Status:
WITHDRAWN
A Study of Soticlestat in Healthy Adults To Evaluate the Effect on QTc Interval
Lead Sponsor:
Takeda
Conditions:
Healthy Volunteers
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
The main aim is to see if soticlestat has any effect in the heart rate. Participants will receive 4 doses of soticlestat in tablets and will complete some assessment which include to record activity ...
Detailed Description
The drug being tested in this study is called soticlestat. Soticlestat is being tested in healthy participants for the purpose of this study. This study will assess the effect of single-dose of soticl...
Eligibility Criteria
Inclusion
- Male participants agree to comply with any applicable contraceptive requirements of the protocol.
- Body mass index (BMI) greater than or equal to (\>=)18.0 and \<=32.0 kilogram per square meter (kg/m\^2) at screening.
- Continuous non-smoker who has not used nicotine-containing products for at least 90 days prior to the first dosing, based on participant self-reporting.
- No clinically significant history or presence of ECG findings as judged by the Investigator or designee, including each criterion as listed below:
- Normal sinus rhythm (HR between 45 bpm and 100 bpm inclusive) at screening and check-in;
- QTcF is \<=450 ms (males) or \<=470 ms (females) at screening and check-in;
- QRS interval \<=110 ms; if \>110 ms, result will be confirmed by a manual over read at screening and check-in;
- PR interval \<=220 ms at screening and check-in.
Exclusion
- Mentally or legally incapacitated or has significant emotional problems at the time of the screening visit or expected during the conduct of the study.
- History or presence of any of the following, deemed clinically significant by the Investigator or designee:
- epilepsy, seizure, or convulsion, tremor or related symptoms;
- risk factors for Torsade de Pointes (TdP) (example, heart failure, unexplained syncope, cardiomyopathy, or family history of Long QT Syndrome);
- family history of sudden death;
- sick sinus syndrome, second or third degree atrioventricular block, myocardial infarction, pulmonary congestion, symptomatic or significant cardiac arrhythmia, prolonged QTcF interval, or conduction abnormalities;
- ischemic heart disease, poorly controlled hypertension, or other cardiovascular disorder;
- T wave flattening or other abnormalities which in the opinion of the investigator or designee may interfere with the analysis of QT intervals;
- clinically significant hyper- or hypokalemia.
- Any positive responses on the Columbia-Suicide Severity Rating Scale (C-SSRS) that in the clinical judgement of the Investigator has a risk of suicide or has made a suicide attempt in the previous 12 months prior to the first dosing.
- Positive urine drug or alcohol results at screening or at check-in.
- Positive results at screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or antibody test for hepatitis C virus (HCV).
- Unable to refrain from or anticipates the use of:
- Any vaccines, drugs, including prescription and non-prescription medications, herbal remedies, or vitamin supplements within 14 days prior to the first dosing. Thyroid hormone replacement medication may be permitted if the participant has been on the same stable dose for the immediate 3 months prior to first dosing.
- Any drugs known to be significant inducers of cytochrome P450 (CYP)3A, CYP2C19, uridine 5' diphospho-glucuronosyltransferase (UGT)1A9 or (UGT)2B4 enzymes and/or P-glycoprotein (P-gp), including St. John's Wort, within 28 days prior to the first dosing. Appropriate sources (example, Flockhart TableTM) will be consulted to confirm lack of Pharmacokinetics (PK)/pharmacodynamics interaction with study drug.
- Consumes excessive amounts, defined as greater than 4 servings (1 serving is approximately equivalent to 120 mg of caffeine) of coffee, tea, cola, energy drinks or other caffeinated beverages per day.
Key Trial Info
Start Date :
October 11 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 6 2022
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT05309902
Start Date
October 11 2022
End Date
December 6 2022
Last Update
November 14 2022
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