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

Sponsor
Pfizer (Industry)
Overall Status
Completed
CT.gov ID
NCT03871439
Collaborator
(none)
10
Enrollment
1
Location
2
Arms
1.8
Actual Duration (Months)
5.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Drug: PF-05221304 Formulation A
  • Drug: PF-05221304 Formulation B
 Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
10 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official 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
Actual Study Start Date :
Mar 13, 2019
Actual Primary Completion Date :
May 8, 2019
Actual Study Completion Date :
May 8, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: PF-05221304 Formulation A

Drug: PF-05221304 Formulation A
50mg
Experimental: PF-05221304 Formulation B

Drug: PF-05221304 Formulation B
50mg

Outcome Measures

Primary Outcome Measures

  1. Plasma PF-05221304 AUClast [Thirteen timepoints between 0-72 Hours]

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

  2. Plasma PF-05221304 Cmax [Thirteen timepoints between 0-72 Hours]

    Maximum Observed Plasma Concentration (Cmax)

Secondary Outcome Measures

  1. Number of Subjects Experiencing an Adverse Event [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 [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 [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) [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 55 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Pfizer New Haven Clinical Research Unit New Haven Connecticut United States 06511

Sponsors and Collaborators

  • Pfizer

Investigators

  • Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Pfizer
ClinicalTrials.gov Identifier:
NCT03871439
Other Study ID Numbers:
  • C1171007
First Posted:
Mar 12, 2019
Last Update Posted:
May 20, 2020
Last Verified:
May 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of May 20, 2020