Skip to main content
OpenTrials
Completed

NCT Number: NCT00538889

Study Evaluating a Combined Administration of Lecozotan SR and Citalopram in Young Healthy Subjects

To assess the safety and tolerability of lecozotan SR and citalopram when coadministred to healthy subjects.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Manchester, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Signed and dated IRB/IEC-approved informed consent form before any study-specific screening procedures are performed.
  • Men or women aged 18 to 50 years, inclusive, at screening.
  • Women of nonchildbearing potential, defined as being surgically sterile or postmenopausal for > 1 year, may be included. For women below 50 years of age, at least two years of retrospective amenorrhea and FSH>38 and estrogen <20 are required.
  • Body mass index (BMI) in the range of 18.0 to 30.0 kg/m2 and body weight greater than or equal to 50 kg. BMI is calculated by taking the subject's weight, in kilograms, divided by the square of the subject's average height, in meters, at screening: BMI = weight (kg)/(height [m])2

Exclusion criteria

  • Presence or history of any disorder that may prevent the successful completion of the study.
  • Any clinically important deviation from normal limits in physical examination, vital signs, 12-lead ECGs, or clinical laboratory test results.
  • Hypersensitivity to citalopram or any of the inactive ingredients in citalopram.

Treatment and study plan

Lecozotan SR

Drug

Citalopram

Drug

Primary outcomes

  1. Evaluation of 5-HT toxicity (Hunter serotonin toxicity criteria) and CNS questionnaires.

Sponsors and collaborators

Lead sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Industry

Registry information

Official study title

Combined Administration of Lecozotan SR and Citalopram: a Double Blind, Multiple Dose Study in Young Healthy Subjects

Important dates

Study start
2007
Study completion
2007
First posted
Oct 3, 2007
Registry last updated
Dec 11, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.