Ignite Creation Date:
2024-05-06 @ 7:07 PM
Last Modification Date:
2024-10-26 @ 3:01 PM
Study NCT ID:
NCT05906732
Status:
RECRUITING
Last Update Posted:
2024-01-23
First Post:
2023-06-07
Brief Title:
Study of LQT-1213 on QTc-induced Prolongation in Healthy Adult Subjects Part1 and on Congenital Long QT in Patients Diagnosed With Type 1 2 or 3 Long QT Syndrome Part 2
Sponsor:
Thryv Therapeutics Inc
Organization:
Thryv Therapeutics Inc
Study Overview
Official Title:
A Phase 1b2a 2-Part Study Part 1 Randomized Double-Blind Crossover Dose-Escalation Placebo-Controlled Study to Evaluate the Safety Tolerability Pharmacokinetics and Pharmacodynamics of SGK-1 Kinase Inhibition by LQT-1213 on Dofetilide-Induced QTc Prolongation in Healthy Adult Subjects Part 2 Single-Blind Multiple-Dose Safety Study to Evaluate the Safety Tolerability and Pharmacokinetics of LQT-1213 in Patients Diagnosed With Type 1 2 or 3 Long QT Syndrome
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 LQT1 LQT2 or LQT3 Up to 12 participants with LQT1 up to 20 participants with LQT2 and up to 12 participants with LQT3 will be recruited
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 LQT1 LQT2 or LQT3 Up to 12 participants with LQT1 up to 20 participants with LQT2 and up to 12 participants with LQT3 will be recruited
Detailed Description:
Part 1 This is a 2-treatment 2-period crossover study Approximately 28 healthy subjects with the attempt to balance for sexes will be enrolled to complete approximately up to 20 subjects in the study In both treatment periods all subjects will receive dofetilide on Days 1 and 2 of each period Randomization will take place before Day 3 of Period 1 Subjects will be randomly assigned to 1 of 2 treatment sequences AB or BA
Part 2 Up to 12 participants with LQT1 up to 20 participants with LQT2 and up to 12 participants with LQT3 will be enrolled After initial screening which may be conducted remotely by the CRU individual participants with LQT1 LQT2 or LQT3 will undergo a 1-day single-blind placebo run-in period followed by 3 dosing days of LQT-1213 administered BID the last dosing day will have a single dose LQT-1213 will be administered BID on Days 2-4 Participants will be discharged from the CRU on Day 5 Approximately 7 days after discharge from the CRU the Follow-up Visit will be conducted remotely via telephone call
Part 2 Up to 12 participants with LQT1 up to 20 participants with LQT2 and up to 12 participants with LQT3 will be enrolled After initial screening which may be conducted remotely by the CRU individual participants with LQT1 LQT2 or LQT3 will undergo a 1-day single-blind placebo run-in period followed by 3 dosing days of LQT-1213 administered BID the last dosing day will have a single dose LQT-1213 will be administered BID on Days 2-4 Participants will be discharged from the CRU on Day 5 Approximately 7 days after discharge from the CRU the Follow-up Visit will be conducted remotely via telephone call
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None