You are here

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

Last updated on November 14, 2019

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

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]

call now

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 Volunteers
NCT04092595
All Genders
18+
Years
Brussels, Be-bru
Adult, Drug Interactions, Healthy Volunteers, Humans
NCT03961997
All Genders
18+
Years
Brussels, Be-bru
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 SummaryDetermine 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 DescriptionNot 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 DateNot 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 CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyDirector, Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateMarch 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 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