LE16061 Healthy Volunteer Trial

LE16061 Healthy Volunteer Trial

CONDITION

GENDER

Both males and females

AGE GROUP

18 years to 65 years

TRIAL STATUS

Closed: follow-up complete

A Phase 1, Single-Center, Open-label Study to Evaluate the Safety and Pharmacokinetics of Two Tablet Formulations of PRN1008.

The purpose of this study is to investigate the relative bioavailability (the proportion of the study drug which enters the circulation) of PRN1008 when administered as two different tablet formulations – one that is immediate release (IR) and one that has a coating that delays release of the study drug. Participants in this study will receive 3 doses of the delayed release (DR) tablet formulation and 1 dose of the immediate release formulation.

Eligible participants will be required to stay in the clinical unit for a total of 4 study periods consisting of 2 confinement periods. The length of involvement would be up to 76 days (this includes a 4 week screening period, one confinement period of 2 ½ day with 2 overnight stays, a 28 day gap period, then a second confinement period of 8 ½ days with 8 overnight stays and a follow-up visit up to 9 days after your last dose of study drug).

Participants must meet the following criteria:

Male or Female between the ages of 18 and 65
BMI must be between 18 – 35 kg/m2
Medication free with no allergies to any drugs
Non-smokers within last 6 months
Free from any clinically significant illness or disease as determined by medical history

Remuneration is offered to eligible participants.

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CONTACT DETAILS

Phone Number: 0863825100
Email: contactus@linear.org.au
Location: Hospital Avenue, Nedlands, Western Australia, Australia

CONTACT SITE

Approved By: HREC              

Clinical Trial Registry Link: