A Study To Evaluate Different Formulations Of PF-06865571 In Healthy Subjects

A Phase 1, Open Label Study In Healthy Subjects To Investigate The Pharmacokinetics Of Pf 06865571 Following Single Oral Administration Of Immediate And Modified Release Tablets Compared To Immediate Release Oral Suspension Under Fed Conditions

An open-label study to understand the effect of different modified release and immediate release formulations on plasma PF-06865571 concentrations after single oral administration under fed conditions

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: PF-06865571 Immediate release suspension; Drug: PF-06865571 Slow release MR tablets; Drug: PF-06865571 Fast release MR tablets; Drug: PF-06865571 Immediate release tablets

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

Contacts and Locations

Study Locations

• Belgium
  • Brussels, Belgium, B-1070
    • Pfizer Clinical Research Unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Healthy males and female of non-childbearing potential
• Age of 18-55, inclusive
• Body Mass Index 17.5 to 30.5 kg/m2, inclusive
• Body weight >50 kg
• Not on any prescription or non-prescription drugs within 7 days or 5 half-lives prior to first dose.

Exclusion Criteria:

• Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, 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).
• A positive urine drug test.
• History of regular alcohol consumption exceeding 14 drinks/week for female subjects or 21 drinks/week for male subjects (1 drink = 5 ounces [150 mL] of wine or 12 ounces [360 mL] of beer or 1.5 ounces [45 mL] of hard liquor) within 6 months before screening.
• Treatment with an investigational drug within 30 days (or as determined by the local requirement) or 5 half lives preceding the first dose of investigational product (whichever is longer).
• Screening supine BP >=140 mm Hg (systolic) or >= 90 mm Hg (diastolic), following at least 5 minutes of supine rest.
• Screening supine 12 lead ECG demonstrating a corrected QT (QTc) interval >450 msec or a QRS interval >120 msec.

• Subjects with ANY of the following abnormalities in clinical laboratory tests at screening, as assessed by the study specific laboratory and confirmed by a single repeat test, if deemed necessary:

  • Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) level >=1.25 × upper limit of normal (ULN);
  • Total bilirubin level >=1.5 × ULN; subjects with a history of Gilbert's syndrome may have direct bilirubin measured and would be eligible for this study provided the direct bilirubin level is =<ULN.
• Fertile male subjects who are unwilling or unable to use a highly effective method of contraception as outlined in this protocol for the duration of the study and for at least 28 days after the last dose of investigational product.
• Blood donation (excluding plasma donations) of approximately 1 pint (500 mL) or more within 60 days prior to dosing.
• History of sensitivity to heparin or heparin induced thrombocytopenia only if heparin is used to flush any intravenous catheters in the study.
• History of human immunodeficiency virus (HIV), hepatitis B, or hepatitis C; positive testing for HIV, hepatitis B surface antigen (HepBsAg), hepatitis B core antibody (HepBcAb), or hepatitis C antibody (HCVAb).
• Unwilling or unable to comply with Lifestyle Requirements in the protocol
• Subjects who are investigator site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or subjects who are Pfizer employees, including their family members, directly involved in the conduct of the study.
• Other acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
• Subjects who have previously participated in prior studies with PF 06865571 as the investigational product.

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

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PF-06865571; Treatment	Drug: PF-06865571 Immediate release suspension; Suspension; Drug: PF-06865571 Slow release MR tablets; Modified release tablets; Drug: PF-06865571 Fast release MR tablets; Modified release tablets; Drug: PF-06865571 Immediate release tablets; Immediate release tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum Observed Plasma Concentration (Cmax) for PF-06865571		0,0.5,1,2,3,4,6,8,12,24,36,48 hours post dose in each period
Time to Reach Maximum Observed Concentration for PF-06865571	Time to Reach Maximum Observed Plasma Concentration (Tmax)	0,0.5,1,2,3,4,6,8,12,24,36,48 hours post dose in each period
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for PF-06865571	Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)	0,0.5,1,2,3,4,6,8,12,24,36,48 hours post dose in each period
Area Under the Curve From Time Zero to Extrapolated Infinite Time for PF-06865571	AUC (0-infinity)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-infinity). It is obtained from AUC (0-t) plus AUC (t-infinity).	0,0.5,1,2,3,4,6,8,12,24,36,48 hours post dose in each period
Plasma Decay Half-Life (t1/2) for PF-06865571	Plasma Decay Half-Life (t1/2)	0,0.5,1,2,3,4,6,8,12,24,36,48 hours post dose in each period

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of subjects with adverse events (AEs)	Number of participants with reported adverse events	Baseline up to 35 days after last dose
Number of subjects with laboratory tests findings of potential clinical importance	Number of participants with potentially clinically important laboratory test findings	Baseline (Day 0) up to 48 hours after last dose of study medication
Number of subjects with electrocardiogram (ECG) findings of potential clinical importance	Number of participants with potentially clinically important ECG findings	Baseline (Day 0) up to 48 hours after last dose of study medication
Number of subjects with vital signs findings of potential clinical importance	Number of participants with potentially clinically important vital sign measurements	Baseline (Day 0) up to 48 hours after last dose of study medication

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): January 19, 2018
• Primary Completion (Actual): March 9, 2018
• Study Completion (Actual): April 4, 2018

Study Registration Dates

• First Submitted: December 6, 2017
• First Submitted That Met QC Criteria: December 12, 2017
• First Posted (Actual): December 13, 2017

Study Record Updates

• Last Update Posted (Actual): April 17, 2018
• Last Update Submitted That Met QC Criteria: April 13, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: Pharmacokinetics; Relative bioavailability; Modified release
• Other Study ID Numbers: C2541003; 2017-003797-14 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Information relating to our policy on data sharing and the process for requesting data can be found at the following link: http://www.pfizer.com/research/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.: Yes