Phase 1 Study of LQT-1213 in Healthy Adults

NCT05759962 | Completed Phase 1 FDA Drug

• 1 other identifier: LQT-1213-0059
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Long QT Syndrome

Keywords

LQT-1213; Congenital Long QT Syndrome; LQTS; Serum glucocorticoid regulated kinase-1; SGK-1 inhibitor

Outcome Measures

Primary Outcomes (1)

• Safety and Tolerability: Number of Participants with Adverse Events

  Number of Participants with Adverse Events

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

Secondary Outcomes (19)

• 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: 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: 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

• 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

• 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

Study Arms (6)

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

EXPERIMENTAL

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.

Drug: LQT-1213

Part A: Food Effect LQT-1213

EXPERIMENTAL

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.

Drug: LQT-1213

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

EXPERIMENTAL

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.

Drug: LQT-1213

Part A: Single Ascending Dose (SAD) Placebo

PLACEBO COMPARATOR

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

Other: Placebo

Part A: Food Effect Placebo

PLACEBO COMPARATOR

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.

Other: Placebo

Part B: Multiple Ascending Dose (MAD) Placebo

PLACEBO COMPARATOR

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.

Other: Placebo

Interventions

LQT-1213 DRUG

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

Part A: Food Effect LQT-1213; Part A: Single Ascending Dose (SAD) LQT-1213; Part B: Multiple Ascending Dose (MAD) LQT-1213

Placebo OTHER

Matching Placebo

Part A: Food Effect Placebo; Part A: Single Ascending Dose (SAD) Placebo; Part B: Multiple Ascending Dose (MAD) Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Thryv Therapeutics, Inc.: lead

Study Sites (1)

Altasciences Clinical Los Angeles, Inc.

Cypress, California, 90630, United States

Location

MeSH Terms

Conditions

Long QT Syndrome

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Heart Defects, Congenital; Cardiovascular Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2023
• First Posted: March 8, 2023
• Study Start: September 14, 2022
• Primary Completion: March 5, 2023
• Study Completion: March 5, 2023
• Last Updated: September 26, 2023

Record last verified: 2023-09

Locations

US (1)