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CompletedNCT03372044Updated Apr 17, 2018

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

A Phase 1 interventional study of PF-06865571 Immediate release suspension and PF-06865571 Slow release MR tablets in Healthy, sponsored by Pfizer. Completed at 1 site in Belgium. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-04-17.

Sponsored by Pfizer · Phase 1, Interventional, and Basic science

Phase
Phase 1
Study type
Interventional
Enrollment
12
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Healthy

Keywords

  • Relative bioavailability
  • Modified release
  • Pharmacokinetics
03

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
04

Study design

Phase
Phase 1
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
12 participants (actual)

Study arms

  • Experimental
    PF-06865571

    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

Interventions

  • DrugPF-06865571 Immediate release suspension

    Suspension

  • DrugPF-06865571 Slow release MR tablets

    Modified release tablets

  • DrugPF-06865571 Fast release MR tablets

    Modified release tablets

  • DrugPF-06865571 Immediate release tablets

    Immediate release tablets

05

What researchers measure

Primary outcomes

  1. Maximum Observed Plasma Concentration (Cmax) for PF-06865571

    Time frame: 0,0.5,1,2,3,4,6,8,12,24,36,48 hours post dose in each period

  2. Time to Reach Maximum Observed Concentration for PF-06865571

    Time to Reach Maximum Observed Plasma Concentration (Tmax)

    Time frame: 0,0.5,1,2,3,4,6,8,12,24,36,48 hours post dose in each period

  3. 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)

    Time frame: 0,0.5,1,2,3,4,6,8,12,24,36,48 hours post dose in each period

  4. 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).

    Time frame: 0,0.5,1,2,3,4,6,8,12,24,36,48 hours post dose in each period

  5. Plasma Decay Half-Life (t1/2) for PF-06865571

    Plasma Decay Half-Life (t1/2)

    Time frame: 0,0.5,1,2,3,4,6,8,12,24,36,48 hours post dose in each period

Secondary outcomes

  1. Number of subjects with adverse events (AEs)

    Number of participants with reported adverse events

    Time frame: Baseline up to 35 days after last dose

  2. Number of subjects with laboratory tests findings of potential clinical importance

    Number of participants with potentially clinically important laboratory test findings

    Time frame: Baseline (Day 0) up to 48 hours after last dose of study medication

  3. Number of subjects with electrocardiogram (ECG) findings of potential clinical importance

    Number of participants with potentially clinically important ECG findings

    Time frame: Baseline (Day 0) up to 48 hours after last dose of study medication

  4. Number of subjects with vital signs findings of potential clinical importance

    Number of participants with potentially clinically important vital sign measurements

    Time frame: Baseline (Day 0) up to 48 hours after last dose of study medication

06

Study locations

1 site
  • Pfizer Clinical Research Unit
    Brussels, B-1070, Belgium
07

References and documents

Individual participant data

Plan to share: No — 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

08

Registry details

Key details

Study ID
NCT03372044
Lead sponsor
Pfizer
Responsible party
Sponsor
First posted
Dec 13, 2017
Start date
Jan 19, 2018
Primary completion
Mar 9, 2018
Completion
Apr 4, 2018
Last update
Apr 17, 2018

Study contacts

Pfizer CT.gov Call Center
study director · Pfizer

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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