Safety, PK and PD Study in Healthy Male Japanese Subjects

NCT00447941

Last updated date
Contact
1-800-718-1021

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.
Schizophrenia
Sex
Male
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
20-45 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Men aged 20 to 45 years at the time of obtaining informed consent.

- Body mass index (BMI) in the range of 18.5 to 25.0 kg/m2 and body weight ≥ 50 kg.

- Healthy as determined by the investigator on the basis of medical history, physical examination, clinical laboratory test results, vital signs, and 12-lead electrocardiogram (ECG).

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 significant cardiovascular, hepatic, renal, respiratory, gastrointestinal,
endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease.


- Any surgical or medical condition that may interfere with the absorption,
distribution, metabolism, or excretion (ADME) of the test article (eg, resection of
liver, kidney, or gastrointestinal tract).

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]

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.

Based on your search, you may also be interested in

SchizophreniaStudy Evaluating the Effects of Multiple Doses of NSA-789 in Subjects With Schizophrenia or Schizoaffective Disorder
NCT00892021
  1. Rockville, Maryland
ALL GENDERS
18 Years+
years
MULTIPLE SITES
SchizophreniaLarge Simple Trial (LST) Of Cardiovascular Safety Of Ziprasidone And Olanzapine- (Zodiac)
NCT00418171
  1. San Bernardino, California
  2. Aiea, Hawaii
  3. Schaumburg, Illinois
  4. Grants Pass, Oregon
  5. Whitehall, West Virginia
ALL GENDERS
18 Years+
years
MULTIPLE SITES
SchizophreniaAn Outpatient Study Of The Efficacy, Safety, And Tolerability Of PF-02545920 In The Adjunctive Treatment Of Sub-Optimally Controlled Symptoms of Schizophrenia
NCT01939548
  1. Birmingham, Alabama
  2. Little Rock, Arkansas
  3. Cerritos, California
  4. Culver City, California
  5. Escondido, California
  6. Garden Grove, California
  7. Oakland, California
  8. Oceanside, California
  9. Orange, California
  10. Riverside, California
  11. San Diego, California
  12. San Diego, California
  13. Torrance, California
  14. Hartford, Connecticut
  15. Hartford, Connecticut
  16. New Haven, Connecticut
  17. Washington, District of Columbia
  18. Bradenton, Florida
  19. Brandenton, Florida
  20. Lauderhill, Florida
  21. Sanford, Florida
  22. Atlanta, Georgia
  23. Hoffman Estates, Illinois
  24. Hoffman Estates, Illinois
  25. Schaumburg, Illinois
  26. Lake Charles, Louisiana
  27. Shreveport, Louisiana
  28. Rockville, Maryland
  29. O'Fallon, Missouri
  30. St. Louis, Missouri
  31. Las Vegas, Nevada
  32. Jamaica, New York
  33. New York, New York
  34. Ward's Island, New York
  35. Dayton, Ohio
  36. Oklahoma City, Oklahoma
  37. Memphis, Tennessee
  38. Austin, Texas
  39. Austin, Texas
  40. Dallas, Texas
  41. Dallas, Texas
  42. DeSoto, Texas
  43. Salt Lake City, Utah
  44. Salt Lake City, Utah
ALL GENDERS
18 Years+
years
MULTIPLE SITES
SchizophreniaAn Inpatient Study Of The Efficacy, Safety, And Tolerability Of PF-02545920 In The Treatment Of Acute Exacerbation Of Schizophrenia
NCT01175135
  1. Little Rock, Arkansas
  2. Anaheim, California
  3. Escondido, California
  4. Escondido, California
  5. Garden Grove, California
  6. Long Beach, California
  7. Long Beach, California
  8. Orange, California
  9. Paramount, California
  10. Paramount, California
  11. San Diego, California
  12. Santa Ana, California
  13. Torrance, California
  14. Torrance, California
  15. Washington, District of Columbia
  16. Bradenton, Florida
  17. Maitland, Florida
  18. Orlando, Florida
  19. Atlanta, Georgia
  20. Hoffman Estates, Illinois
  21. Hoffman Estates, Illinois
  22. Hoffman Estates, Illinois
  23. Lake Charles, Louisiana
  24. Lake Charles, Louisiana
  25. Rockville, Maryland
  26. Saint Louis, Missouri
  27. Willingboro, New Jersey
  28. Willingboro, New Jersey
  29. Hollis, New York
  30. Philadelphia, Pennsylvania
  31. Austin, Texas
  32. Austin, Texas
  33. Austin, Texas
  34. DeSoto, Texas
  35. Houston, Texas
  36. Houston, Texas
  37. Kirkland, Washington
  38. Kirkland, Washington
  39. Mannheim,
  40. Dnipropetrovsk,
  41. Dnipropetrovsk,
  42. Kyiv,
  43. Kyiv,
  44. Lugansk,
  45. Poltava,
  46. Stepanivka, Kherson,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Safety, PK and PD Study in Healthy Male Japanese Subjects
Official Title  ICMJE Randomized, Double-blind, Placebo-controlled, Ascending Multiple Dose Study of the Safety, Pharmacokinetics, and Pharmacodynamics of Sca-136 Administered Orally to Healthy Male Japanese Subjects
Brief Summary Study assessing pharmacokinetics, pharmacodynamics, safety, and tolerability of oral doses of SCA-136 in healthy male Japanese subjects
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Schizophrenia
Intervention  ICMJE Drug: SCA-136
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
Enrollment  ICMJE
 (submitted: March 14, 2007)
24
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2006
Actual Primary Completion Date August 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria

  • Men aged 20 to 45 years at the time of obtaining informed consent.
  • Body mass index (BMI) in the range of 18.5 to 25.0 kg/m2 and body weight ? 50 kg.
  • Healthy as determined by the investigator on the basis of medical history, physical examination, clinical laboratory test results, vital signs, and 12-lead electrocardiogram (ECG).

Exclusion Criteria

  • Presence or history of any disorder that may prevent the successful completion of the study.
  • Any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease.
  • Any surgical or medical condition that may interfere with the absorption, distribution, metabolism, or excretion (ADME) of the test article (eg, resection of liver, kidney, or gastrointestinal tract).
Sex/Gender  ICMJE
Sexes Eligible for Study:Male
Ages  ICMJE 20 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00447941
Other Study ID Numbers  ICMJE 3153A1-103
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 August 2009

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