Safety and Tolerability of PF-06818883 in Healthy Subjects

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NCT03020784

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Study Location
Pfizer New Haven Clinical Research Unit
New Haven, Connecticut, 06511, United States
See other locations
Contact
1-800-254-6398
[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

1-800-254-6398

By email

Contact

[email protected]

Call Now

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

- Healthy female subjects of nonchildbearing potential and/or male subjects

- Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs).

- Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study

- Subjects who are willing and able to comply with all 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 hematological, renal, endocrine,
pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or
allergic disease


- Any condition possibly affecting the placement of an intravenous drug administration
line.


- A confirmed positive urine drug screen


- History of regular alcohol consumption exceeding 7 drinks/week for females or 14
drinks/week for males (1 drink = 5 ounces (150 mL) of wine or 12 ounces (360 mL) of
beer or 1.5 ounces (45 mL) of hard liquor) within 6 months of screening


- Use of tobacco- or nicotine-containing products in excess of the equivalent of 5
cigarettes per day or 2 chews of tobacco per day


- Treatment with an investigational drug within 30 days (or as determined by the local
requirement)


- Screening supine blood pressure >140 mm Hg (systolic) or <90 mm Hg (diastolic),
following at least 5 minutes of supine rest


- Screening supine 12-lead ECG demonstrating QTc >450 msec or a QRS interval >120 msec.


- Blood donation (excluding plasma donations) of approximately 1 pint (500 mL) or more
within 60 days prior to dosing.


- History of sensitivity to heparin or heparin-induced thrombocytopenia


- History of human immunodeficiency virus (HIV), hepatitis B or C; positive testing for
HIV, hepatitis B surface antigen (HepBsAg), hepatitis B core antibody (HepBcAb) or
hepatitis C antibody (HCVAb).


- Other acute or chronic medical or psychiatric condition including recent (within the
past year) or active suicidal ideation or behavior or laboratory abnormality that may
increase the risk associated with study participation or investigational product

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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

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[email protected]

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Advanced Information
Descriptive Information
Brief Title  ICMJE Safety and Tolerability of PF-06818883 in Healthy Subjects
Official Title  ICMJE A Phase 1, Randomized, Double-blind, Sponsor-open, Placebo-controlled, Single-ascending Dose Study To Evaluate The Safety, Tolerability And Pharmacokinetics Of Pf-06818883 Following Single Intravenous Administration In Healthy Subjects
Brief Summary Safety, Tolerability and Pharmacokinetics of PF-06818883
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Healthy
Intervention  ICMJE
  • Drug: Placebo
    Placebo
  • Drug: PF-06818883
    Treatment
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    IV placebo
    Intervention: Drug: Placebo
  • Experimental: PF-06818883
    Experimental drug
    Intervention: Drug: PF-06818883
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: July 31, 2017)		30
Original Estimated Enrollment  ICMJE
 (submitted: January 11, 2017)		96
Actual Study Completion Date  ICMJE June 13, 2017
Actual Primary Completion Date June 13, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy female subjects of nonchildbearing potential and/or male subjects
  • Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs).
  • Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study
  • Subjects who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures

Exclusion Criteria:

  • Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease
  • Any condition possibly affecting the placement of an intravenous drug administration line.
  • A confirmed positive urine drug screen
  • History of regular alcohol consumption exceeding 7 drinks/week for females or 14 drinks/week for males (1 drink = 5 ounces (150 mL) of wine or 12 ounces (360 mL) of beer or 1.5 ounces (45 mL) of hard liquor) within 6 months of screening
  • Use of tobacco- or nicotine-containing products in excess of the equivalent of 5 cigarettes per day or 2 chews of tobacco per day
  • Treatment with an investigational drug within 30 days (or as determined by the local requirement)
  • Screening supine blood pressure >140 mm Hg (systolic) or <90 mm Hg (diastolic), following at least 5 minutes of supine rest
  • Screening supine 12-lead ECG demonstrating QTc >450 msec or a QRS interval >120 msec.
  • Blood donation (excluding plasma donations) of approximately 1 pint (500 mL) or more within 60 days prior to dosing.
  • History of sensitivity to heparin or heparin-induced thrombocytopenia
  • History of human immunodeficiency virus (HIV), hepatitis B or C; positive testing for HIV, hepatitis B surface antigen (HepBsAg), hepatitis B core antibody (HepBcAb) or hepatitis C antibody (HCVAb).
  • Other acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation or investigational product
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 NCT03020784
Other Study ID Numbers  ICMJE C0601001
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date December 2017

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