Comparative Formulation Study of Vabicaserin

Back to Search
Print
Bookmark Trial

NCT00928551

Last updated date
Back to Search
Print
Bookmark Trial
FOR MORE INFORMATION
Study Location
Brighton, Massachusetts, 2135, United States
See other locations
Contact
1-800-718-1021
[email protected]
Related Links

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

By phone

Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

Contact

[email protected]

Call Now

Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy Subjects
Sex
Male
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

- Sexually active men must agree to use a medically acceptable form of contraception during the study and continue it for 12 weeks after investigational product administration.

- Nonsmoker or smoker of fewer than 10 cigarettes per day as determined by history. Must be able to abstain from smoking during the inpatient stay.

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


- Use of any investigational or prescription drug within 30 days before investigation
product administration.


- Consumption of any caffeine-containing products (eg, coffee, tea, chocolate, or soda)
or alcoholic beverages within 48 hours before study day 1.


- Use of any over-the-counter drugs, including herbal supplements within 72 hours before
study day 1.

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

Call Now

TRY A NEW SEARCH

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.

Advanced Search

Based on your search, you may also be interested in

Healthy SubjectsPhase 1 Oral Solution and Crushed Tablet Relative Bioavailability Study of Apixaban When Administered Through a Nasogastric Tube in Healthy Subjects
NCT02034591
  1. San Antonio, Texas
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Healthy SubjectsTHE EFFECT OF CYP3A5 GENOTYPE ON THE PHARMACOKINETICS OF MARAVIROC
NCT02625207
  1. New Haven, Connecticut
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Healthy SubjectsA Trial Evaluating a 7-valent Pneumococcal Conjugate Vaccine Given With Diphtheria, Tetanus, and Acellular Pertussis Vaccine (DTaP) in Healthy Japanese Infants.
NCT01250756
  1. Isumi-city, Chiba
  2. Matsuyama-city, Ehime
  3. Itoshima, Fukuoka
  4. Kasuga, Fukuoka
  5. Sapporo-city, Hokkaido
  6. Sapporo, Hokkaido
  7. Sapporo, Hokkaido
  8. Sapporo, Hokkaido
  9. Kuwana, Mie
  10. Kurashiki, Okayama
  11. Okayama-city, Okayama
  12. Toyonaka, Osaka
  13. Kumagaya-city, Saitama
  14. Chiba,
  15. Fukuoka,
  16. Fukuoka,
  17. Fukuoka,
  18. Fukuoka,
ALL GENDERS
3 Months+
years
MULTIPLE SITES
Healthy SubjectsTrial Evaluating a 13-valent Pneumococcal Conjugate Vaccine Given With Diphtheria, Tetanus, and Acellular Pertussis Vaccine (DTaP) in Healthy Japanese Infants
NCT01200368
  1. Funabashi, Chiba
  2. Isumi-city, Chiba
  3. Matsuyama-city, Ehime
  4. Higashi-ku, Fukuoka-city, Fukuoka
  5. Fukuyama, Hiroshima
  6. Kure, Hiroshima
  7. Sapporo, Hokkaido
  8. Sapporo, Hokkaido
  9. Sapporo, Hokkaido
  10. Sapporo, Hokkaido
  11. Sapporo, Hokkaido
  12. Kikuchi-gun, Kumamoto
  13. Suzuka, MIE
  14. Tsu, MIE
  15. Tsu, MIE
  16. Kumagaya-city, Saitama
  17. Kumagaya, Saitama
  18. Fuchu, Tokyo
  19. Ota-ku, Tokyo
  20. Setagaya-ku, Tokyo
  21. Setagaya-ku, Tokyo
  22. Tachikawa-shi, Tokyo
  23. Tama, Tokyo
  24. Kofu, Yamanashi
  25. Koushu-shi, Yamanashi
  26. Tsuru-shi, Yamanashi
  27. Fukuoka,
  28. Fukuoka,
  29. Kumamoto,
  30. Kumamoto,
  31. Kumamoto,
  32. Okayama,
ALL GENDERS
3 Months+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Comparative Formulation Study of Vabicaserin
Official Title  ICMJE A Randomized, Open-Label, Single-Dose, 3-Period Crossover, Comparative Study of a Modified Formulation of Vabicaserin (SCA-136) Versus the Reference Formulation in Healthy Subjects
Brief Summary This study will compare two different formulations of vabicaserin.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Healthy Subjects
Intervention  ICMJE Drug: vabicaserin
Study Arms  ICMJE Experimental: 1
Intervention: Drug: vabicaserin
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: June 25, 2009)		15
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2009
Actual Primary Completion Date September 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Sexually active men must agree to use a medically acceptable form of contraception during the study and continue it for 12 weeks after investigational product administration.
  • Nonsmoker or smoker of fewer than 10 cigarettes per day as determined by history. Must be able to abstain from smoking during the inpatient stay.

Exclusion Criteria:

  • Use of any investigational or prescription drug within 30 days before investigation product administration.
  • Consumption of any caffeine-containing products (eg, coffee, tea, chocolate, or soda) or alcoholic beverages within 48 hours before study day 1.
  • Use of any over-the-counter drugs, including herbal supplements within 72 hours before study day 1.
Sex/Gender  ICMJE
Sexes Eligible for Study:Male
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 States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00928551
Other Study ID Numbers  ICMJE 3153B3-1128
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
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 September 2009

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