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COMPLETED
NCT06065735
PHASE1

Concentration-QT Study of Paroxetine in Healthy Adults

Sponsor: GlaxoSmithKline

View on ClinicalTrials.gov

Summary

The primary purpose of the study is to evaluate the potential effect of paroxetine on QTc interval following escalating doses in healthy participants. Participants with no history of cardiac abnormalities or mood disorders will be enrolled. During the study, participants will take paroxetine at three incremental dose levels. Participants will attend the clinic at screening, baseline, at the end of each dose level administration week, and a final study exit visit. While on treatment outside of clinic visits, participants will be followed-up via video-call. A concentration-QTc analysis will assess any potential correlation between paroxetine plasma concentration and QTc prolongation. In addition, the occurrence of any side-effects will be compared between on and off treatment.

Official title: An Open-Label, Single Arm, Dose Escalating Concentration-QT Study to Investigate the Cardiac Effects and Safety of Paroxetine in Healthy Adult Participants

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

38

Start Date

2023-10-02

Completion Date

2024-01-08

Last Updated

2026-08-19

Healthy Volunteers

Yes

Interventions

DRUG

Paroxetine

Paroxetine will be administered

Locations (1)

GSK Investigational Site

London, United Kingdom