Chronic Pain
Conditions
Interventions
a single intravenous infusion of S-151128 or placebo
Sponsors
Gomez Juan Carlos
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion 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.
Exclusion criteria
Exclusion 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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | — |
Contacts
Public ContactCorporate Communications Department
Shionogi & Co., Ltd.
Outcome results
None listed