A single dose PK study of SENS-218 in healthly volunteers
Research type
Research Study
Full title
An open-label, single-dose, pharmacokinetic study of SENS-218 in healthy adult, Caucasian subjects
IRAS ID
193693
Contact name
Girish Sharma
Contact email
Sponsor organisation
Sensorion SA
Eudract number
2015-004580-36
Duration of Study in the UK
0 years, 1 months, 1 days
Research summary
This study is to aid the development for the use of SENS-218 outside its marketed therapeutic indications. SENS-218 has been available in Japan and is marketed as an anti-emetic (Anti-sickness) drug often prescribed after exposure to chemotherapy. Chemotherapy exposure can often induce nausea and/or vomiting. \n\nThe study only involves SENS-218 in this study. The purpose of the study is to support the development of use of SENS-218 in non-Asian population. The key objective of this study is to identify the pharamcokinetic (PK) parameters of the drug in healthy Caucasian population. The PK refers to what the body does to the body, for example, how quickly the drug is absorbed into the blood stream. \n\nThe population who are eligible to take part in the study are healthy male and female, non-smoking volunteers, aged between 18 and 50 years,as determined by screening tests at Simbec.\n\nParticipation in the trial will last for about 3 weeks (from first screening visit to final end of study visit). \n
REC name
Wales REC 1
REC reference
15/WA/0394
Date of REC Opinion
8 Dec 2015
REC opinion
Further Information Favourable Opinion