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OpenTrials
Completed

NCT Number: NCT03871439

OPEN LABEL, 2-PERIOD STUDY, TO COMPARE BIO-AVAILABILITY OF 2 DIFFERENT FORMULATIONS OF PF-05221304 IN HEALTHY ADULTS

The purpose of this study is to characterize the plasma pharmacokinetics of two formulations of PF 05221304 in healthy adults.

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Key information

Conditions

Healthy

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer New Haven Clinical Research Unit

New Haven, Connecticut, 06511, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PF-05221304 Formulation A

Drug

50mg

PF-05221304 Formulation B

Drug

50mg

Primary outcomes

  1. Plasma PF-05221304 AUClast

    Time frame: Thirteen timepoints between 0-72 Hours

    Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)

  2. Plasma PF-05221304 Cmax

    Time frame: Thirteen timepoints between 0-72 Hours

    Maximum Observed Plasma Concentration (Cmax)

Secondary outcomes

  1. 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

  2. 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]).

  3. 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

  4. 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.

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Mar 12, 2019
Registry last updated
May 20, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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