Study Evaluating the Safety, Pharmacokinetics (PK), and Pharmacodynamices (PD) of HSD-016

NCT00838461

Last updated date
Study Location
Chula Vista, California, 91911, United States
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.
Healthy Subjects
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

1. Men or women of nonchildbearing potential aged 18 to 50 years.

2. Healthy as determined by investigator on the basis of medical history and physical examination, laboratory test results, and 12-lead ECG. 3. Nonsmoker or smoker of fewer than 10 cigarettes per day.

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


1. No history of thyroid abnormalities.


2. No presence or history of any disorder that may prevent the successful completion of
the study.


3. No history of drug abuse.


4. No use of any systemic steroids for 3 months.


5. No history of claustrophobia.

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

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
Healthy SubjectsStudy Evaluating the Safety, Pharmacokinetics (PK), and Pharmacodynamices (PD) of HSD-016 NCT00838461
  1. Chula Vista, California
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Healthy SubjectsStudy Evaluating The Mass Balance And Metabolic Disposition Of SKI-606 NCT00757341
  1. Tacoma, Washington
Male
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Study Evaluating the Safety, Pharmacokinetics (PK), and Pharmacodynamices (PD) of HSD-016
Official Title  ICMJE Multiple Ascending Dose Study of the Safety, Pharmacokinetics, and Pharmacodynamics of HSD-016 Administered Orally to Healthy Subjects
Brief Summary This is intended to provide an initial safety assessment of HSD-016 and also to evaluate how the drug is absorbed and eliminated and its effect on the body in healthy subjects.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Healthy Subjects
Intervention  ICMJE
  • Drug: HSD-016
  • Drug: placebo
Study Arms  ICMJE
  • Active Comparator: 1
    HSD-016
    Intervention: Drug: HSD-016
  • Placebo Comparator: 2
    placebo
    Intervention: Drug: placebo
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: February 5, 2009)
32
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2009
Actual Primary Completion Date June 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion criteria:

  1. Men or women of nonchildbearing potential aged 18 to 50 years.
  2. Healthy as determined by investigator on the basis of medical history and physical examination, laboratory test results, and 12-lead ECG. 3. Nonsmoker or smoker of fewer than 10 cigarettes per day.

Exclusion criteria:

  1. No history of thyroid abnormalities.
  2. No presence or history of any disorder that may prevent the successful completion of the study.
  3. No history of drug abuse.
  4. No use of any systemic steroids for 3 months.
  5. No history of claustrophobia.
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 States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00838461
Other Study ID Numbers  ICMJE 3248A1-1002
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 July 2009

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