A Study to Evaluate the PF-06700841 Effect on QTc Interval in Healthy Volunteers
NCT03656952
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
1-800-718-1021
- Healthy female subjects of non-childbearing potential and/or male subjects. Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including BP and pulse rate measurement, 12-lead ECG, or clinical laboratory tests.
- Body mass index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lb) at screening.
- 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 (including alcoholic liver
disease, nonalcoholic steatohepatitis (NASH), autoimmune hepatitis, and hereditary
liver diseases), psychiatric, neurological, or allergic disease (including drug
allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of
dosing)
- Self-reported history or risk factors for QT prolongation or torsades de pointes (eg,
organic heart disease, congestive heart failure, hypokalemia, hypomagnesaemia,
congenital long QT syndrome, myocardial ischemia or infarction), congenital deafness,
family history of sudden death, and family history of long QT syndrome.
- Treatment with an investigational drug within 30 days (or as determined by the local
requirement) or 5 half-lives preceding the first dose of investigational product
(whichever is longer)
- Subjects with known prior participation (ie, randomized and received at least 1 dose
of investigational product) in a trial involving PF-06700841
- History of tuberculosis or active or latent or inadequately treated infection,
positive QuantiFERON- tuberculosis (TB) Gold test
- History of human immunodeficiency virus (HIV), hepatitis B, or hepatitis C; positive
testing for HIV, hepatitis B surface antigen (HepBsAg), hepatitis B core antibody
(HepBcAb), or hepatitis C antibody (HCVAb)
- Blood donation (excluding plasma donations) of approximately 1 pint (500 mL) or more
within 60 days prior to dosing
- 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
administration or may interfere with the interpretation of study results and, in the
judgment of the investigator, would make the subject inappropriate for entry into this
study.
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Descriptive Information | |||||
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Brief Title ICMJE | A Study to Evaluate the PF-06700841 Effect on QTc Interval in Healthy Volunteers | ||||
Official Title ICMJE | A PHASE 1, RANDOMIZED, PLACEBO-AND POSITIVE-CONTROLLED CROSSOVER STUDY TO DETERMINE THE EFFECT OF SINGLE-DOSE PF-06700841 ON QTC INTERVAL IN HEALTHY VOLUNTEERS | ||||
Brief Summary | A phase 1, 6-sequence, 3-period, subject- and investigator blinded and sponsor-open, crossover study in healthy volunteers to evaluate the PF-06700841 effect on QTc interval. Each subject randomized will receive placebo, PF-06700841 200 mg and moxifloxacin (open label) in one of the 6 sequences. Moxifloxacin is positive control to demonstrate the study sensitivity and PF-06700841 effect on QTc will be assessed by concentration-QT analysis | ||||
Detailed Description | Not Provided | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 1 | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Double (Participant, Investigator) Primary Purpose: Basic Science | ||||
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 | Completed | ||||
Actual Enrollment ICMJE | 33 | ||||
Original Estimated Enrollment ICMJE | 36 | ||||
Actual Study Completion Date ICMJE | February 6, 2019 | ||||
Actual Primary Completion Date | February 6, 2019 (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 | Belgium | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT03656952 | ||||
Other Study ID Numbers ICMJE | B7931019 2018-001932-23 ( EudraCT Number ) | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Pfizer | ||||
Study Sponsor ICMJE | Pfizer | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE |
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PRS Account | Pfizer | ||||
Verification Date | February 2019 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |