AStudy to Evaluate the Bioavailability of PF 04965842 in Healthy Subjects
A Phase 1, Open Label, Single Dose 3 Way Crossover Study to Evaluate the Bioavailability of a Solid Dose Formulation of PF 04965842 Relative to a Suspension Formulation Under Fasting Conditions and the Effect of Food on the Bioavailability of the Solid Dosage Formulation of Pf 04965842 in Healthy Subjects
1 other identifier
interventional
12
1 country
1
Brief Summary
Phase 1, open label, single dose, 3 way crossover study to evaluate the bioavailability of a solid dose formulation of PF 04965842 relative to a suspension formulation under fasting conditions and the effect of food on the bioavailability of the solid dosage formulation of PF 04965842 in healthy subjects.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1 healthy
Started Jun 2014
Shorter than P25 for phase_1 healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2014
CompletedFirst Submitted
Initial submission to the registry
June 11, 2014
CompletedFirst Posted
Study publicly available on registry
June 13, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2014
CompletedAugust 18, 2014
August 1, 2014
2 months
June 11, 2014
August 15, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Area Under the Curve from Time Zero to infinity (AUC inf)
15 days
Maximum Observed Plasma Concentration (Cmax)
15 days
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)
15 days
Secondary Outcomes (2)
Time to Reach Maximum Observed Plasma Concentration (Tmax)
15 days
Plasma Decay Half-Life (t1/2)
15 days
Study Arms (3)
Treatment A
EXPERIMENTALTreatment B
EXPERIMENTALTreatment C
EXPERIMENTALInterventions
Subjects will receive 4 x 100 mg PF 04965842 tablet under fasted conditions
Eligibility Criteria
You may qualify if:
- Healthy male subjects and female subjects of non childbearing potential between the ages of 18 and 55 years, inclusive.
- Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lbs).
You may not qualify if:
- Subjects who received within 7 days prior to the first dose of study medication or are likely to receive during the study any moderate strong inhibitors of CYP3A4, eg, itraconazole, erythromycin, ketoconazole, protease inhibitors, verapamil, or diltiazem.
- Subjects who received within 28 days or are likely to receive during the study inducers of CYP3A4, eg rifampin.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (1)
Pfizer Investigational Site
Brussels, B-1070, Belgium
Related Publications (1)
Wojciechowski J, Malhotra BK, Wang X, Fostvedt L, Valdez H, Nicholas T. Population Pharmacokinetics of Abrocitinib in Healthy Individuals and Patients with Psoriasis or Atopic Dermatitis. Clin Pharmacokinet. 2022 May;61(5):709-723. doi: 10.1007/s40262-021-01104-z. Epub 2022 Jan 21.
PMID: 35061234DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 11, 2014
First Posted
June 13, 2014
Study Start
June 1, 2014
Primary Completion
August 1, 2014
Study Completion
August 1, 2014
Last Updated
August 18, 2014
Record last verified: 2014-08