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HealthyPhase 1NCT03250039

Absorption, Metabolism, Excretion and Absolute Bioavailability

A Phase 1 study testing PF-04965842 and Absolute Bioavailability in people with Healthy, run by Pfizer at 2 sites in Netherlands.

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 study will investigate the absorption, metabolism and excretion of 14C-PF 04965842 and characterize plasma, fecal and urinary radioactivity and identify any metabolites, if possible, of 14C PF-04965842 in humans. Read more about this study

Who is it for?
Ages 18 to 55 years, men onlyHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
PF-04965842 and Absolute Bioavailability
Could I receive a placebo?
No, everyone receives an active treatment
How many people
6 participants
Where
2 sitesNetherlands
Study dates
10 Jul 2017to 15 Sep 2017
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
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Healthy male subjects who, at the time of screening, are between the ages of 18 and 55 years, inclusive. Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12 lead electrocardiogram (ECG), or clinical laboratory tests.
  • Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs).
  • Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study.
  • Subjects who are willing and able to comply with study confinement period, scheduled visits, treatment plan, laboratory tests, contraceptive requirements and other study procedures.

Who cannot join

  • Subjects with any of the following characteristics/conditions will not be included in the study:
  • Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies).
  • Any clinically significant malabsorption condition (eg, gastrectomy, bowel resection).
  • A positive urine drug screen for drugs of abuse or recreational drugs.
  • 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).
  • History of abuse of alcohol or binge drinking and/or any other illicit drug use or dependence within 6 months of Screening. Binge drinking is defined as a pattern of 5 or more alcoholic drinks (male) in about 2 hours. As a general rule, alcohol intake should not exceed 21 units per week (1 unit = ½ pint beer, 25 mL of 40% spirit or a 125 mL glass of wine).
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  • Use of tobacco/nicotine containing products in excess of 5 cigarettes/day.
  • Treatment with an investigational drug within 60 days.
  • Total 14C radioactivity measured in plasma exceeding 11 mBq/mL.
  • Screening supine blood pressure >=140 mm Hg (systolic) or >=90 mm Hg (diastolic), following at least 5 minutes of supine rest. If blood pressure is >=140 mm Hg (systolic) or >=90 mm Hg (diastolic), the blood pressure measurement should be repeated two more times and the average of the three measurements should be used to assess the subject's eligibility.
  • Supine 12 lead ECG demonstrating QTcF >450 msec or a QRS interval >120 msec at screening. If QTcF exceeds 450 msec, or QRS exceeds 120 msec, the ECG should be repeated two more times and the average of the three QTcF or QRS values should be used to determine the subject's eligibility.
  • Use of prescription or nonprescription drugs (including vitamins and dietary supplements) within 7 days or 5 half lives (whichever is longer) prior to the first dose of study medication. As an exception, acetaminophen may be used at doses of =<1 g/day. Limited use of non prescription medications that are not believed to affect subject safety or the overall results of the study may be permitted on a case by case basis following approval by Pfizer.
  • Use of herbal supplements within 28 days prior to the first dose of study medication.
  • Blood donation (excluding plasma donations) of no more than 100 mL or more within 56 days prior to dosing.
  • An estimated glomerular filtration rate of <90 mL/min/1.73 m2 based on the four variable Modification of Diet in Renal Disease (MDRD) equation.
  • History of tuberculosis or active or latent or inadequately treated infection, positive QuantiFERON TB Gold test.
  • Any medical history of disease (ie, Gilbert's disease) that has the potential to cause a rise in total bilirubin over the upper limit of normal (ULN).
  • 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, if deemed necessary:
  • Serum aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >=1.5 × ULN, total serum bilirubin >= 25.6 micromol/L;
  • Hemoglobin =<2.17 mmol/L (males).
  • Known participation in a clinical trial for PF 04965842 within 60 days prior to the first dose of study medication.
  • Serious adverse reaction or serious hypersensitivity to any drug or the formulation excipients.
  • Unwilling or unable to comply with the Lifestyle Requirements described in this protocol.
  • 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, including their family members, directly involved in the conduct of the study.
  • Systemic therapy with any of the following medications that are CYP3A4 inhibitors within 7 days or 5 half lives (whichever is longer) or CYP3A inducers within 28 days prior to the first dose of the trial medication, or during the trial (Section 5.7).
  • History of sensitivity to heparin or heparin induced thrombocytopenia.
  • 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 with conditions that affect their ability to taste ie, dysgeusia, respiratory infection, cold, etc.
  • 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 90 days after the last dose of investigational product.

Trial locations and contacts

2 sites in 1 country.

Netherlands2 sites

  • PRA Health Sciences

    Groningen, 9713 GZ

  • PRA Health Sciences

    Groningen, 9728 NZ

Other trials in Netherlands

About this study

Official title: A Phase 1, Open-label, Non-randomized, 2-period, Fixed Sequence Study To Investigate The Absorption, Metabolism And Excretion Of [14c-pf-04965842] And To Assess The Absolute Bioavailability And Fraction Absorbed Of Pf-04965842 In Healthy Male Subjects Using A 14c-microtracer Approach

This study will investigate the absorption, metabolism and excretion of 14C-PF 04965842 and characterize plasma, fecal and urinary radioactivity and identify any metabolites, if possible, of 14C PF-04965842 in humans. In addition, this study will provide a better understanding of the pharmacokinetic disposition of PF-04965842 by obtaining intravenous (IV) clearance and delineating the extent of oral absorption (absolute bioavailability (F) and fraction absorbed (Fa)).

Conditions
Healthy
Being tested
PF-04965842, Absolute Bioavailability
Keywords
Absorption, Metabolism, Excretion, Absolute Bioavailability

What participants receive

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

  • PF-04965842Drug

    14C labeled PF-04965842

  • Absolute BioavailabilityDrug

    Oral dose of unlabeled PF-04965842 and an IV dose of 14C labeled PF- 04965842

Study groups in NCT03250039
Study groupRoleWhat they receive
Mass BalanceExperimentalCumulative recovery of radioactivity in urine and feces
Receives: Drug: PF-04965842
Absolute BioavailabilityExperimentalOral absolute bioavailability
Receives: Drug: Absolute Bioavailability

What is being measured

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

  1. Cumulative recovery of radioactivity

    Total radioactivity in urine and feces based on total administered dose.

    Measured: From predose to Day 14 day

Secondary outcomes (11)

  1. Cmax

    Maximum plasma concentration

    Measured: From predose to Day 5

  2. Tmax

    Time to maximum concentration

    Measured: From predose to Day 5

  3. AUClast

    Area under the plasma concentration-time curve from time 0 to last quantifiable concentration

    Measured: From predose to Day 5

  4. AUCinf

    Area under the plasma concentration-time curve from time zero to infinity

    Measured: From predose to Day 5

  5. t1/2

    Apparent terminal elimination half-life

    Measured: From predose to Day 5

  6. CL/F

    Apparent total body clearance

    Measured: From predose to Day 5

  7. Vz/F

    Apparent volume of distribution

    Measured: From predose to Day 5

  8. Vss (IV)

    Steady State Volume of distribution

    Measured: From predose to Day 5

  9. CL (IV)

    Total Body Clearance

    Measured: From predose to Day 5

  10. F

    Absolute bioavailability= ratio of the adjusted geometric means of dose normalized AUCinf for unlabeled PF-04965842 and IV labeled 14C-PF-04965842

    Measured: From predose to Day 5

  11. Fa

    Fraction of PF 04965842 dose absorbed = Total 14C urine data following both IV and oral administration of 14C PF 04965842 (quantification by AMS).

    Measured: Predose to Day Day 5

Timeline

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

  1. First posted15 Aug 2017
  2. Study start10 Jul 2017
  3. Primary completion15 Sep 2017
  4. Study completion15 Sep 2017

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
Other
Allocation
Non-randomised
Intervention model
Crossover
Model description
This study will be an open label, non randomized, 2 period, fixed sequence, single dose study to characterize the absorption, metabolism and excretion of 14C- PF-04965842 and to evaluate the absolute oral bioavailability (F) and fraction absorbed (Fa) of PF-04965842 following oral administration of unlabeled PF-04965842 and IV and oral administration of 14C-PF-04965842 to healthy male subjects.
Masking
None (open label)
Enrolment
6 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03250039
Sponsor's protocol ID
B7451008
Other IDs
2017-000461-73, 2017
Status last verified
Dec 2017
First submitted
11 Jul 2017
Last updated
21 Dec 2017
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
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

Publications

  • Bauman JN, Doran AC, King-Ahmad A, Sharma R, Walker GS, Lin J, Lin TH, Telliez JB, Tripathy S, Goosen TC, Banfield C, Malhotra BK, Dowty ME. The Pharmacokinetics, Metabolism, and Clearance Mechanisms of Abrocitinib, a Selective Janus Kinase Inhibitor, in Humans. Drug Metab Dispos. 2022 Aug;50(8):1106-1118. doi: 10.1124/dmd.122.000829. Epub 2022 Jun 14.

    PubMed 35701182

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing PF-04965842 and Absolute Bioavailability in people with Healthy, run by Pfizer at 2 sites in Netherlands.

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 29 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 21 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Netherlands. 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?

Cumulative recovery of radioactivity (time frame: From predose to Day 14 day). 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 NCT03250039, which also lists 1 linked publication.

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 21 Dec 2017.

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