NCT00538889

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P50-P75 for phase_1 healthy

Timeline
Completed

Started Aug 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2007

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 1, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 3, 2007

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2007

Completed
Last Updated

December 11, 2007

Status Verified

December 1, 2007

First QC Date

October 1, 2007

Last Update Submit

December 9, 2007

Conditions

Healthy

Keywords

Adult

Outcome Measures

Primary Outcomes (1)

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

Interventions

Lecozotan SRDRUG
CitalopramDRUG

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Manchester, United Kingdom

Location

MeSH Terms

Interventions

lecozotanCitalopram

Intervention Hierarchy (Ancestors)

PropylaminesAminesOrganic ChemicalsNitrilesBenzofuransHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Medical Monitor

    Wyeth is now a wholly owned subsidiary of Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 1, 2007

First Posted

October 3, 2007

Study Start

August 1, 2007

Study Completion

November 1, 2007

Last Updated

December 11, 2007

Record last verified: 2007-12

Locations

GB(1)