Phase 1 single-dose study of S-151128
- Conditions
- Chronic Pain
- Registration Number
- JPRN-jRCT2031230023
- Lead Sponsor
- Gomez Juan Carlos
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 64
Aged 18 to 55 years, inclusive, at the time of informed consent.
-Apparently healthy in the opinion of the investigator at screening and on admission.
-Having Japanese parents.
-Systolic blood pressure at rest falling outside the range of 90 to 140 mmHg or diastolic blood pressure falling outside the range of 50 to 90 mmHg, or pulse rate falling outside the range of 50 to 90 bpm at screening or admission and are considered ineligible for this study by the investigator.
-Current or a history of syncope of unknown cause, sick sinus syndrome, second or third degree atrioventricular block, myocardial infarction, pulmonary congestion, arrhythmia, angina pectoris, QT interval prolonged, or conduction abnormality.
-Current or a history of risk factors for Torsade de Pointes (eg, cardiac failure, cardiomyopathy, hypokalemia, family history of long QT syndrome, Brugada syndrome).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Adverse events, laboratory tests (hematology, blood chemistry, and urinalysis), vital signs (systolic/diastolic blood pressure, body temperature, pulse rate, respiratory rate, and SpO2), 12-lead ECG (HR, PR, QRS, QT, RR, QTcF), Holter ECG, Schellong test, heat perception test (warm detection threshold, heat pain threshold), hand bath test, standard pure tone audiometry, and questionnaire on sense of smell and taste
- Secondary Outcome Measures
Name Time Method