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HealthyPhase 1NCT02609139

Study to Evaluate Pharmacokinetics of A Modified Release Formulation of PF-06650833 in Healthy Subjects

A Phase 1 study testing PF-06650833 in people with Healthy, run by Pfizer at 1 site in United States.

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

This is a Phase 1, open-label, single-dose, within-cohort randomized, 2-way crossover study to evaluate the PK of orally administered PF-06650833 modified release tablets under fasted and high fat meal fed conditions in healthy subjects. 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-06650833
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
18 participants
Where
1 siteUnited States
Study dates
Nov 2015to Feb 2016
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 female subjects of non childbearing potential and/or male subjects, between the ages of 18 and 55 years
  • BMI of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs).
  • Personally signed and dated Informed Consent
  • Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.

Who cannot join

  • Clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease
  • Any condition possibly affecting drug absorption
  • Positive urine drug screen.
  • Heavy smokers
  • History of regular heavy alcohol consumption within 6 months of Screening.
  • Treatment with an investigational drug within 30 days (or as determined by the local requirement) or 5 half lives
Show all 31Show fewer
  • Screening supine blood pressure <=100 mm Hg (systolic) or<=50 mm Hg (diastolic) or>=140 mm Hg (systolic) or >=90 mm Hg (diastolic), following at least 5 minutes of supine rest.
  • Screening pulse (HR) >100 bpm after at least 5 minutes of rest.
  • Single supine 12 lead ECG demonstrating QTc >450 msec or a QRS interval >120 msec at Screening.
  • Abnormal chest X ray
  • History of TB or active or latent or inadequately treated infection, positive Quantiferon TB test.
  • History of hepatitis or positive testing for human HIV,HepBsAg, HepBc Ab or HCVAb
  • Any medical history of disease [ie, Gilbert's disease] that has the potential to cause a rise in total bilirubin over the ULN
  • Clinical laboratory abnormalities including:
  • Creatine kinase >1.2 X ULN;
  • CK MB > ULN;
  • Serum myoglobin >1.2 X ULN;
  • Cardiac Troponin I (cTn I) > ULN of the laboratory reference range;
  • Serum aspartate transaminase (AST) or alanine transaminase (ALT) >=2 x ULN, total serum bilirubin >=1.5 mg/dL;
  • Subjects with benign ethnic neutropenia;
  • Hemoglobin <=14 gm/dl (males) and <=13 gm/dL (females).
  • Nursing female subjects; male subjects with partners currently pregnant; male subjects able to father children 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 28 days after the last dose of investigational product or longer based upon the compound's half life characteristics.
  • Use of prescription or nonprescription drugs and dietary supplements within 7 days or 5 half lives (whichever is longer) prior to the first dose of investigational product until discharge from the study at the end of Period 2.
  • Herbal supplements and hormone replacement therapy must be discontinued 28 days prior to the first dose of investigational product. Acetaminophen/paracetamol should not be used. As an exception, ibuprofen may be used at doses of 200 to 400 mg orally every 6 hours as needed for up to 3 of 7 consecutive days.
  • Blood donation (excluding plasma donations) of approximately 1 pint (500 mL) or more within 56 days prior to dosing.
  • History of sensitivity to heparin or heparin induced thrombocytopenia.
  • History of cancer (other than treated basal cell and squamous cell carcinoma of the skin) in the previous 5 years.
  • Previous exposure to PF 06650833.
  • Unwilling or unable to comply with the Lifestyle guidelines
  • Subjects who are investigational 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 directly involved in the conduct of the study.
  • Other severe acute or chronic medical or psychiatric condition or laboratory abnormality

Trial locations and contacts

1 site in 1 country.

United States1 site

  • New Haven Clinical Research Unit

    New Haven, Connecticut, 06511

Other trials in United States

About this study

Official title: A Phase 1, Open Label, Single-Dose, Within Cohort Randomized, 2-Way Crossover Study To Evaluate The Pharmacokinetics Of A Modified Release Formulation Of Pf-06650833 Under Fasting And Fed Conditions In Healthy Adult Subjects

This is a Phase 1, open-label, single-dose, within-cohort randomized, 2-way crossover study to evaluate the PK of orally administered PF-06650833 modified release tablets under fasted and high fat meal fed conditions in healthy subjects.

Read the detailed description

This is the third study of PF-06650833. The goals of the study are to assess the PK in healthy subjects of single doses of modified release (MR) tablets of PF-06650833 when orally administered under fasting and high fat meal fed conditions.

Conditions
Healthy
Being tested
PF-06650833

What participants receive

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

  • PF-06650833Drug

    Up to 400mg modified release tablets administered under fasted conditions

  • PF-06650833Drug

    100mg modified release tablet administered under fasted conditions

  • PF-06650833Drug

    20mg modified release tablet administered under fasted conditions

  • PF-06650833Drug

    Up to 400mg modified release tablets administered with high fat meal food intake

  • PF-06650833Drug

    100mg modified released tablet administered with high fat meal food intake

  • PF-06650833Drug

    20 mg modified release tablet administered with high fat meal food intake

Study groups in NCT02609139
Study groupRoleWhat they receive
<=400mg Modified Release Tablets, FastedExperimentalUp to 400 mg PF-06650833 modified release tablets administered under fasted conditions
Receives: Drug: PF-06650833
100mg Modified Release Tablets, FastedExperimental100 mg PF-06650833 modified release tablets administered under fasted conditions
Receives: Drug: PF-06650833
20mg Modified Release Tablets, FastedExperimental20 mg PF-06650833 modified release tablets administered under fasted conditions
Receives: Drug: PF-06650833
<= 400mg Modified Release Tablets, FedExperimentalUp to 400 mg PF-06650833 modified release tablets administered with high fat meal food intake
Receives: Drug: PF-06650833
100mg Modifed Release Tablets, FedExperimental100 mg PF-06650833 modified release tablets administered with high fat meal food intake
Receives: Drug: PF-06650833
20mg Modified Release Tablets, FedExperimental20 mg PF-06650833 modified release tablets administered with high fat meal food intake
Receives: Drug: PF-06650833

What is being measured

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

  1. Plasma pharmacokinetic parameters of PF-06650833

    Maximum plasma concentration (Cmax) of PF-06650833

    Measured: Baseline to up to Day 14 (0 to +1) postdose

  2. Plasma pharmacokinetic parameters of PF-06650833

    Area under the plasma concentration versus time curve from time zero to the time of the last quantifiable concentration (AUClast) of PF-06650833

    Measured: Baseline to up to Day 14 (0 to +1) postdose

  3. Plasma pharmacokinetic parameters of PF-06650833

    Area under the plasma concentration versus time curve from time zero extrapolated to infinite time (AUCinf) of PF-06650833 (if data permit)

    Measured: Baseline to up to Day 14 (0 to +1) postdose

  4. Plasma pharmacokinetic parameters of PF-06650833

    Dose-normalized maximum plasma Cmax (Cmax(dn)) of PF-06650833

    Measured: Baseline to up to Day 14 (0 to +1) postdose

  5. Plasma pharmacokinetic parameters of PF-06650833

    Dose-normalized area under the plasma concentration versus time curve from time zero to the time of the last quantitfiable concentration (AUClast(dn)) of PF-06650833

    Measured: Baseline to up to Day 14 (0 to +1) postdose

  6. Plasma pharmacokinetic parameters of PF-06650833 (if data permit)

    Dose-normalized area under the plasma concentration versus time curve from time zero extrapolated to infinite time (AUCinf(dn)) of PF-06650833 (if data permit)

    Measured: Baseline to up to Day 14 (0 to +1) postdose

Secondary outcomes (10)

  1. Plasma pharmacokinetic parameters of PF-06650833

    Time post dose associated with the maximum plasma concentration (Tmax) of PF-06650833

    Measured: Baseline to up to Day 14 (0 to +1) postdose

  2. Plasma pharmacokinetic parameters of PF-06650833

    Terminal half life of PF-06650833 (if data permit)

    Measured: Baseline to up to Day 14 (0 to +1) postdose

  3. Plasma pharmacokinetic parameters of PF-06650833

    Lag time of plasma concentration of PF-06650833 (if data permit)

    Measured: Baseline to up to Day 14 (0 to +1) postdose

  4. Plasma pharmacokinetic parameters of PF-06650833

    Absorption rate constant of PF-06650833 (Ka) (if data permit)

    Measured: Baseline to up to Day 14 (0 to +1) postdose

  5. Plasma pharmacokinetic parameters of PF-06650833

    Apparent Clearance (CL/F) of PF-06650833 (if data permit)

    Measured: Baseline to up to Day 14 (0 to +1) postdose

  6. Plasma pharmacokinetic parameters of PF-06650833

    Apparent Volume of Distribution (Vz/F) of PF-06650833 (if data permit)

    Measured: Baseline for up to Day 14 (0 to +1) postdose

  7. Treatment emergent adverse events and withdrawals

    Incidence and severity of treatment emergent adverse events and withdrawals due to treatment emergent adverse events

    Measured: Baseline to up to Day 14 (0 to +1) postdose

  8. Vital signs

    Changes from baseline in vital signs (blood pressure, pulse rate, and respiratory rate)

    Measured: Baseline to up to Day 14 (0 to +1) postdose

  9. Electrocardiogram parameters

    Changes from baseline in electrocardiogram parameters (standard 12-lead ECG)

    Measured: Baseline to up to Day 14 (0 to +1) postdose

  10. Clinical laboratory measurement

    Changes from baseline in clinical laboratory values

    Measured: Baseline to up to Day 14 (0 to +1) postdose

Timeline

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

  1. First posted20 Nov 2015 (estimated)
  2. Study startNov 2015
  3. Primary completionFeb 2016
  4. Study completionFeb 2016

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
18 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02609139
Sponsor's protocol ID
B7921004
Other IDs
IRAK4 MR PK Study
Status last verified
May 2016
First submitted
5 Nov 2015
Last updated
9 May 2016
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing PF-06650833 in people with Healthy, run by Pfizer at 1 site in United States.

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 4 inclusion and 31 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 9 May 2016. 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 United States. 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?

Plasma pharmacokinetic parameters of PF-06650833 (time frame: Baseline to up to Day 14 (0 to +1) postdose). The study lists 6 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 NCT02609139.

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 9 May 2016.

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