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

Last updated on August 9, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Overland Park, Kansas, 66211 United States
Contact
1-800-718-1021
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

NCT00547014
Pfizer
Completed
First Safety Study in Humans of a Single Dose of CPG 52364

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[email protected]

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First Safety Study in Humans of a Single Dose of CPG 52364
Oral Administration Of CPG 52364 In Healthy Subjects: A Phase 1, Within-Cohort Randomized, Double-Blinded, Placebo-Controlled, Ascending Single-Dose, Single-Center Study
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.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Healthy Volunteers
  • 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
  • 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
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
61
April 2008
Not Provided

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
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00547014
B1221001
52364-002
No
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
March 2009

ICMJE     Data element required by the

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

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



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