Clinical Trials/NCT05759962

NCT05759962

Completed

Phase 1

A Phase 1, Randomized, Double-blinded, Placebo-controlled, Single and Multiple Ascending Dose Study to Evaluated the Safety, Tolerability, Pharmacokinetics, Food Effect, and Pharmacodynamics of LQT-1213 in Healthy Adult Participants

Thryv Therapeutics, Inc.1 site in 1 country50 target enrollmentSeptember 14, 2022

ConditionsLong QT Syndrome

InterventionsLQT-1213 Placebo

DrugsLQT-1213

Overview

Phase: Phase 1
Intervention: LQT-1213
Conditions: Long QT Syndrome
Sponsor: Thryv Therapeutics, Inc.
Enrollment: 50
Locations: 1
Primary Endpoint: Safety and Tolerability: Number of Participants with Adverse Events
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This is a single-center, randomized, double-blind, placebo-controlled study to be conducted in 2 parts: single ascending dose (SAD) incorporating a food effect arm and multiple ascending dose (MAD). Potential participants for each part will undergo screening procedures within 28 days of enrollment.

Registry

clinicaltrials.gov

Start Date

September 14, 2022

End Date

March 5, 2023

Last Updated

2 years ago

Study Type

Interventional

Study Design

Sequential

Sex

All

Investigators

Sponsor

Thryv Therapeutics, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Healthy adult male or female participants
•Females of childbearing potential must agree and commit to use an adequate form of contraception.
•Men who are biologically capable of fathering children must agree and commit to use an adequate form of contraception.
•Aged at least 18 years but not older than 60 years (inclusive)
•Body mass index (BMI) within 18.0 kg/m\^2 to 32.0 kg/m\^2, inclusively.
•Non- or ex-smoker
•Have no clinically significant diseases captured in the medical history or evidence of clinically significant findings on the physical examination (including vital signs) and/or ECG, as determined by an investigator.

Exclusion Criteria

•Clinically significant diseases or any other condition, which, in the opinion of the Investigator, would jeopardize the safety of the participant or impact the validity of the study results.
•Clinically significant abnormal findings on the physical examination or medical history during screening as deemed by the principal investigator
•Female who is lactating
•Female who is pregnant
•Male participants with a history of oligospermia or azoospermia or any other disorder of the reproductive system
•Male participants who are undergoing treatment or evaluation for infertility.
•History of significant hypersensitivity to LQT-1213, kinase inhibitors or any related products (including excipients of the formulations) as well as severe hypersensitivity reactions (like angioedema) to any drugs
•Use of immunosuppressant in the 28 days prior to the first study drug administration
•Maintenance therapy with any drug or significant history of drug dependency or alcohol abuse (\> 3 units of alcohol per day, intake of excessive alcohol, acute or chronic)
•Intake of an investigational product or participation in a clinical trial in the 90 days prior to the first study drug administration

Arms & Interventions

Part A: Single Ascending Dose (SAD) LQT-1213

In Part A, 4 dosing cohorts will receive a single oral dose of LQT-1213. The highest dose of LQT-1213 to be administered is 1.67 mg/kg.

Intervention: LQT-1213

Part A: Food Effect LQT-1213

In Part A, food effect will be integrated into one of the SAD cohorts as a single dose, two-period with at least a 7-day washout, crossover cohort.

Intervention: LQT-1213

Part B: Multiple Ascending Dose (MAD) LQT-1213

In Part B, 3 dosing cohorts will receive LQT-1213 in the morning on Day 1 and Day 7 and twice daily (BID) on Days 2 to 6.

Intervention: LQT-1213

Part A: Single Ascending Dose (SAD) Placebo

In Part A, 6 dosing cohorts will receive a single oral dose of placebo.

Intervention: Placebo

Part A: Food Effect Placebo

In Part A, food effect will be integrated into one of the SAD cohorts as a single dose, two-period with at least a 7-day washout, crossover cohort.

Intervention: Placebo

Part B: Multiple Ascending Dose (MAD) Placebo

In Part B, 3 dosing cohorts will receive placebo in the morning on Day 1 and Day 7 and twice daily (BID) on Days 2 to 6.

Intervention: Placebo

Outcomes

Primary Outcomes

Safety and Tolerability: Number of Participants with Adverse Events

Time Frame: Part A SAD: Day 7; Part A Food Effect: Day 15; Part B MAD: Day 16

Number of Participants with Adverse Events

Secondary Outcomes

Plasma Pharmacokinetics of LQT-1213: T1/2(Part A SAD: Serially on Day 1; Part A Food Effect: Serially on Day 1 and Day 8; Part B MAD: Serially on Day 1 and 7)
Urine Pharmacokinetics of LQT-1213: Ae0-t(Part A SAD and Food Effect: Serially on Day 1; Part B MAD: Serially on Days 1, 2, 7 and 8)
Plasma Pharmacokinetics of LQT-1213: Cmax(Part A SAD: Serially on Day 1; Part A Food Effect: Serially on Day 1 and Day 8; Part B MAD: Serially on Day 1 and 7)
Plasma Pharmacokinetics of LQT-1213: AUC0-12, AUC0-T, and AUC0-∞=(Part A SAD: Serially on Day 1; Part A Food Effect: Serially on Day 1 and Day 8; Part B MAD: Serially on Day 1)
Plasma Pharmacokinetics of LQT-1213: λz(Part A SAD: Serially on Day 1; Part A Food Effect: Serially on Day 1 and Day 8)
Urine Pharmacokinetics of LQT-1213: Ae(Part A SAD and Food Effect: Serially on Day 1; Part B MAD: Serially on Days 1, 2, 7 and 8)
Plasma Pharmacokinetics of LQT-1213: Tlag(Part A SAD: Serially on Day 1; Part A Food Effect: Serially on Day 1 and Day 8)
Plasma Pharmacokinetics of LQT-1213: Tmax(Part A SAD: Serially on Day 1; Part A Food Effect: Serially on Day 1 and Day 8; Part B MAD: Serially on Day 1)
Urine Pharmacokinetics of LQT-1213: CLR(Part A SAD and Food Effect: Serially on Day 1; Part B MAD: Serially on Days 1, 2, 7 and 8)
Plasma Pharmacokinetics of LQT-1213: Ctrough(Part B MAD: Days 3-6)
Plasma Pharmacokinetics of LQT-1213: CL/F(Part A SAD: Serially on Day 1; Part A Food Effect: Serially on Day 1 and Day 8; Part B MAD: Serially on Day 1)
Plasma Pharmacokinetics of LQT-1213: Vz/F(Part A SAD: Serially on Day 1; Part A Food Effect: Serially on Day 1 and Day 8; Part B MAD: Serially on Day 1)
Urine Pharmacokinetics of LQT-1213: Fe(Part A SAD and Food Effect: Serially on Day 1; Part B MAD: Serially on Days 1, 2, 7 and 8)
Urine Pharmacokinetics of LQT-1213: Fe/F(Part A SAD and Food Effect: Serially on Day 1; Part B MAD: Serially on Days 1, 2, 7 and 8)
Plasma Pharmacokinetics of LQT-1213: Cmin(Part B MAD: Day 7)
Plasma Pharmacokinetics of LQT-1213: Vz/Fss(Part B MAD: Day 7)
Plasma Pharmacokinetics of LQT-1213: AUC0-tau, AUC0-T, and AUC0-∞(Part B MAD: Day 7)
Plasma Pharmacokinetics of LQT-1213: CL/Fss(Part B MAD: Day 7)
Plasma Pharmacokinetics of LQT-1213: Rac(AUC) and Rac(Cmax)(Part B MAD: Day 7)