Altasciences Clinical Los Angeles, Inc.
Cypress, California, 90630, United States
NCT Number: NCT05759962
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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Notify Me18 year–60 year
All sexes
Interventional
Phase 1
Cypress, California, 90630, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Key Inclusion Criteria:
Exclusion criteria
LQT-1213 is a serum glucocorticoid regulated kinase 1 (SGK-1) inhibitor
Matching Placebo
Time frame: Part A SAD: Day 7; Part A Food Effect: Day 15; Part B MAD: Day 16
Number of Participants with Adverse Events
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
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
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
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
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
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
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
Time frame: Part A SAD: Serially on Day 1; Part A Food Effect: Serially on Day 1 and Day 8
Terminal elimination rate constant
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
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
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
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
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
Time frame: Part B MAD: Days 3-6
Concentration of drug in the blood immediately before the next dose is administered
Time frame: Part B MAD: Day 7
Minimum observed plasma drug concentration
Time frame: Part B MAD: Day 7
Area under the plasma drug concentration versus time curve
Time frame: Part B MAD: Day 7
Clearance, parent only
Time frame: Part B MAD: Day 7
Volume of Distribution, parent only
Time frame: Part B MAD: Day 7
Drug accumulation ratio
Thryv Therapeutics, Inc.
Industry
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
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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