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OpenTrials
Completed

NCT Number: NCT05759962

Phase 1 Study of LQT-1213 in Healthy Adults

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Altasciences Clinical Los Angeles, Inc.

Cypress, California, 90630, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LQT-1213

Drug

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

Placebo

Other

Matching Placebo

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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

  15. Plasma Pharmacokinetics of LQT-1213: Cmin

    Time frame: Part B MAD: Day 7

    Minimum observed plasma drug concentration

  16. 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

  17. Plasma Pharmacokinetics of LQT-1213: CL/Fss

    Time frame: Part B MAD: Day 7

    Clearance, parent only

  18. Plasma Pharmacokinetics of LQT-1213: Vz/Fss

    Time frame: Part B MAD: Day 7

    Volume of Distribution, parent only

  19. Plasma Pharmacokinetics of LQT-1213: Rac(AUC) and Rac(Cmax)

    Time frame: Part B MAD: Day 7

    Drug accumulation ratio

Sponsors and collaborators

Lead sponsor

Thryv Therapeutics, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Mar 8, 2023
Registry last updated
Sep 26, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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