Phase 1 Study of LQT-1213 in Healthy Adults

NCT ID: NCT05759962

Last Updated: 2023-09-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-14
• Study Completion Date: 2023-03-05

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

LQT-1213

Intervention Type: DRUG

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

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.

Group Type: EXPERIMENTAL

LQT-1213

Intervention Type: DRUG

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

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.

Group Type: EXPERIMENTAL

LQT-1213

Intervention Type: DRUG

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

Part A: Single Ascending Dose (SAD) Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Matching 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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Matching 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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Matching Placebo

Interventions

LQT-1213

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

Intervention Type: DRUG

Placebo

Matching Placebo

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Thryv Therapeutics, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Altasciences Clinical Los Angeles, Inc.

Cypress, California, United States

Countries

United States

Other Identifiers

LQT-1213-0059

Identifier Type: -

Identifier Source: org_study_id