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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.