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Concentration-QT Study of Paroxetine in Healthy Adults | Clinical Trials | Clareo Health

COMPLETEDPHASE1

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

NCT06065735•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.

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Participants, both male and female, aged between 18 to 65 years, at the time of signing the informed consent.
•Participants determined as healthy based on medical evaluation by an experienced physician.
•A female participant is eligible to participate if she is of:
•* Nonchildbearing potential defined as premenopausal females with a documented tubal ligation or hysterectomy; or postmenopausal defined as 12 months of spontaneous amenorrhea.
•* Child-bearing potential and agrees to use one of the contraception methods for an appropriate time as mentioned in the study protocol.
•Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), alkaline phosphatase, and bilirubin ≤ 1.5x (Upper Limit of Normal) ULN (isolated bilirubin \>1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin \<35%).
•Body weight ≥ 45 kilogram (kg) and Body Mass Index (BMI) within the range 18 to 29.5 kilogram per metre square (kg/m2) (inclusive).
•No significant abnormality on 12-lead Electrocardiogram (ECG) at Screening in supine position, including the following specific requirements:
•1. Heart rate ≥ 40 beats per minute
•2. PR interval ≤ 220 milliseconds (msec) (For PR, QRS and QTcF interval, and Q wave, the mean of triplicate ECGs will be used)
+6 more criteria

Exclusion Criteria

•History or presence of any medically significant disease that may cause additional risk or interfere with the study procedures or outcome.
•History of symptomatic arrhythmias.
•History of hypersensitivity to paroxetine and excipients
•History of abnormal coagulation parameters, bleeding disorders or conditions which may predispose to bleeding.
•History of, or active suicidal ideation. Includes assessment using the Columbia Suicide Severity Rating Scale (C-SSRS)
•Must not have a pre-diagnosed mood disorder
•Participant is mentally or legally incapacitated.
•A supine blood pressure that is persistently higher than 140/90 millimetres of mercury (mmHG) at Screening.
•A supine heart rate outside the range 50-90 beats per minute (bpm) at Screening.
•A positive screening Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening.
+15 more criteria

Locations (1)

GSK Investigational Site

London, United Kingdom

Key Dates

Start Date

October 2, 2023

Primary Completion Date

January 8, 2024

Completion Date

January 8, 2024

Last Updated

December 16, 2024

Enrollment

ACTUAL participants

Conditions

Anxiety Disorders

Interventions

Paroxetine

DRUG

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RECRUITINGNA

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 16, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Concentration-QT Study of Paroxetine in Healthy Adults

Inclusion Criteria

Exclusion Criteria

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