Phase 1 single-dose study of S-151128

JRCT ID: jRCT2031230023

Registered date:16/04/2023

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Chronic Pain
• Date of first enrollment: 22/04/2023
• Target sample size: 64
• Study type: Interventional
• Intervention(s): a single intravenous infusion of S-151128 or placebo

Outcome(s)

• Primary Outcome: 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

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 55age old
• Gender: Both

Include criteria

-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.

Exclude criteria

-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).

Related Information

• Primary Sponsor: Gomez Juan Carlos