drugset / Trial / NCT03071003

A Study of SENS 401 in Healthy Subjects

NCT03071003 ↗

Phase 1 Completed 36 enrolled Simbec Research Sensorion SA · collab
RandomizedSequentialDouble-blindBasic science

Summary

Sensorion are the study sponsor and the objective of this study is to investigate the safety and pharmacokinetic (PK) profile of SENS 401 in humans after a single and repeat dose administration and to confirm that, there is no interconversion of the (R) enantiomer to the (S) enantiomer. The study only involves the one drug, referred to as SENS-401.The key objective is to assess the safety of SENS 401 after multiple doses in healthy subjects. 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 3 weeks (from first screening to final end of study visit).

Timeline

Start
2016-10-21
Primary completion
2017-03-21
Completion
2017-10-16

Drugs

EvaluationDrugModalityDoseRoute
Subject SENS-401 Unknown 29 mg Oral
Subject SENS-401 Unknown 43.5 mg Oral

Indications