A study of SENS-401 when given for 7 days in a row to healthy subjects
Research type
Research Study
Full title
A randomised double blind, multiple dose, pharmacokinetic and safety study of SENS 401 in healthy subjects
IRAS ID
213413
Contact name
Girish Sharma
Contact email
Sponsor organisation
Sensorion SA
Eudract number
2016-003057-15
Duration of Study in the UK
0 years, 5 months, 8 days
Research summary
This study is to help development of a drug called SENS-401. SENS-401 is the R enantiomer of a Serotone® (SENS-218). Serotone® is a racemic mixture and is therefore composed of two enantiomers, the R enantiomer (SENS-401) and the S enantiomer. The enantiomers are structurally mirror images of each other, however, they cannot be superimposed Serotone® is available within Japan and has been marketed since 1994 as an anti-emetic (Anti-nausea/vomiting) drug, which is often prescribed after exposure to chemotherapy. Chemotherapy sometimes has side effects such as nausea and/or vomiting. This study is split into two cohorts of twelve subjects. It is placebo controlled study, whereby a total of 8 subjects will receive placebo and 16 will receive the active drug (SENS-401). The drug will be administered for a period of 7 days. The key objective is to assess the safety of SENS-401 and also to analyse the pharmacokinetic (PK) parameters of the drug. The PK parameters will include seeing how quickly the drug is absorbed into the blood stream. The 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. Participation in the trial will last for about 5 weeks (from first screening visit to final end of study visit).
REC name
Wales REC 1
REC reference
16/WA/0246
Date of REC Opinion
12 Sep 2016
REC opinion
Further Information Favourable Opinion