Phase 1 Study of LQT-1213 in Healthy Adults
- Registration Number
- NCT05759962
- Lead Sponsor
- Thryv Therapeutics, Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 50
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
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Part A: Food Effect LQT-1213 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. Part A: Single Ascending Dose (SAD) LQT-1213 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. Part B: Multiple Ascending Dose (MAD) LQT-1213 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. Part A: Single Ascending Dose (SAD) Placebo Placebo In Part A, 6 dosing cohorts will receive a single oral dose of placebo. Part A: Food Effect Placebo 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. Part B: Multiple Ascending Dose (MAD) Placebo 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.
- Primary Outcome Measures
Name Time Method Safety and Tolerability: Number of Participants with Adverse Events Part A SAD: Day 7; Part A Food Effect: Day 15; Part B MAD: Day 16 Number of Participants with Adverse Events
- Secondary Outcome Measures
Name Time Method Plasma Pharmacokinetics of LQT-1213: T1/2 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
Urine Pharmacokinetics of LQT-1213: Ae0-t 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
Plasma Pharmacokinetics of LQT-1213: Cmax 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
Plasma Pharmacokinetics of LQT-1213: AUC0-12, AUC0-T, and AUC0-∞= 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
Plasma Pharmacokinetics of LQT-1213: λz Part A SAD: Serially on Day 1; Part A Food Effect: Serially on Day 1 and Day 8 Terminal elimination rate constant
Urine Pharmacokinetics of LQT-1213: Ae 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
Plasma Pharmacokinetics of LQT-1213: Tlag Part A SAD: Serially on Day 1; Part A Food Effect: Serially on Day 1 and Day 8 Initial plasma concentration lag time
Plasma Pharmacokinetics of LQT-1213: Tmax 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
Urine Pharmacokinetics of LQT-1213: CLR 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
Plasma Pharmacokinetics of LQT-1213: Ctrough Part B MAD: Days 3-6 Concentration of drug in the blood immediately before the next dose is administered
Plasma Pharmacokinetics of LQT-1213: CL/F 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
Plasma Pharmacokinetics of LQT-1213: Vz/F 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
Urine Pharmacokinetics of LQT-1213: Fe 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
Urine Pharmacokinetics of LQT-1213: Fe/F 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
Plasma Pharmacokinetics of LQT-1213: Cmin Part B MAD: Day 7 Minimum observed plasma drug concentration
Plasma Pharmacokinetics of LQT-1213: Vz/Fss Part B MAD: Day 7 Volume of Distribution, parent only
Plasma Pharmacokinetics of LQT-1213: AUC0-tau, AUC0-T, and AUC0-∞ Part B MAD: Day 7 Area under the plasma drug concentration versus time curve
Plasma Pharmacokinetics of LQT-1213: CL/Fss Part B MAD: Day 7 Clearance, parent only
Plasma Pharmacokinetics of LQT-1213: Rac(AUC) and Rac(Cmax) Part B MAD: Day 7 Drug accumulation ratio
Trial Locations
- Locations (1)
Altasciences Clinical Los Angeles, Inc.
🇺🇸Cypress, California, United States