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Study Evaluating the Safety, Tolerability, and Pharmacokinetics (PK) of HKI-357 Administered Orally to Healthy Subjects

Last updated on November 11, 2019

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Study Location
Contact
1-800-718-1021
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.
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Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
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NCT00550381
Pfizer
Completed
Study Evaluating the Safety, Tolerability, and Pharmacokinetics (PK) of HKI-357 Administered Orally to Healthy Subjects

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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 SummaryThe purpose of this study is to assess the safety, tolerability, and pharmacokinetics of single doses of HKI-357 administered to healthy subjects.
Detailed DescriptionNot 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 DateMarch 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 CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyWyeth (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 AccountWyeth is now a wholly owned subsidiary of Pfizer
Verification DateJuly 2009

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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