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).
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 If you are withdrawn from the study, you will still be asked to attend for an end of study assessment.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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
24
Oral Administration
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
12-lead ECGs
12-lead ECG assessments: Heart rate, PR interval, QRS width, QT interval and QT interval corrected using Bazett's formula (QTcB).
Time frame: Day 1 until post study (5 to 7 days following IMP administration)
Vitals signs
Vital signs assessments: Systolic/diastolic blood pressure and pulse rate and oral body temperature. corrected using Bazett's formula (QTcB).
Time frame: Day 1 until post study (5 to 7 days following IMP administration)
Physical examination
Time frame: Day 1 until post study (5 to 7 days following IMP administration)
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