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Phase 1 Study of LQT-1213 in Healthy Adults

Primary Purpose

Long QT Syndrome

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
LQT-1213
Placebo
Sponsored by
Thryv Therapeutics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Long QT Syndrome focused on measuring LQT-1213, Congenital Long QT Syndrome, LQTS, Serum glucocorticoid regulated kinase-1, SGK-1 inhibitor

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Altasciences Clinical Los Angeles, Inc.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Placebo Comparator

Placebo Comparator

Arm Label

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

Part A: Food Effect LQT-1213

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

Part A: Single Ascending Dose (SAD) Placebo

Part A: Food Effect Placebo

Part B: Multiple Ascending Dose (MAD) Placebo

Arm 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.

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.

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.

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

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.

Outcomes

Primary Outcome Measures

Safety and Tolerability: Number of Participants with Adverse Events
Number of Participants with Adverse Events

Secondary Outcome Measures

Plasma Pharmacokinetics of LQT-1213: Tlag
Initial plasma concentration lag time
Plasma Pharmacokinetics of LQT-1213: Cmax
Maximum observed plasma drug concentration
Plasma Pharmacokinetics of LQT-1213: Tmax
Time to maximum observed plasma drug concentration
Plasma Pharmacokinetics of LQT-1213: T1/2
Terminal phase half-life
Plasma Pharmacokinetics of LQT-1213: AUC0-12, AUC0-T, and AUC0-∞=
Area under the plasma drug concentration versus time curve
Plasma Pharmacokinetics of LQT-1213: CL/F
Clearance, parent only
Plasma Pharmacokinetics of LQT-1213: Vz/F
Volume of distribution, parent only
Plasma Pharmacokinetics of LQT-1213: λz
Terminal elimination rate constant
Urine Pharmacokinetics of LQT-1213: Ae
Amount of the administered dose recovered over the entire 24-hour interval
Urine Pharmacokinetics of LQT-1213: Ae0-t
Amount excreted unchanged in urine over a given time interval
Urine Pharmacokinetics of LQT-1213: Fe
Percentage of the administered dose recovered over the entire 24-hour interval
Urine Pharmacokinetics of LQT-1213: Fe/F
Fraction of dose excreted in urine
Urine Pharmacokinetics of LQT-1213: CLR
Renal clearance Ae0-t/AUC0-t
Plasma Pharmacokinetics of LQT-1213: Ctrough
Concentration of drug in the blood immediately before the next dose is administered
Plasma Pharmacokinetics of LQT-1213: Cmin
Minimum observed plasma drug concentration
Plasma Pharmacokinetics of LQT-1213: AUC0-tau, AUC0-T, and AUC0-∞
Area under the plasma drug concentration versus time curve
Plasma Pharmacokinetics of LQT-1213: CL/Fss
Clearance, parent only
Plasma Pharmacokinetics of LQT-1213: Vz/Fss
Volume of Distribution, parent only
Plasma Pharmacokinetics of LQT-1213: Rac(AUC) and Rac(Cmax)
Drug accumulation ratio

Full Information

First Posted
January 4, 2023
Last Updated
September 25, 2023
Sponsor
Thryv Therapeutics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05759962
Brief Title
Phase 1 Study of LQT-1213 in Healthy Adults
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
September 14, 2022 (Actual)
Primary Completion Date
March 5, 2023 (Actual)
Study Completion Date
March 5, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Thryv Therapeutics, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Long QT Syndrome
Keywords
LQT-1213, Congenital Long QT Syndrome, LQTS, Serum glucocorticoid regulated kinase-1, SGK-1 inhibitor

7. Study Design

Primary Purpose
Other
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Part A: Single Ascending Dose (SAD) LQT-1213
Arm Type
Experimental
Arm 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.
Arm Title
Part A: Food Effect LQT-1213
Arm Type
Experimental
Arm 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.
Arm Title
Part B: Multiple Ascending Dose (MAD) LQT-1213
Arm Type
Experimental
Arm 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.
Arm Title
Part A: Single Ascending Dose (SAD) Placebo
Arm Type
Placebo Comparator
Arm Description
In Part A, 6 dosing cohorts will receive a single oral dose of placebo.
Arm Title
Part A: Food Effect Placebo
Arm Type
Placebo Comparator
Arm 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.
Arm Title
Part B: Multiple Ascending Dose (MAD) Placebo
Arm Type
Placebo Comparator
Arm 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.
Intervention Type
Drug
Intervention Name(s)
LQT-1213
Intervention Description
LQT-1213 is a serum glucocorticoid regulated kinase 1 (SGK-1) inhibitor
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Matching Placebo
Primary Outcome Measure Information:
Title
Safety and Tolerability: Number of Participants with Adverse Events
Description
Number of Participants with Adverse Events
Time Frame
Part A SAD: Day 7; Part A Food Effect: Day 15; Part B MAD: Day 16
Secondary Outcome Measure Information:
Title
Plasma Pharmacokinetics of LQT-1213: Tlag
Description
Initial plasma concentration lag time
Time Frame
Part A SAD: Serially on Day 1; Part A Food Effect: Serially on Day 1 and Day 8
Title
Plasma Pharmacokinetics of LQT-1213: Cmax
Description
Maximum observed plasma drug concentration
Time Frame
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
Title
Plasma Pharmacokinetics of LQT-1213: Tmax
Description
Time to maximum observed plasma drug concentration
Time Frame
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
Title
Plasma Pharmacokinetics of LQT-1213: T1/2
Description
Terminal phase half-life
Time Frame
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
Title
Plasma Pharmacokinetics of LQT-1213: AUC0-12, AUC0-T, and AUC0-∞=
Description
Area under the plasma drug concentration versus time curve
Time Frame
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
Title
Plasma Pharmacokinetics of LQT-1213: CL/F
Description
Clearance, parent only
Time Frame
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
Title
Plasma Pharmacokinetics of LQT-1213: Vz/F
Description
Volume of distribution, parent only
Time Frame
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
Title
Plasma Pharmacokinetics of LQT-1213: λz
Description
Terminal elimination rate constant
Time Frame
Part A SAD: Serially on Day 1; Part A Food Effect: Serially on Day 1 and Day 8
Title
Urine Pharmacokinetics of LQT-1213: Ae
Description
Amount of the administered dose recovered over the entire 24-hour interval
Time Frame
Part A SAD and Food Effect: Serially on Day 1; Part B MAD: Serially on Days 1, 2, 7 and 8
Title
Urine Pharmacokinetics of LQT-1213: Ae0-t
Description
Amount excreted unchanged in urine over a given time interval
Time Frame
Part A SAD and Food Effect: Serially on Day 1; Part B MAD: Serially on Days 1, 2, 7 and 8
Title
Urine Pharmacokinetics of LQT-1213: Fe
Description
Percentage of the administered dose recovered over the entire 24-hour interval
Time Frame
Part A SAD and Food Effect: Serially on Day 1; Part B MAD: Serially on Days 1, 2, 7 and 8
Title
Urine Pharmacokinetics of LQT-1213: Fe/F
Description
Fraction of dose excreted in urine
Time Frame
Part A SAD and Food Effect: Serially on Day 1; Part B MAD: Serially on Days 1, 2, 7 and 8
Title
Urine Pharmacokinetics of LQT-1213: CLR
Description
Renal clearance Ae0-t/AUC0-t
Time Frame
Part A SAD and Food Effect: Serially on Day 1; Part B MAD: Serially on Days 1, 2, 7 and 8
Title
Plasma Pharmacokinetics of LQT-1213: Ctrough
Description
Concentration of drug in the blood immediately before the next dose is administered
Time Frame
Part B MAD: Days 3-6
Title
Plasma Pharmacokinetics of LQT-1213: Cmin
Description
Minimum observed plasma drug concentration
Time Frame
Part B MAD: Day 7
Title
Plasma Pharmacokinetics of LQT-1213: AUC0-tau, AUC0-T, and AUC0-∞
Description
Area under the plasma drug concentration versus time curve
Time Frame
Part B MAD: Day 7
Title
Plasma Pharmacokinetics of LQT-1213: CL/Fss
Description
Clearance, parent only
Time Frame
Part B MAD: Day 7
Title
Plasma Pharmacokinetics of LQT-1213: Vz/Fss
Description
Volume of Distribution, parent only
Time Frame
Part B MAD: Day 7
Title
Plasma Pharmacokinetics of LQT-1213: Rac(AUC) and Rac(Cmax)
Description
Drug accumulation ratio
Time Frame
Part B MAD: Day 7

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Facility Information:
Facility Name
Altasciences Clinical Los Angeles, Inc.
City
Cypress
State/Province
California
ZIP/Postal Code
90630
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Phase 1 Study of LQT-1213 in Healthy Adults

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