Multiple Dose Study in Healthy Volunteers to Assess Safety, Pharmacokinetics and Pharmacodynamics of PF 03882845

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NCT00856258

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Study Location
Pfizer Investigational Site
New Haven, Connecticut, 06511, United States
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Contact
1-800-718-1021
[email protected]
Related Links

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]

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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
18-55 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Healthy male and female subjects of non-childbearing potential between the ages of 18 and 55 years, inclusive. Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12 lead ECG and clinical laboratory tests.

- An informed consent document signed and dated by the subject or a legally acceptable representative.

- Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.

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


- Evidence or history of clinically significant disease, allergy or clinical findings at
screening.


- A positive urine drug screen, history of significant regular alcohol consumption
within 6 months of screening or use of tobacco or nicotine containing products within
the three months preceding study date or a positive urine cotinine at screening or Day
-3.


- Blood donation of approximately 1 pint (500 mL) within 56 days prior to dosing.


- Pregnant or nursing females; females of childbearing potential.

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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]

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Advanced Information
Descriptive Information
Brief Title  ICMJE Multiple Dose Study in Healthy Volunteers to Assess Safety, Pharmacokinetics and Pharmacodynamics of PF 03882845
Official Title  ICMJE A Phase 1, Double Blind (Sponsor Open), Randomized, Placebo Controlled, Parallel Group, Oral Multiple Dose Trial To Evaluate The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Of PF 03882845 In Healthy Volunteers
Brief Summary To demonstrate the safety, pharmacokinetics and pharmacodynamics of drug candidate.
Detailed Description The study was terminated on June 19, 2009. Decision to terminate was based on Cohort 1 related safety concerns. An alternative clinical design was envisaged to better assess the benefit to risk.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Condition  ICMJE Healthy Volunteers
Intervention  ICMJE
  • Drug: PF 03882845 and Placebo
    The constituted dosage form for all doses were suspensions of drug candidate. Doses were administered once daily for 10 consecutive days.
  • Drug: PF 03882845 and Placebo
    The constituted dosage form for all doses will be suspensions of drug candidate. Doses will be once daily for 10 consecutive days.
Study Arms  ICMJE
  • Placebo Comparator: Cohort 1
    Cohort 1 completed.
    Intervention: Drug: PF 03882845 and Placebo
  • Placebo Comparator: Cohort 2
    Cohort 2 not studied
    Intervention: Drug: PF 03882845 and Placebo
  • Placebo Comparator: Cohort 3
    Cohort 3 not studied
    Intervention: Drug: PF 03882845 and Placebo
  • Placebo Comparator: Cohort 4
    Cohort 4 not studied
    Intervention: Drug: PF 03882845 and Placebo
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 Terminated
Actual Enrollment  ICMJE
 (submitted: December 9, 2009)		10
Original Estimated Enrollment  ICMJE
 (submitted: March 3, 2009)		40
Actual Study Completion Date  ICMJE June 2009
Actual Primary Completion Date June 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy male and female subjects of non-childbearing potential between the ages of 18 and 55 years, inclusive. Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12 lead ECG and clinical laboratory tests.
  • An informed consent document signed and dated by the subject or a legally acceptable representative.
  • Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.

Exclusion Criteria:

  • Evidence or history of clinically significant disease, allergy or clinical findings at screening.
  • A positive urine drug screen, history of significant regular alcohol consumption within 6 months of screening or use of tobacco or nicotine containing products within the three months preceding study date or a positive urine cotinine at screening or Day -3.
  • Blood donation of approximately 1 pint (500 mL) within 56 days prior to dosing.
  • Pregnant or nursing females; females of childbearing potential.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 55 Years   (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 NCT00856258
Other Study ID Numbers  ICMJE B0171002
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 December 2009

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