Healthy volunteers 246628
Study Dates: TBD - TBD
Trial Number
246628
Group
● Healthy Volunteer
● Smoking (No)
● Non-Childbearing Females
Compensation
$1,775
Gender
Male, Female, Non-Smoker
Age
18-55 years
BMI
18 -30 kg/m² For Part 1 and Part 2
13 -35 kg/m² For Part 3
Additional Information
Part 1
Six groups of eight healthy participants will receive a single oral dose of the study drug or matching placebo under fasted conditions.
Part 2
Part 2 includes a “high fat breakfast “*Cheese may replace Bacon for volunteers who are vegetarian.
Please ensure the participant does not have any dietary restrictions which would prevent them from completing the breakfast.
Part 3
Three groups of eight healthy participants will receive multiple oral doses of the study medicine per) or matching placebo under fed conditions.
For Part 3 we are looking to dose participants with a fasting serum LDL‑C ≥100 mg/dL (2.60 mmol/L) at the Screening Visit
Cohort 1a Admission 26th July to 31st July , outpatient visits 2nd and 4th August and follow up 11th August
Cohort 1b Admission 29th July to 3rd August , outpatient visits and 5th , 7th August and follow up 14th August
Details
The Sponsor is developing the medicine for treating dyslipidaemia (unhealthy levels of one or more kinds of lipid (fat) in your blood).
The main purpose of the trial is to see how safe the study medication is and how well it is tolerated after dosing .The trial will also investigate how the study medication is taken up, metabolised (chemically broken down), distributed through the body and excreted.
A further aim is to look at how this process is possibly altered by food by giving the study medication in the presence and absence of meals.
You will receive the study medication in the form of a capsule which you will swallow with a glass (240 mL) of water.
We are looking for healthy Males and non childbearing Females
This is a First into Human Study.