Phase 1 Study of LQT-1213 in Healthy Adults

Thryv Therapeutics, Inc.50 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

DOUBLE

Enrollment

Conditions

Long QT Syndrome

Interventions

LQT-1213DRUG

LQT-1213 is a serum glucocorticoid regulated kinase 1 (SGK-1) inhibitor

PlaceboOTHER

Matching Placebo

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

Key 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

Locations (1)

Altasciences Clinical Los Angeles, Inc.

Cypress, California, United States

Outcomes

Primary Outcomes

Safety and Tolerability: Number of Participants with Adverse Events

Number of Participants with Adverse Events

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

Secondary Outcomes

Plasma Pharmacokinetics of LQT-1213: Tlag

Initial plasma concentration lag time

Time frame: Part A SAD: Serially on Day 1; Part A Food Effect: Serially on Day 1 and Day 8

Plasma Pharmacokinetics of LQT-1213: Cmax

Maximum observed plasma drug concentration

Time frame: 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: Tmax

Time to maximum observed plasma drug concentration

Time frame: 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: T1/2

Terminal phase half-life

Time frame: 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-∞=

Area under the plasma drug concentration versus time curve

Time frame: 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: CL/F

Clearance, parent only

Time frame: 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

Data from ClinicalTrials.gov

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