First Safety Study in Humans of a Single Dose of CPG 52364

NCT00547014

Last updated date
Study Location
Pfizer Investigational Site
Overland Park, Kansas, 66211, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy Volunteers
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-65 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Normal body mass index and weight

- No significant diseases in the medical history or clinically significant findings on physical exam, opthalmologic exam, clinical laboratory evaluations or 12-lead electrocardiogram

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


- Current illness or history of medical condition affecting the body's function


- Use of any medication within 7 days, any immunosuppressive medication within 6 months,
any investigational drug within 30 days or any vaccine or immunoglobulin within 90
days


- Use of any medications during the study


- Positive TB test


- Smoking within 6 months


- Pregnancy or risk of Pregnancy


- Alcohol or drug misuse within 60 days


- Sensitivity to quinazolines

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Advanced Information
Descriptive Information
Brief Title  ICMJE First Safety Study in Humans of a Single Dose of CPG 52364
Official Title  ICMJE Oral Administration Of CPG 52364 In Healthy Subjects: A Phase 1, Within-Cohort Randomized, Double-Blinded, Placebo-Controlled, Ascending Single-Dose, Single-Center Study
Brief Summary Determine the safety and tolerability of the study drug, CPG 52364, when given as liquid or capsule. Another purpose is to determine how the drug enters and leaves the blood stream and body tissues over time.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Condition  ICMJE Healthy Volunteers
Intervention  ICMJE
  • Drug: Placebo Comparator: Cohort 1 Placebo
    Drug: placebo for cohort 1 as single dose
  • Drug: 52364 3 mg
    3 mg capsule single dose administered orally as a single dose
  • Drug: Placebo Comparator: Cohorts 2, 3, 4 & 5 Two subjects each arm will be assigned to receive placebo
    Drug: Placebo for cohorts 2, 3, 4 and 5 administered as a single dose
  • Drug: 52364 10 mg
    Drug: 52364 30 mg capsule as a single dose
  • Drug: 52364 30 mg
    Drug: 52364 30 mg capsule administered as a single dose
  • Drug: 52364 100 mg
    Drug 52364 100 mg capsule administered as a single dose
  • Drug: 52364 1 mg
    1 mg powder diluted in liquid or placebo (liquid alone) administered orally as a single dose
Study Arms  ICMJE
  • Experimental: Cohort 1 1mg
    Interventions:
    • Drug: Placebo Comparator: Cohort 1 Placebo
    • Drug: 52364 1 mg
  • Experimental: Cohort 2
    Interventions:
    • Drug: 52364 3 mg
    • Drug: Placebo Comparator: Cohorts 2, 3, 4 & 5 Two subjects each arm will be assigned to receive placebo
  • Experimental: Cohort 3
    Intervention: Drug: 52364 10 mg
  • Experimental: Cohort 4
    Intervention: Drug: 52364 30 mg
  • Experimental: Cohort 5
    Intervention: Drug: 52364 100 mg
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
Actual Enrollment  ICMJE
 (submitted: August 7, 2008)
61
Original Estimated Enrollment  ICMJE
 (submitted: October 18, 2007)
50
Actual Study Completion Date  ICMJE April 2008
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Normal body mass index and weight
  • No significant diseases in the medical history or clinically significant findings on physical exam, opthalmologic exam, clinical laboratory evaluations or 12-lead electrocardiogram

Exclusion Criteria:

  • Current illness or history of medical condition affecting the body's function
  • Use of any medication within 7 days, any immunosuppressive medication within 6 months, any investigational drug within 30 days or any vaccine or immunoglobulin within 90 days
  • Use of any medications during the study
  • Positive TB test
  • Smoking within 6 months
  • Pregnancy or risk of Pregnancy
  • Alcohol or drug misuse within 60 days
  • Sensitivity to quinazolines
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older 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 NCT00547014
Other Study ID Numbers  ICMJE B1221001
52364-002
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date March 2009

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