Concentration-QT Study of Paroxetine in Healthy Adults
Research type
Research Study
Full title
An Open-Label, Single Arm, Dose Escalating Concentration-QT Study to Investigate the Cardiac Effects and Safety of Paroxetine in Healthy Adult Participants
IRAS ID
1007867
Contact name
Sanman Ghorpade
Contact email
Sponsor organisation
GlaxoSmithKline Research & Development Limited
Research summary
This is a clinical study sponsored by GSK, the study will include healthy volunteers (males and females) between the age of 18 to 65yrs recruited in the UK. Study design involves open label, nonrandomized, single centre, safety evaluation. There will be up to 8 subjects per cohort, with 4 cohorts planned. The participant involvement will last up to 11 weeks for each participant.
The study drug under evaluation is paroxetine, it is given to treat psychiatric conditions such as major depressive disorder, obsessive compulsive disorder, panic disorder, social and generalised anxiety disorders, and post-traumatic stress disorder in adults. This drug has been approved for use in the UK
The study is designed to evaluate the effect of paroxetine on the heart (cardiac effects) at increasing plasma concentration levels.
The trial will comprise of:
• Screening period of a maximum 28 days i.e. -28Day to Day1
• Dosing period up to 31 days, dosing to begin with 20mg increased in a gradient manner up to 60mg & tapered to mitigate withdrawal effects if any
• During the dosing period there will be a minimum of 4 clinic stays ranging up to 3 days and 2 nights
• Followed by approximately 24 daily video calls with study staff between clinic visits. The purpose of this is for doctor/ study staff to evaluate wellbeing, supervise home dosing & study design provisions additional visits based on volunteer & investigator needs
• A follow up visit after 14 days from last dose to ensure overall healthREC name
London - Harrow Research Ethics Committee
REC reference
23/LO/0409
Date of REC Opinion
26 Sep 2023
REC opinion
Further Information Favourable Opinion