT3
NCT05906732Phase 2
Key facts
- Status
- Terminated
- Start
- Mar 2023
- Primary completion
- May 2024
- Countries
- 1
- Sponsor
- Thryv Therapeutics Inc.
- Modality
- Small Molecules
- Drugs
- LQT-1213
- Conditions
- Long QT syndrome type 2 (LQT2)Long QT Syndrome Type 3 (LQT3)
01
Overview
Phase 2, randomised, double-blind trial of LQT-1213 in Long QT syndrome type 2 (LQT2) and Long QT Syndrome Type 3 (LQT3) (4 arms), sponsored by Thryv Therapeutics Inc. Primary endpoints: Pharmacodynamics: By-time Point Analysis for QTc on LQT-1213 Versus Placebo at Day 8 and Safety and Tolerability of Oral LQT-1213 in Participants With LQT-2 or LQT-3. Started Mar 2023; status: terminated.
02
Design
4 arms- Study design
- RandomizedDouble-blind
Part 1 Arm A
Dofetilide + LQT-1213 then Dofetilide + Placebo
Part 1 Arm B
Dofetilide + Placebo then Dofetilide + LQT-1213
Part 2 16mg
LQT-1213 16 mg TID
Part 2 7mg
LQT-1213 7 mg TID
03
Who it enrols
Part 1 includes healthy adults 18-60. Part 2 includes adults 18+ with LQT2 or LQT3 mutations, QTcF 480-560ms, and ICD/pacemaker requirements.
04
Endpoints
Primary
Pharmacodynamics: By-time Point Analysis for QTc on LQT-1213 Versus Placebo
Safety and Tolerability of Oral LQT-1213 in Participants With LQT-2 or LQT-3
Secondary
Pharmacokinetic LQT-1213 AUC0-t
05
Results
Not all primary endpoints met
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