Phase 1 Study of LQT-1213 in Healthy Adults

September 25, 2023 updated by: Thryv Therapeutics, Inc.

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Cypress, California, United States, 90630
        • Altasciences Clinical Los Angeles, Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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.
Drug: LQT-1213
LQT-1213 is a serum glucocorticoid regulated kinase 1 (SGK-1) inhibitor
Experimental: 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.
Drug: LQT-1213
LQT-1213 is a serum glucocorticoid regulated kinase 1 (SGK-1) inhibitor
Experimental: 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.
Drug: LQT-1213
LQT-1213 is a serum glucocorticoid regulated kinase 1 (SGK-1) inhibitor
Placebo Comparator: Part A: Single Ascending Dose (SAD) Placebo
In Part A, 6 dosing cohorts will receive a single oral dose of placebo.
Other: Placebo
Matching Placebo
Placebo Comparator: 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.
Other: Placebo
Matching Placebo
Placebo Comparator: 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.
Other: Placebo
Matching Placebo

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Safety and Tolerability: Number of Participants with Adverse Events
Time Frame: Part A SAD: Day 7; Part A Food Effect: Day 15; Part B MAD: Day 16
Number of Participants with Adverse Events
Part A SAD: Day 7; Part A Food Effect: Day 15; Part B MAD: Day 16

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Plasma Pharmacokinetics of LQT-1213: Tlag
Time Frame: Part A SAD: Serially on Day 1; Part A Food Effect: Serially on Day 1 and Day 8
Initial plasma concentration lag time
Part A SAD: Serially on Day 1; Part A Food Effect: Serially on Day 1 and Day 8
Plasma Pharmacokinetics of LQT-1213: Cmax
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
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
Plasma Pharmacokinetics of LQT-1213: Tmax
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
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
Plasma Pharmacokinetics of LQT-1213: T1/2
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
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
Plasma Pharmacokinetics of LQT-1213: AUC0-12, AUC0-T, and AUC0-∞=
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
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
Plasma Pharmacokinetics of LQT-1213: CL/F
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
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
Plasma Pharmacokinetics of LQT-1213: Vz/F
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
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
Plasma Pharmacokinetics of LQT-1213: λz
Time Frame: Part A SAD: Serially on Day 1; Part A Food Effect: Serially on Day 1 and Day 8
Terminal elimination rate constant
Part A SAD: Serially on Day 1; Part A Food Effect: Serially on Day 1 and Day 8
Urine Pharmacokinetics of LQT-1213: Ae
Time Frame: Part A SAD and Food Effect: Serially on Day 1; Part B MAD: Serially on Days 1, 2, 7 and 8
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
Urine Pharmacokinetics of LQT-1213: Ae0-t
Time Frame: Part A SAD and Food Effect: Serially on Day 1; Part B MAD: Serially on Days 1, 2, 7 and 8
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
Urine Pharmacokinetics of LQT-1213: Fe
Time Frame: Part A SAD and Food Effect: Serially on Day 1; Part B MAD: Serially on Days 1, 2, 7 and 8
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
Urine Pharmacokinetics of LQT-1213: Fe/F
Time Frame: Part A SAD and Food Effect: Serially on Day 1; Part B MAD: Serially on Days 1, 2, 7 and 8
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
Urine Pharmacokinetics of LQT-1213: CLR
Time Frame: Part A SAD and Food Effect: Serially on Day 1; Part B MAD: Serially on Days 1, 2, 7 and 8
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
Plasma Pharmacokinetics of LQT-1213: Ctrough
Time Frame: Part B MAD: Days 3-6
Concentration of drug in the blood immediately before the next dose is administered
Part B MAD: Days 3-6
Plasma Pharmacokinetics of LQT-1213: Cmin
Time Frame: Part B MAD: Day 7
Minimum observed plasma drug concentration
Part B MAD: Day 7
Plasma Pharmacokinetics of LQT-1213: AUC0-tau, AUC0-T, and AUC0-∞
Time Frame: Part B MAD: Day 7
Area under the plasma drug concentration versus time curve
Part B MAD: Day 7
Plasma Pharmacokinetics of LQT-1213: CL/Fss
Time Frame: Part B MAD: Day 7
Clearance, parent only
Part B MAD: Day 7
Plasma Pharmacokinetics of LQT-1213: Vz/Fss
Time Frame: Part B MAD: Day 7
Volume of Distribution, parent only
Part B MAD: Day 7
Plasma Pharmacokinetics of LQT-1213: Rac(AUC) and Rac(Cmax)
Time Frame: Part B MAD: Day 7
Drug accumulation ratio
Part B MAD: Day 7

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Thryv Therapeutics, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 14, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 5, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 5, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 4, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 7, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 8, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 26, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 25, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • LQT-1213-0059

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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