Phase 1 Study of LQT-1213 in Healthy Adults
Long QT Syndrome
About this trial
This is an interventional other trial for Long QT Syndrome focused on measuring LQT-1213, Congenital Long QT Syndrome, LQTS, Serum glucocorticoid regulated kinase-1, SGK-1 inhibitor
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
Sites / Locations
- Altasciences Clinical Los Angeles, Inc.
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Experimental
Experimental
Experimental
Placebo Comparator
Placebo Comparator
Placebo Comparator
Part A: Single Ascending Dose (SAD) LQT-1213
Part A: Food Effect LQT-1213
Part B: Multiple Ascending Dose (MAD) LQT-1213
Part A: Single Ascending Dose (SAD) Placebo
Part A: Food Effect Placebo
Part B: Multiple Ascending Dose (MAD) Placebo
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.
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.
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.
In Part A, 6 dosing cohorts will receive a single oral dose of 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.
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.