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

NCT00538889

Last updated date
Study Location
Manchester, , , United Kingdom
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-50 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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.

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Advanced Information
Descriptive Information
Brief Title  ICMJE Study Evaluating a Combined Administration of Lecozotan SR and Citalopram in Young Healthy Subjects
Official Title  ICMJE Combined Administration of Lecozotan SR and Citalopram: a Double Blind, Multiple Dose Study in Young Healthy Subjects
Brief Summary To assess the safety and tolerability of lecozotan SR and citalopram when coadministred to healthy subjects.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Healthy
Intervention  ICMJE
  • Drug: Lecozotan SR
  • Drug: Citalopram
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: October 2, 2007)
40
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 2007
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00538889
Other Study ID Numbers  ICMJE 3098B1-134
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Wyeth is now a wholly owned subsidiary of Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Medical MonitorWyeth is now a wholly owned subsidiary of Pfizer
PRS Account Wyeth is now a wholly owned subsidiary of Pfizer
Verification Date December 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP