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Trial record 1 of 1 for:    NCT00550381
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Study Evaluating the Safety, Tolerability, and Pharmacokinetics (PK) of HKI-357 Administered Orally to Healthy Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00550381
Recruitment Status : Completed
First Posted : October 29, 2007
Last Update Posted : July 10, 2009
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer

Tracking Information
First Submitted Date  ICMJE October 26, 2007
First Posted Date  ICMJE October 29, 2007
Last Update Posted Date July 10, 2009
Study Start Date  ICMJE January 2008
Actual Primary Completion Date March 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 21, 2007)
Safety, tolerability, PK [ Time Frame: 5 days ]
Original Primary Outcome Measures  ICMJE
 (submitted: October 26, 2007)
Safety, tolerability, PK
Change History Complete list of historical versions of study NCT00550381 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study Evaluating the Safety, Tolerability, and Pharmacokinetics (PK) of HKI-357 Administered Orally to Healthy Subjects
Official Title  ICMJE Ascending Single-Dose Study of the Safety, Tolerability, and Pharmacokinetics of HKI-357 Administered Orally to Healthy Subjects
Brief Summary The purpose of this study is to assess the safety, tolerability, and pharmacokinetics of single doses of HKI-357 administered to 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
Intervention  ICMJE Drug: HKI-357
Single-dose capsule
Study Arms  ICMJE
  • Placebo Comparator: 1
    10mg
    Intervention: Drug: HKI-357
  • Placebo Comparator: 2
    20mg
    Intervention: Drug: HKI-357
  • Placebo Comparator: 3
    40mg
    Intervention: Drug: HKI-357
  • Placebo Comparator: 4
    80mg
    Intervention: Drug: HKI-357
  • Placebo Comparator: 5
    160mg
    Intervention: Drug: HKI-357
  • Placebo Comparator: 6
    240mg
    Intervention: Drug: HKI-357
  • Placebo Comparator: 7
    400mg
    Intervention: Drug: HKI-357
  • Placebo Comparator: 8
    640mg
    Intervention: Drug: HKI-357
  • Placebo Comparator: 9
    960mg
    Intervention: Drug: HKI-357
  • Placebo Comparator: 10
    placebo
    Intervention: Drug: HKI-357
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 26, 2007)
72
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2008
Actual Primary Completion Date March 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Eligibility Criteria:

  • Healthy adult men or women of nonchildbearing potential, aged 18-50.
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 Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00550381
Other Study ID Numbers  ICMJE 3235A1-1000
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 Monitor Wyeth 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