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NCT04866225 · ClinicalTrials.gov registry record · Phase 1

A Study in Healthy Adult Male Participants to Assess Absorption, Distribution, Metabolism and Excretion (ADME) of Radiolabeled PF-06865571.

A Phase 1 study, sponsored by Pfizer.

Completed
Registry status
Phase 1
Development phase
6
Enrollment target

NCT04866225: Completed Phase 1 study, sponsored by Pfizer.

NCT04866225 is a Phase 1 study that has completed, run by Pfizer. The registered enrollment target is 6 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04866225, a Phase 1 study, has completed, sponsored by Pfizer.

COMPLETED
Registry status
Phase 1
Development phase
6 participants
Enrollment target

Study Summary

This study is a Phase 1, open-label, non-randomized, 2-period, fixed-sequence, single-dose study of PF-06865571 in healthy male participants to characterize the ADME properties of \[14C\]PF-06865571 following oral administration; and to evaluate the absolute oral bioavailability (F) and fraction absorbed (Fa) of PF-06865571 following oral administration of unlabeled PF-06865571 and IV administration of \[14C\]PF-06865571.

Primary Outcome

The total recovery of radioactivity in urine was listed and summarized using descriptive statistics. In this outcome measure, the percentages of dose excreted in urine in Period 1 and Period 2 were reported.

Interventions

  • DRUG Oral [14C]PF-06865571
  • DRUG Oral PF-06865571
  • DRUG IV [14C]PF-06865571

Trial Details

FieldValue
Enrollment Target 6 participants
Start Date 2021-05-11
Est. Completion 2021-08-06
Phase Phase 1
Pfizer

1,845 total trials

What the finished NCT04866225 record still lists

NCT04866225 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 6 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (90% lower).

The record links to 0 conditions, and to 3 interventions - of which Oral [14C]PF-06865571 is the first listed.

NCT04866225 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04866225 about?

NCT04866225 is a clinical study titled "A Study in Healthy Adult Male Participants to Assess Absorption, Distribution, Metabolism and Excretion (ADME) of Radiolabeled PF-06865571.". This study is a Phase 1, open-label, non-randomized, 2-period, fixed-sequence, single-dose study of PF-06865571 in healthy male participants to characterize the ADME properties of \[14C\]PF-06865571 following oral administration; and to evaluate the absolute oral bioavailability (F) and fraction abs...

What is the current status of trial NCT04866225?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 6 participants. The study started on 2021-05-11. Estimated completion is 2021-08-06.

What interventions are being tested in trial NCT04866225?

The interventions under investigation include: Oral [14C]PF-06865571 (DRUG), Oral PF-06865571 (DRUG), IV [14C]PF-06865571 (DRUG).

Who is sponsoring clinical trial NCT04866225?

This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT04866225's enrollment target sits among peer trials

6 1974th of 2000 higher than 12 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT04866225, the US trial registry maintained by the National Library of Medicine. NCT04866225 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.