CClinicalTrials.gg
CompletedNCT00538889Updated Dec 11, 2007

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

A Phase 1 interventional study of Lecozotan SR and Citalopram in Healthy, sponsored by Wyeth is now a wholly owned subsidiary of Pfizer. Completed at 1 site in United Kingdom. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2007-12-11.

Sponsored by Wyeth is now a wholly owned subsidiary of Pfizer · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Healthy

Keywords

  • Adult
03

In context

Lead sponsor

Wyeth is now a wholly owned subsidiary of Pfizer is the lead sponsor of 472 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double
Enrollment
40 participants (estimated)

Interventions

  • DrugLecozotan SR
  • DrugCitalopram
06

What researchers measure

Primary outcomes

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

07

Study locations

1 site
  • Manchester, United Kingdom
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 11, 2007, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00538889
Lead sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
First posted
Oct 3, 2007
Start date
Aug 2007
Completion
Nov 2007
Last update
Dec 11, 2007

Study contacts

Medical Monitor
study director · Wyeth is now a wholly owned subsidiary of Pfizer
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2007. You cannot join it, but the record below documents what was studied.

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