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HealthyPhase 1NCT03372044

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

A Phase 1 study testing PF-06865571 Immediate release suspension, PF-06865571 Slow release MR tablets and PF-06865571 Fast release MR tablets in people with Healthy, run by Pfizer at 1 site in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
PF-06865571 Immediate release suspension, PF-06865571 Slow release MR tablets and PF-06865571 Fast release MR tablets
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
1 siteBelgium
Study dates
19 Jan 2018to 4 Apr 2018
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

1 site in 1 country.

Belgium1 site

  • Pfizer Clinical Research Unit

    Brussels, B-1070

Other trials in Belgium

About this study

Official title: 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

Conditions
Healthy
Being tested
PF-06865571 Immediate release suspension, PF-06865571 Slow release MR tablets, PF-06865571 Fast release MR tablets, PF-06865571 Immediate release tablets
Keywords
Relative bioavailability, Modified release, Pharmacokinetics

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PF-06865571 Immediate release suspensionDrug

    Suspension

  • PF-06865571 Slow release MR tabletsDrug

    Modified release tablets

  • PF-06865571 Fast release MR tabletsDrug

    Modified release tablets

  • PF-06865571 Immediate release tabletsDrug

    Immediate release tablets

Study groups in NCT03372044
Study groupRoleWhat they receive
PF-06865571ExperimentalTreatment
Receives: 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

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 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)

    Measured: 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)

    Measured: 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).

    Measured: 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)

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

Secondary outcomes (4)

  1. Number of subjects with adverse events (AEs)

    Number of participants with reported adverse events

    Measured: 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

    Measured: 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

    Measured: 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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Dec 2017
  2. Study start19 Jan 2018
  3. Primary completion9 Mar 2018
  4. Study completion4 Apr 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03372044
Sponsor's protocol ID
C2541003
Other IDs
2017-003797-14, 2017
Status last verified
Apr 2018
First submitted
6 Dec 2017
Last updated
17 Apr 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
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

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing PF-06865571 Immediate release suspension, PF-06865571 Slow release MR tablets and PF-06865571 Fast release MR tablets in people with Healthy, run by Pfizer at 1 site in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03372044.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2018.

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