Clinical trial NCT05759962: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Long QT Syndrome
Keywords: LQT-1213
Congenital Long QT Syndrome
LQTS
Serum glucocorticoid regulated kinase-1
SGK-1 inhibitor
Lead sponsor: Thryv Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2023-03-08
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: OTHER

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.


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

Primary outcomes:
measure: Safety and Tolerability: Number of Participants with Adverse Events
timeFrame: Part A SAD: Day 7; Part A Food Effect: Day 15; Part B MAD: Day 16
Secondary outcomes:
measure: Plasma Pharmacokinetics of LQT-1213: Tlag
timeFrame: Part A SAD: Serially on Day 1; Part A Food Effect: Serially on Day 1 and Day 8
measure: Plasma Pharmacokinetics of LQT-1213: Cmax
timeFrame: 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
measure: Plasma Pharmacokinetics of LQT-1213: Tmax
timeFrame: 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
measure: Plasma Pharmacokinetics of LQT-1213: T1/2
timeFrame: 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
measure: Plasma Pharmacokinetics of LQT-1213: AUC0-12, AUC0-T, and AUC0-∞=
timeFrame: 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
measure: Plasma Pharmacokinetics of LQT-1213: CL/F
timeFrame: 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
measure: Plasma Pharmacokinetics of LQT-1213: Vz/F
timeFrame: 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
measure: Plasma Pharmacokinetics of LQT-1213: λz
timeFrame: Part A SAD: Serially on Day 1; Part A Food Effect: Serially on Day 1 and Day 8
measure: Urine Pharmacokinetics of LQT-1213: Ae
timeFrame: Part A SAD and Food Effect: Serially on Day 1; Part B MAD: Serially on Days 1, 2, 7 and 8
measure: Urine Pharmacokinetics of LQT-1213: Ae0-t
timeFrame: Part A SAD and Food Effect: Serially on Day 1; Part B MAD: Serially on Days 1, 2, 7 and 8
measure: Urine Pharmacokinetics of LQT-1213: Fe
timeFrame: Part A SAD and Food Effect: Serially on Day 1; Part B MAD: Serially on Days 1, 2, 7 and 8
measure: Urine Pharmacokinetics of LQT-1213: Fe/F
timeFrame: Part A SAD and Food Effect: Serially on Day 1; Part B MAD: Serially on Days 1, 2, 7 and 8
measure: Urine Pharmacokinetics of LQT-1213: CLR
timeFrame: Part A SAD and Food Effect: Serially on Day 1; Part B MAD: Serially on Days 1, 2, 7 and 8
measure: Plasma Pharmacokinetics of LQT-1213: Ctrough
timeFrame: Part B MAD: Days 3-6
measure: Plasma Pharmacokinetics of LQT-1213: Cmin
timeFrame: Part B MAD: Day 7
measure: Plasma Pharmacokinetics of LQT-1213: AUC0-tau, AUC0-T, and AUC0-∞
timeFrame: Part B MAD: Day 7
measure: Plasma Pharmacokinetics of LQT-1213: CL/Fss
timeFrame: Part B MAD: Day 7
measure: Plasma Pharmacokinetics of LQT-1213: Vz/Fss
timeFrame: Part B MAD: Day 7
measure: Plasma Pharmacokinetics of LQT-1213: Rac(AUC) and Rac(Cmax)
timeFrame: Part B MAD: Day 7
Other outcomes:
Locations:
city: Cypress
country: United States
facility: Altasciences Clinical Los Angeles, Inc.
state: California
Study officials:
References: