Concentration-QT Study of Paroxetine in Healthy Adults
Status:
Completed
Trial end date:
2024-01-08
Target enrollment:
Participant gender:
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.