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Healthy Male SubjectsPhase 1NCT03770039

Single Dose Study With Unlabeled Dose and 14C-labeled Microdose of PF-06700841 in Healthy Male Subjects

A Phase 1 study testing Oral PF-06700841 containing 14C microtracer, Oral unlabeled PF-06700841 and IV 14C-labeled PF-06700841 in people with Healthy Male Subjects, 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

An open-label, fixed sequence, 2-period including a single oral dose 60 mg PF-06700841 with 14C-labeled microtracer in 1st period, and a single oral dose of 60 mg unlabeled PF-06700841 followed by intravenous administration of 14C-labeled microdose of PF-06700841 1 hour after oral dose in period 2 to characterize the… 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 Male Subjects
What is being tested?
Oral PF-06700841 containing 14C microtracer, Oral unlabeled PF-06700841 and IV 14C-labeled PF-06700841
Could I receive a placebo?
No, everyone receives an active treatment
How many people
6 participants
Where
2 sitesNetherlands
Study dates
10 Dec 2018to 21 Feb 2019
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

None listed.

Who cannot join

  • Any clinically significant malabsorption condition (eg, gastrectomy, bowel resection).
  • Total 14C radioactivity measured in plasma exceeding 11 mBq/mL
  • History of tuberculosis or active or latent or inadequately treated infection, positive QuantiFERON®-TB Gold test
  • Use of tobacoo/nicotine containing products 3-m prior to dosing or positive urine cotinine test
  • Use of herbal supplements within 28 days prior to the first dose of study medication
  • 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
  • Inability to have at least one bowel movement every 2 days on average eGFR of <90 mL/mim/1.73 m2 based on MDRD equation
  • Have been vaccinated with live or attenuated live vaccine within the 6 weeks prior to the first dose of investigational product, or expects to be vaccinated with these vaccines during study treatment, or within the 6 weeks following the last dose of investigational product.

Trial locations and contacts

2 sites in 1 country.

Netherlands2 sites

  • PRA Health Sciences

    Groningen, 9728 NZ

  • PRA Health Sciences Utrecht

    Utrecht, 3584 BL

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, DISTRIBUTION, METABOLISM AND EXCRETION OF [14C-PF-06700841] AND TO ASSESS THE ABSOLUTE BIOAVAILABILITY AND FRACTION ABSORBED OF PF-06700841 IN HEALTHY MALE SUBJECTS USING A 14C-MICROTRACER APPROACH

An open-label, fixed sequence, 2-period including a single oral dose 60 mg PF-06700841 with 14C-labeled microtracer in 1st period, and a single oral dose of 60 mg unlabeled PF-06700841 followed by intravenous administration of 14C-labeled microdose of PF-06700841 1 hour after oral dose in period 2 to characterize the absorption, disposition, metabolism and excretion of PF-06700841 and evaluate the absolute bioavailability and fraction absorbed in the GI tract

Being tested
Oral PF-06700841 containing 14C microtracer, Oral unlabeled PF-06700841, IV 14C-labeled PF-06700841
Keywords
PF-06700841, mass balance, metabolites, absolute bioavailability

What participants receive

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

  • Oral PF-06700841 containing 14C microtracerDrug

    Oral dose of 60 mg unlabeled PF-06700841 co-formulated with 30 ug 14C-labeled (300 nCi) PF-06700841 in 1st period

  • Oral unlabeled PF-06700841Drug

    60 mg unlabeled PF-06700841 oral dose in 2nd period

  • IV 14C-labeled PF-06700841Drug

    30 ug 14C-labeled (300 nCi) PF-06700841 intravenous infusion over 5 min in 2nd period

Study groups in NCT03770039
Study groupRoleWhat they receive
2-period, fixed sequenceExperimentalfixed sequence with 2 treatment period
Receives: Drug: Oral PF-06700841 containing 14C microtracer; Drug: Oral unlabeled PF-06700841; Drug: IV 14C-labeled PF-06700841

What is being measured

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

  1. mass balance_urine

    cumulative recovery of radioactivity over time in urine, as percentage of total radioactive dose administered

    Measured: hour 0 up to 312 hours post dose

  2. mass balance_feces

    cumulative recovery of radioactivity over time in feces, as percentage of total radioactive dose administered

    Measured: hour 0 up to 312 hours post dose

Secondary outcomes (28)

  1. metabolite identification_plasma

    metabolic identification and profiling in plasma following a single oral dose of 14C-labeled PF-06700841

    Measured: hour 0 up to 312 hours post dose

  2. plasma Cmax for total 14C radioactivity

    maximum concentration of total 14C radioactivity in plasma following a single oral dose of 14C-labeled PF-06700841

    Measured: hour 0 up to 312 hours post dose

  3. plasma Tmax for total 14C radioactivity

    time with highest concentration of radioactivity in plasma following a single oral dose of 14C-labeled PF-06700841

    Measured: hour 0 up to 312 hours post dose

  4. plasma AUClast for total 14C radioactivity

    area under curve of total 14C radioactivity in plasma from time 0 to tlast following a single oral dose of 14C-labeled PF-06700841

    Measured: hour 0 up to 312 hours post dose

  5. plasma AUCinf for total 14C radioactivity

    area under curve of total 14C radioactivity in plasma from time 0 to infinite following a single oral dose of 14C-labeled PF-06700841

    Measured: hour 0 up to 312 hours post dose

  6. Oral clearance for total 14C radioactivity

    oral clearance (CL/F) of total activity following a single oral dose of 14C-labeled PF-06700841

    Measured: hour 0 up to 312 hours post dose

  7. plasma half-life for total 14C radioactivity

    half-life (t1/2) of total radioactivity in plasma following a single oral dose of 14C-labeled PF-06700841

    Measured: hour 0 up to 312 hours post dose

  8. volume of distribution for total 14C radioactivity

    apparent volume of distribution (Vz/F) of total radioactivity following a single oral dose of 14C-labeled PF-06700841

    Measured: hour 0 up to 312 hours post dose

  9. plasma Cmax for PF-06700841

    maximum concentration of PF-06700841 in plasma following a single oral dose of 14C-labeled or unlabeled PF-06700841

    Measured: hour 0 up to 96 hours post dose

  10. plasma Tmax for PF-06700841

    time with highest concentration of PF-06700841 in plasma following a single oral dose of 14C-labeled or unlabeled PF-06700841

    Measured: hour 0 up to 96 hours post dose

  11. plasma AUClast for PF-06700841

    area under curve of PF-06700841 in plasma from time 0 to tlast following a single oral dose of 14C-labeled or unlabeled PF-06700841

    Measured: hour 0 up to 96 hours post dose

  12. plasma AUCinf for PF-06700841

    area under curve of PF-06700841 in plasma from time 0 to infinite following a single oral dose of 14C-labeled or unlabeled PF-06700841

    Measured: hour 0 up to 96 hours post dose

  13. Oral clearance for PF-06700841

    oral clearance (CL/F) of PF-06700841 following a single oral dose of 14C-labeled or unlabeled PF-06700841

    Measured: hour 0 up to 96 hours post dose

  14. plasma half-life for PF-06700841

    half-life (t1/2) of PF-06700841 in plasma following a single oral dose of 14C-labeled or unlabeled PF-06700841

    Measured: hour 0 up to 96 hours post dose

  15. volume of distribution for PF-06700841

    apparent volume of distribution (Vz/F) of PF-06700841 following a single oral dose of 14C-labeled or unlabeled PF-06700841

    Measured: hour 0 up to 96 hours post dose

  16. plasma Cmax for 14C-labeled PF-06700841

    maximum concentration of 14C-labeled PF-06700841 in plasma following a single iv dose of 14C-labeled PF-06700841

    Measured: hour 0 up to 96 hours post dose

  17. plasma Tmax for 14C-labeled PF-06700841

    time with highest concentration of 14C-labeled PF-06700841 in plasma following a single iv dose of 14C-labeled PF-06700841

    Measured: hour 0 up to 96 hours post dose

  18. plasma AUClast for 14C-labeled PF-06700841

    area under curve of 14C-labeled PF-06700841 in plasma from time 0 to tlast following a single iv dose of 14C-labeled PF-06700841

    Measured: hour 0 up to 96 hours post dose

  19. plasma AUCinf for 14C-labeled PF-06700841

    area under curve of 14C-PF-06700841 in plasma from time 0 to infinite following a single iv dose of 14C-labeled PF-06700841

    Measured: hour 0 up to 96 hours post dose

  20. clearance for 14C-labeled PF-06700841

    clearance (CL) of 14C-labeled PF-06700841 following a single iv dose of 14C-labeled PF-06700841

    Measured: hour 0 up to 96 hours post dose

  21. plasma half-life for 14C-labeled PF-06700841

    half-life (t1/2) of 14C-labeled PF-06700841 in plasma following a single iv dose of 14C-labeled PF-06700841

    Measured: hour 0 up to 96 hours post dose

  22. volume of distribution for 14C-labeled PF-06700841

    volume of distribution (Vz/F) of 14C-labeled PF-06700841 following a single iv dose of 14C-labeled PF-06700841

    Measured: hour 0 up to 96 hours post dose

  23. unchanged PF-06700841 recovered in urine

    percentage of unchanged PF-06700841 recovered in urine (Ae%) following a single oral dose of PF-06700841

    Measured: hour 0 up to 96 hours post dose

  24. renal clearance of PF-06700841

    renal clearance (CLr) following a single oral dose of PF-06700841 (Ae%/AUCinf for PF-06700841)

    Measured: hour 0 up to 96 hours post dose

  25. Bioavailability of oral PF-06700841

    Absolute bioavailability (F) following a single oral dose relative to a single iv dose of PF-06700841

    Measured: hour 0 up to 96 hours post dose

  26. Fraction absorbed of oral PF-06700841

    Fraction absorbed in gut (Fa) following oral dose of PF-06700841

    Measured: hour 0 up to 144 hours post dose

  27. metabolite identification_urine

    metabolic identification and profiling in urine following a single oral dose of 14C-labeled PF-06700841

    Measured: hour 0 up to 312 hours post dose

  28. metabolite identification_feces

    metabolic identification and profiling in feces following a single oral dose of 14C-labeled PF-06700841

    Measured: hour 0 up to 312 hours post dose

Timeline

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

  1. First posted10 Dec 2018
  2. Study start10 Dec 2018
  3. Primary completion21 Feb 2019
  4. Study completion21 Feb 2019

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
Non-randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
6 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03770039
Sponsor's protocol ID
B7931014
Other IDs
2018-002403-34, 2018
Status last verified
Mar 2019
First submitted
6 Dec 2018
Last updated
6 Mar 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.

Publications

  • Bauman JN, Doran AC, Gualtieri GM, Hee B, Strelevitz T, Cerny MA, Banfield C, Plotka A, Wang X, Purohit VS, Dowty ME. The Pharmacokinetics, Metabolism, and Clearance Mechanisms of Ritlecitinib, a Janus Kinase 3 and Tyrosine-Protein Kinase Family Inhibitor, in Humans. Drug Metab Dispos. 2024 Sep 16;52(10):1124-1136. doi: 10.1124/dmd.124.001843.

    PubMed 39111823

  • Qiu R, Sharma R, Wei H, Kirkovsky L, Zhou Y, Martin DDA, Banfield C, Dowty ME. A phase 1 study to investigate the absorption, distribution, metabolism and excretion of brepocitinib in healthy males using a 14 C-microdose approach. Br J Clin Pharmacol. 2023 Oct;89(10):3056-3066. doi: 10.1111/bcp.15786. Epub 2023 Jun 20.

    PubMed 37183779

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Oral PF-06700841 containing 14C microtracer, Oral unlabeled PF-06700841 and IV 14C-labeled PF-06700841 in people with Healthy Male Subjects, 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 0 inclusion and 8 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 6 Mar 2019. 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?

mass balance_urine (time frame: hour 0 up to 312 hours post dose). The study lists 2 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 NCT03770039, which also lists 2 linked publications.

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 6 Mar 2019.

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