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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-08-31

Study Completion Date

2007-11-30

Brief Summary

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

Detailed Description

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Conditions

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Healthy

Keywords

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Adult

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Lecozotan SR

Intervention Type DRUG

Citalopram

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Principal Investigators

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Medical Monitor

Role: STUDY_DIRECTOR

Wyeth is now a wholly owned subsidiary of Pfizer

Locations

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Manchester, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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3098B1-134

Identifier Type: -

Identifier Source: org_study_id