Phase 1 Study of LQT-1213 in Healthy Adults

Long QT Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05759962
• Other study ID #: LQT-1213-0059
• Status: Completed
• Phase: Phase 1
• Start date: September 14, 2022
• Est. completion date: March 5, 2023

Study information

• Verified date: September 2023
• Source: Thryv Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: March 5, 2023
• Est. primary completion date: March 5, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Long QT Syndrome

Intervention

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

Other:
• Placebo
Matching Placebo

Locations

Country	Name	City	State
United States	Altasciences Clinical Los Angeles, Inc.	Cypress	California

Sponsors (1)

Lead Sponsor	Collaborator
Thryv Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Plasma Pharmacokinetics of LQT-1213: Tlag	Initial plasma concentration lag time	Part A SAD: Serially on Day 1; Part A Food Effect: Serially on Day 1 and Day 8
Secondary	Plasma Pharmacokinetics of LQT-1213: Cmax	Maximum observed plasma drug concentration	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
Secondary	Plasma Pharmacokinetics of LQT-1213: Tmax	Time to maximum observed plasma drug concentration	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
Secondary	Plasma Pharmacokinetics of LQT-1213: T1/2	Terminal phase half-life	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
Secondary	Plasma Pharmacokinetics of LQT-1213: AUC0-12, AUC0-T, and AUC0-8=	Area under the plasma drug concentration versus time curve	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
Secondary	Plasma Pharmacokinetics of LQT-1213: CL/F	Clearance, parent only	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
Secondary	Plasma Pharmacokinetics of LQT-1213: Vz/F	Volume of distribution, parent only	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
Secondary	Plasma Pharmacokinetics of LQT-1213: ?z	Terminal elimination rate constant	Part A SAD: Serially on Day 1; Part A Food Effect: Serially on Day 1 and Day 8
Secondary	Urine Pharmacokinetics of LQT-1213: Ae	Amount of the administered dose recovered over the entire 24-hour interval	Part A SAD and Food Effect: Serially on Day 1; Part B MAD: Serially on Days 1, 2, 7 and 8
Secondary	Urine Pharmacokinetics of LQT-1213: Ae0-t	Amount excreted unchanged in urine over a given time interval	Part A SAD and Food Effect: Serially on Day 1; Part B MAD: Serially on Days 1, 2, 7 and 8
Secondary	Urine Pharmacokinetics of LQT-1213: Fe	Percentage of the administered dose recovered over the entire 24-hour interval	Part A SAD and Food Effect: Serially on Day 1; Part B MAD: Serially on Days 1, 2, 7 and 8
Secondary	Urine Pharmacokinetics of LQT-1213: Fe/F	Fraction of dose excreted in urine	Part A SAD and Food Effect: Serially on Day 1; Part B MAD: Serially on Days 1, 2, 7 and 8
Secondary	Urine Pharmacokinetics of LQT-1213: CLR	Renal clearance Ae0-t/AUC0-t	Part A SAD and Food Effect: Serially on Day 1; Part B MAD: Serially on Days 1, 2, 7 and 8
Secondary	Plasma Pharmacokinetics of LQT-1213: Ctrough	Concentration of drug in the blood immediately before the next dose is administered	Part B MAD: Days 3-6
Secondary	Plasma Pharmacokinetics of LQT-1213: Cmin	Minimum observed plasma drug concentration	Part B MAD: Day 7
Secondary	Plasma Pharmacokinetics of LQT-1213: AUC0-tau, AUC0-T, and AUC0-8	Area under the plasma drug concentration versus time curve	Part B MAD: Day 7
Secondary	Plasma Pharmacokinetics of LQT-1213: CL/Fss	Clearance, parent only	Part B MAD: Day 7
Secondary	Plasma Pharmacokinetics of LQT-1213: Vz/Fss	Volume of Distribution, parent only	Part B MAD: Day 7
Secondary	Plasma Pharmacokinetics of LQT-1213: Rac(AUC) and Rac(Cmax)	Drug accumulation ratio	Part B MAD: Day 7