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Trial record 1 of 1 for:    NCT03871439
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OPEN LABEL, 2-PERIOD STUDY, TO COMPARE BIO-AVAILABILITY OF 2 DIFFERENT FORMULATIONS OF PF-05221304 IN HEALTHY ADULTS

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ClinicalTrials.gov Identifier: NCT03871439
Recruitment Status : Completed
First Posted : March 12, 2019
Last Update Posted : May 20, 2020
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE February 25, 2019
First Posted Date  ICMJE March 12, 2019
Last Update Posted Date May 20, 2020
Actual Study Start Date  ICMJE March 13, 2019
Actual Primary Completion Date May 8, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 11, 2019)
  • Plasma PF-05221304 AUClast [ Time Frame: Thirteen timepoints between 0-72 Hours ]
    Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
  • Plasma PF-05221304 Cmax [ Time Frame: Thirteen timepoints between 0-72 Hours ]
    Maximum Observed Plasma Concentration (Cmax)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 11, 2019)
  • Number of Subjects Experiencing an Adverse Event [ Time Frame: Up to 10 weeks from screening ]
    Number of Participants With Adverse Events (AEs) by Seriousness and Relationship to Treatment
  • Number of Participants With Clinical Laboratory Abnormalities [ Time Frame: Up to 10 weeks from screening ]
    Following parameters were analyzed for laboratory examination: hematology (hemoglobin, hematocrit, red blood cell count, platelet count, white blood cell count, total neutrophils, eosinophils, monocytes, basophils, lymphocytes); liver function (aspartate aminotransferase, alanine aminotransferase, total bilirubin, lactate dehydrogenase, alkaline phosphatase, albumin, total protein); renal function (blood urea nitrogen, creatinine, uric acid); electrolytes (sodium, potassium, chloride, calcium, phosphate, bicarbonate); clinical chemistry (glucose, creatine kinase); immunology (CRP); urinalysis (dipstick [urine specific gravity, decimal logarithm of reciprocal of hydrogen ion activity {pH} of urine, glucose, protein, blood, ketones, bilirubin], microscopy [urine RBC, WBC, urate crystals, calcium, oxalate, miscellaneous [urine mucus and leucocytes]).
  • Number of Participants With Categorical Vital Signs Data [ Time Frame: Up to 10 weeks from screening ]
    Number of participants with maximum increase from Baseline in sitting Systolic Blood Pressure and Diastolic Blood Pressure of greater than or equal to 30 mmHg
  • Number of Participants With Abnormal Electrocardiogram (ECG) [ Time Frame: Up to 10 weeks from screening ]
    Criteria for potential clinical concern in ECG parameters: Maximum corrected QT interval (QTc) in range of 450 to less than 480 millisecond (msec), Maximum QTcB interval (Bazett's Correction) (msec) in range of 450 to less than 480 msec, Maximum QTcF interval (Fridericia's Correction) in range of 450 to less than 480 msec, maximum QTc interval increase from baseline in range of 30 to less than 60 msec and >=60 msec.
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 OPEN LABEL, 2-PERIOD STUDY, TO COMPARE BIO-AVAILABILITY OF 2 DIFFERENT FORMULATIONS OF PF-05221304 IN HEALTHY ADULTS
Official Title  ICMJE A PHASE 1, OPEN LABEL, TWO-PERIOD, RANDOMIZED CROSSOVER STUDY TO COMPARE THE PHARMACOKINETICS OF TWO DIFFERENT FORMULATIONS OF PF-05221304 ADMINISTERED ORALLY TO HEALTHY ADULT SUBJECTS
Brief Summary The purpose of this study is to characterize the plasma pharmacokinetics of two formulations of PF 05221304 in healthy adults.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Healthy
Intervention  ICMJE
  • Drug: PF-05221304 Formulation A
    50mg
  • Drug: PF-05221304 Formulation B
    50mg
Study Arms  ICMJE
  • Experimental: PF-05221304 Formulation A
    Intervention: Drug: PF-05221304 Formulation A
  • Experimental: PF-05221304 Formulation B
    Intervention: Drug: PF-05221304 Formulation B
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: March 11, 2019)
10
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 8, 2019
Actual Primary Completion Date May 8, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Ages of 18 and 55 years old inclusive
  • Body Mass Index (BMI) of >= 17.5 and <= 30.4 kg/m2
  • Total body weight > 50 kg (110lb)

Exclusion Criteria:

  • Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, allergic disease or clinical findings
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 NCT03871439
Other Study ID Numbers  ICMJE C1171007
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 May 2020

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