Phase 1 Study of LQT-1213 in Healthy Adults

Thryv Therapeutics

Status and phase: Completed; Phase 1

Conditions: Long QT Syndrome

Treatments: Drug: LQT-1213; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT05759962

LQT-1213-0059

Details and patient eligibility

About

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.

Enrollment: 50 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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50 participants in 6 patient groups, including a placebo group

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

Experimental group

Description:

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.

Treatment:

Drug: LQT-1213

Part A: Food Effect LQT-1213

Experimental group

Description:

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.

Treatment:

Drug: LQT-1213

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

Experimental group

Description:

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.

Treatment:

Drug: LQT-1213

Part A: Single Ascending Dose (SAD) Placebo

Placebo Comparator group

Description:

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

Treatment:

Other: Placebo

Part A: Food Effect Placebo

Placebo Comparator group

Description:

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.

Treatment:

Other: Placebo

Part B: Multiple Ascending Dose (MAD) Placebo

Placebo Comparator group

Description:

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.

Treatment:

Other: Placebo