NCT06065735

Concentration-QT Study of Paroxetine in Healthy Adults

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Anxiety Disorders

Interventions

Type	Name	Description
DRUG	Paroxetine	Paroxetine will be administered

Timeline

• Start date: 2023-10-02
• Primary completion: 2024-01-08
• Completion: 2024-01-08
• First posted: 2023-10-04
• Last updated: 2024-12-16
• Results posted: 2024-12-16

Locations

1 site across 1 country: United Kingdom