Clinical Trial: A Single Dose PK Study of SENS-218 in Healthy Volunteers
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: An Open-label, Single-dose, Pharmacokinetic Study of SENS-218 in Healthy Adult, Caucasian Subjects.
Brief 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).
Detailed Summary:
This study consists of a screening visit, 1 treatment period and a post study visit.
These are outlined below:
Screening visit ( Day -14 to Day -1)
- Ensure subjects are eligible for the study.
Treatment period 1 -If all screening assessments are satisfactory, subjects will be invited to attend Simbec to take part in the study. The treatment period consists of 2 overnight stays (Day -1 until the morning of Day 2). One return visit is required at the 48 hour point post dose on Day 3.
Post study visit
-Subjects will be asked to attend Simbec 5-7 days after administration of the last dose for a post study visit. If you are withdrawn from the study, you will still be asked to attend for an end of study assessment.
Subjects may be asked to return again if we need to follow you up.
Sponsor: Simbec Research
Current Primary Outcome:
- Cmax - Max plasma concentration of SENS-218 in healthy adults [ Time Frame: 0 to 48 hours. ]
- Tmax -Time taken to reach Cmax for SENS-218 in healthy adults [ Time Frame: 0 to 48 hours. ]
- kel - elimination rate constant of SENS-218 in healthy adults [ Time Frame: 0 to 48 hours. ]
- t1/2 - Terminal Elimination half life of SENS-218 in healthy adults [ Time Frame: 0 to 48 hours ]
- AUC0-t - area under the concentration-time curve (AUC) from the time of dosing to last measurable concentration of SENS-218 in healthy adults. [ Time Frame: 0 to 48 hours ]
- AUC0-inf - the AUC extrapolated to infinity of SENS-218 in healthy [ Time Frame: 0 to 48 hours ]
- CL/F - clearance, calculated as dose/AUC0-inf of SENS-218 in healthy adults. [ Time Frame: 0 to 48 hours ]
- MRT - Mean residence time of SENS-218 in healthy adults [ Time Frame: 0 to 48 hours ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- 12-lead ECGs [ Time Frame: Day 1 until post study (5 to 7 days following IMP administration) ]12-lead ECG assessments: Heart rate, PR interval, QRS width, QT interval and QT interval corrected using Bazett's formula (QTcB).
- Vitals signs [ Time Frame: Day 1 until post study (5 to 7 days following IMP administration) ]Vital signs assessments: Systolic/diastolic blood pressure and pulse rate and oral body temperature. corrected using Bazett's formula (QTcB).
- Physical examination [ Time Frame: Day 1 until post study (5 to 7 days following IMP administration) ]
Original Secondary Outcome: Same as current
Information By: Simbec Research
Dates:
Date Received: April 25, 2016
Date Started: February 2016
Date Completion:
Last Updated: May 11, 2016
Last Verified: May 2016
