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Trial record 1 of 1 for:    NCT03656952
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A Study to Evaluate the PF-06700841 Effect on QTc Interval in Healthy Volunteers

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ClinicalTrials.gov Identifier: NCT03656952
Recruitment Status : Completed
First Posted : September 3, 2018
Last Update Posted : February 27, 2019
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE August 30, 2018
First Posted Date  ICMJE September 3, 2018
Last Update Posted Date February 27, 2019
Actual Study Start Date  ICMJE September 5, 2018
Actual Primary Completion Date February 6, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 30, 2018)
QTc change from baseline following PF-06700841 treatment [ Time Frame: 0 to 48 hours post-dose ]
QTc change from baseline at geometric mean of maximum concentrations observed after single doses of 200 mg PF-06700841 and maximum concentrations expected at lower doses of 30 and 60 mg.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03656952 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 30, 2018)
QTc change from baseline following moxifloxacin treatment [ Time Frame: 0-48 hours post-dose ]
QTc change from baseline at 3 hours (Tmax) after a single dose of 400 mg moxifloxacin administration
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
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
  • Drug: PF-06700841
    a single oral dose of 200 mg PF-06700841
  • Drug: Placebo
    Placebo matching PF-06700841
  • Drug: moxifloxacin
    a single oral dose of 400 mg moxifloxacin
Study Arms  ICMJE
  • Experimental: Seq 1
    PF-06700841-> placebo-> moxifloxacin
    Interventions:
    • Drug: PF-06700841
    • Drug: Placebo
    • Drug: moxifloxacin
  • Experimental: Seq 2
    PF-06700841->moxifloxacin->placebo
    Interventions:
    • Drug: PF-06700841
    • Drug: Placebo
    • Drug: moxifloxacin
  • Experimental: Seq 3
    Placebo->PF-06700841->moxifloxacin
    Interventions:
    • Drug: PF-06700841
    • Drug: Placebo
    • Drug: moxifloxacin
  • Experimental: Seq 4
    Placebo->moxifloxacin->PF-06700841
    Interventions:
    • Drug: PF-06700841
    • Drug: Placebo
    • Drug: moxifloxacin
  • Experimental: Seq 5
    Moxifloxacin->PF-06700841->placebo
    Interventions:
    • Drug: PF-06700841
    • Drug: Placebo
    • Drug: moxifloxacin
  • Experimental: Seq 6
    Moxifloxacin->placebo->PF-06700841
    Interventions:
    • Drug: PF-06700841
    • Drug: Placebo
    • Drug: moxifloxacin
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: February 25, 2019)
33
Original Estimated Enrollment  ICMJE
 (submitted: August 30, 2018)
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:

  • 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.

Exclusion Criteria:

  • 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.
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 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
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
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