Healthy
Conditions
Keywords
Adult
Brief summary
To assess the safety and tolerability of lecozotan SR and citalopram when coadministred to healthy subjects.
Interventions
DRUGLecozotan SR
DRUGCitalopram
Sponsors
Wyeth is now a wholly owned subsidiary of Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
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
* 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluation of 5-HT toxicity (Hunter serotonin toxicity criteria) and CNS questionnaires. | — |
Countries
United Kingdom
Outcome results
None listed