Clinical Trials/NCT04390776

NCT04390776

Completed

Phase 1

A PHASE 1, RANDOMIZED, OPEN-LABEL, CROSS-OVER, SINGLE-DOSE STUDY TO EVALUATE THE BIOEQUIVALENCE OF CANDIDATE CAPSULE FORMULATIONS OF PF-06651600 TO TABLETS AND ESTIMATE THE EFFECT OF HIGH-FAT MEAL ON BIOAVAILABILITY IN HEALTHY PARTICIPANTS

Pfizer2 sites in 1 country164 target enrollmentSeptember 28, 2020

ConditionsHealthy Participants

InterventionsPF-06651600

DrugsPF-06651600

Overview

Phase: Phase 1
Intervention: PF-06651600
Conditions: Healthy Participants
Sponsor: Pfizer
Enrollment: 164
Locations: 2
Primary Endpoint: Area under the plasma concentration-time profile from time zero extrapolated to infinite time (AUCinf)of PF-06651600
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The study will be conducted as a Phase 1, open-label, single-dose, randomized, 2- or 3 period, cross over design in a single cohort.

Registry

clinicaltrials.gov

Start Date

September 28, 2020

End Date

July 19, 2021

Last Updated

4 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Pfizer

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Male and female participants who are healthy as determined by medical evaluation including a detailed medical history, complete physical examination, which includes BP and pulse rate measurement, clinical laboratory tests, and cardiac evaluation (including ECG).
•BMI of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lb).

Exclusion Criteria

•Evidence or history of clinically significant hematological, renal, endocrine (including diabetes), pulmonary, gastrointestinal, cardiovascular (including hypertension and congestive heart failure), hepatic, psychiatric, neurological, dermatological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
•Any condition possibly affecting drug absorption (eg, gastrectomy, cholecystectomy).
•Known immunodeficiency disorder, including positive serology for human immunodeficiency virus (HIV) at screening, or a first degree relative with a hereditary immunodeficiency.
•Participants with any of the following acute or chronic infections or infection history:
•Any infection requiring treatment within 2 weeks prior to the dosing visit.
•Any infection requiring hospitalization or parenteral antimicrobial therapy within 60 days of the first dose of study intervention.
•Any infection judged to be an opportunistic infection or clinically significant by the investigator, within the past 6 months of the first dose of study intervention.
•Known active or history of recurrent bacterial, viral, fungal, mycobacterial or other infections.
•History of recurrent (more than one episode of) localized dermatomal herpes zoster, or history of disseminated (single episode) herpes simplex or disseminated herpes zoster.

Arms & Interventions

Treatment Sequence 2

PF-06651600 100 mg Capsules (fasted, Period 1), followed by Tablets (fasted, Period 2), and followed by Capsules (fed, Period 3).

Intervention: PF-06651600

Treatment Sequence 3

PF-06651600 100 mg Tablets (fasted, Period 1), followed by Capsules (fasted, Period 2).

Intervention: PF-06651600

Treatment Sequence 1

PF-06651600 100 mg Tablets (fasted, Period 1), followed by Capsules (fasted, Period 2), and followed by Capsules (fed, Period 3).

Intervention: PF-06651600

Treatment Sequence 4

PF-06651600 100 mg Capsules (fasted, Period 1), followed by Tablets (fasted, Period 2).

Intervention: PF-06651600

Outcomes

Primary Outcomes

Area under the plasma concentration-time profile from time zero extrapolated to infinite time (AUCinf)of PF-06651600

Time Frame: Day 1 pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 12, and 16 hrs, and Day 2, at 24 hours post-dose.

Maximum plasma PF-06651600 concentration (C max)

Time Frame: Day 1 pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 12, and 16 hrs, and Day 2, at 24 hours post-dose.

Secondary Outcomes

Single dose time to reach maximum observed plasma concentration (Tmax) of PF-06651600(Day 1 pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 12, and 16 hrs, and Day 2, at 24 hours post-dose.)
Single dose Area under the Curve from Time Zero to Last quantifiable concentration [AUC last) of PF-06651600(Day 1 pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 12, and 16 hrs, and Day 2, at 24 hours post-dose.)
Single dose plasma decay half-life (t 1/2) of PF-06651600(Day 1 pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 12, and 16 hrs, and Day 2, at 24 hours post-dose.)
Single dose Apparent Oral Clearance (CL/F) of PF-06651600(Day 1 pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 12, and 16 hrs, and Day 2, at 24 hours post-dose.)
Single dose Apparent Volume of Distribution (Vz/F) of PF-06651600(Day 1 pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 12, and 16 hrs, and Day 2, at 24 hours post-dose.)
Frequency of abnormal safety laboratory tests(Baseline up to day 9)
Frequency of Adverse Events(Baseline up to day 35)