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A Single Dose PK Study of SENS-218 in Healthy Volunteers

NCT02772796 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2016-05-16

No results posted yet for this study

Summary

This study is to aid the development for the use of SENS-218 outside its marketed therapeutic indications. SENS-218 is available in Asia 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.

The study only involves the one drug, referred to as 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 pharmacokinetic (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.

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 visit to final end of study visit).

Conditions

  • Inner Ear Diseases

Interventions

DRUG

SENS-218

Oral Administration

Sponsors & Collaborators

  • Sensorion SA

    collaborator UNKNOWN

  • Simbec Research

    lead INDUSTRY

Principal Investigators

  • Girish Sharma, MBBS · Simbec Research

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-02-29
Primary Completion
2016-03-31
Completion
2016-03-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02772796 on ClinicalTrials.gov