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

• Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00538889
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Duration (Months): 3
• Patients Per Site Per Month: 13.2

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: Lecozotan SR; Drug: Citalopram	Phase 1

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double
• Primary Purpose: Treatment
• Official Title: Combined Administration of Lecozotan SR and Citalopram: a Double Blind, Multiple Dose Study in Young Healthy Subjects
• Study Start Date: Aug 1, 2007
• Actual Study Completion Date: Nov 1, 2007

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 50 Years
• Sexes Eligible for Study: 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:

• 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Manchester		United Kingdom

Sponsors and Collaborators

• Wyeth is now a wholly owned subsidiary of Pfizer

Investigators

• Study Director: Medical Monitor, Wyeth is now a wholly owned subsidiary of Pfizer

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00538889
• Other Study ID Numbers: 3098B1-134
• First Posted: Oct 3, 2007
• Last Update Posted: Dec 11, 2007
• Last Verified: Dec 1, 2007

• Keywords provided by , ,: Adult
• Additional relevant MeSH terms: Citalopram

Study Results

No Results Posted as of Dec 11, 2007