Safety and Tolerability of PF-06818883 in Healthy Subjects
NCT03020784
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-254-6398
- 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
- 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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Descriptive Information | |||||
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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 |
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Study Arms ICMJE |
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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 | 30 | ||||
Original Estimated Enrollment ICMJE | 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:
Exclusion Criteria:
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Sex/Gender ICMJE |
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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 |
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IPD Sharing Statement ICMJE | Not Provided | ||||
Responsible Party | Pfizer | ||||
Study Sponsor ICMJE | Pfizer | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE |
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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 |