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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05759962
Other study ID # LQT-1213-0059
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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