Manchester, United Kingdom
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.
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Notify MeKey information
Conditions
Age range
18 year–50 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 1
Primary location
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
DrugCitalopram
DrugPrimary outcomes
-
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.
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