Bioavailability Study of PF-06651600 Formulations in Healthy Participants

A PHASE 1, RANDOMIZED, OPEN-LABEL, CROSS-OVER, SINGLE DOSE STUDY TO ESTIMATE THE RELATIVE BIOAVAILABILITY OF CANDIDATE CAPSULE FORMULATIONS OF PF-06651600 RELATIVE TO TABLETS IN HEALTHY PARTICIPANTS

The study will be conducted as a Phase 1, open-label, single dose, randomized, 4-period, cross over design in a single cohort of approximately 12 healthy male or female participants at a single center. Participants will be randomized into 1 of 4 sequences of treatment.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: PF-06651600

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Phase 1

Contacts and Locations

Study Locations

• Belgium
  • Be-bru
    • Brussels, Be-bru, Belgium, B-1070
      • Brussels Clinical Research Unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

INCLUSION CRITERIA:

• 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 12 lead ECG.
• Participants with body mass index (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, pulmonary, gastrointestinal, cardiovascular, 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.
• Infection with hepatitis B or hepatitis C viruses

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment Sequence 1; Participants will receive a single dose of each formulation of PF-06651600 in each period as follows: Period 1 (Treatment A); Period 2 (Treatment B); Period 3 (Treatment C); Period 4 (Treatment D).	Drug: PF-06651600; PF-06651600 100 milligrams (mg) will be provided in 4 different oral formulations (Treatment A,B,C,D). Participants will receive each formulation in one of 4 periods
Experimental: Treatment Sequence 2; Participants will receive a single dose of each formulation of PF-06651600 in each period as follows: Period 1 (Treatment B); Period 2 (Treatment D); Period 3 (Treatment A); Period 4 (Treatment C).	Drug: PF-06651600; PF-06651600 100 milligrams (mg) will be provided in 4 different oral formulations (Treatment A,B,C,D). Participants will receive each formulation in one of 4 periods
Experimental: Treatment Sequence 3; Participants will receive a single dose of each formulation of PF-06651600 in each period as follows: Period 1 (Treatment C); Period 2 (Treatment A); Period 3 (Treatment D); Period 4 (Treatment B).	Drug: PF-06651600; PF-06651600 100 milligrams (mg) will be provided in 4 different oral formulations (Treatment A,B,C,D). Participants will receive each formulation in one of 4 periods
Experimental: Treatment Sequence 4; Participants will receive a single dose of each formulation of PF-06651600 in each period as follows: Period 1 (Treatment D); Period 2 (Treatment C); Period 3 (Treatment B); Period 4 (Treatment A).	Drug: PF-06651600; PF-06651600 100 milligrams (mg) will be provided in 4 different oral formulations (Treatment A,B,C,D). Participants will receive each formulation in one of 4 periods

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Area under the plasma concentration-time profile from time zero extrapolated to infinite time (AUCinf)of PF-06651600	Day 1 pre-dose and at 0.25, 0.5, 1, 2, 3, 4, 6, 12, and 16 hrs, and Day 2, at 24 hours post-dose in Periods 1-4.
Maximum plasma PF-06651600 concentration (C max)	Day 1 pre-dose and at 0.25, 0.5, 1, 2, 3, 4, 6, 12, and 16 hrs, and Day 2, at 24 hours post-dose in Periods 1-4.

Secondary Outcome Measures

Outcome Measure	Time Frame
Single dose time to reach maximum observed plasma concentration (Tmax) of PF-06651600	Day 1 pre-dose and at 0.25, 0.5, 1, 2, 3, 4, 6, 12, and 16 hrs, and Day 2, at 24 hours post-dose in Periods 1-4.
Single dose Area under the Curve from Time Zero to Last quantifiable concentration [AUC last) of PF-06651600	Day 1 pre-dose and at 0.25, 0.5, 1, 2, 3, 4, 6, 12, and 16 hrs, and Day 2, at 24 hours post-dose in Periods 1-4.
Single dose plasma decay half-life (t 1/2) of PF-06651600	Day 1 pre-dose and at 0.25, 0.5, 1, 2, 3, 4, 6, 12, and 16 hrs, and Day 2, at 24 hours post-dose in Periods 1-4.
Single dose Apparent Oral Clearance (CL/F) of PF-06651600	Day 1 pre-dose and at 0.25, 0.5, 1, 2, 3, 4, 6, 12, and 16 hrs, and Day 2, at 24 hours post-dose in Periods 1-4.
Single dose Apparent Volume of Distribution (Vz/F) of PF-06651600	Day 1 pre-dose and at 0.25, 0.5, 1, 2, 3, 4, 6, 12, and 16 hrs, and Day 2, at 24 hours post-dose in Periods 1-4.
Frequency of abnormal safety laboratory tests	Baseline up to day 9
Frequency of Adverse Events	Baseline up to Day 35

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start (Actual): July 15, 2019
• Primary Completion (Actual): October 11, 2019
• Study Completion (Actual): October 11, 2019

Study Registration Dates

• First Submitted: June 28, 2019
• First Submitted That Met QC Criteria: June 28, 2019
• First Posted (Actual): July 2, 2019

Study Record Updates

• Last Update Posted (Actual): November 1, 2019
• Last Update Submitted That Met QC Criteria: October 30, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: pharmacokinetics; JAK inhibitor; PF-06651600
• Other Study ID Numbers: B7981022; 2019-001452-19 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No