Concentration-QT Study of Paroxetine in Healthy Adults

Status Completed

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Anxiety Disorders

Clinical Trial Details

NCT number	NCT06065735
Study type	Interventional
Source	GlaxoSmithKline
Contact
Status	Completed
Phase	Phase 1
Start date	October 2, 2023
Completion date	January 8, 2024

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