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CompletedNCT07015918Updated Sep 10, 2025

A Study to Understand How the Study Medicine (PF-07976016) is Processed and Eliminated in Healthy Men

A Phase 1 interventional study of [14C] PF-07976016 and PF-07976016 in Healthy Male Volunteers, sponsored by Pfizer. Completed at 1 site in Netherlands. Open to male participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-09-10.

Sponsored by Pfizer · Phase 1, Interventional, and Basic science

From the registry’s dates

  • Primary completion was Jul 2025, 1 year 2 months ago, and no results have been posted to the registry.
Phase
Phase 1
Study type
Interventional
Enrollment
8
Allocation
Not applicable
Ages
18 Years to 65 Years
Sex
Male
01

Study summary

The purpose of this study is to learn about how much the study medicine PF-07976016 will be taken up and processed by healthy male participants. The total number of weeks of the study is up to approximately 12 weeks.

02

Conditions studied

  • Healthy Male Volunteers
03

In context

Lead sponsor

Pfizer is the lead sponsor of 3,244 studies on the registry; 139 are open to participants now.

Of its 582 completed or terminated interventional studies of FDA-regulated products, 381 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Inclusion criteria

  • Males, 18 to 65 years of age
  • BMI 17.5 to 32 kg/m2 and a total body weight >50 kg (110 lb)
  • Willing and able to comply with all study procedures

Exclusion criteria

Exclusion Criteria:

  • History of irregular bowel movements or lactose intolerance
  • Any medical or psychiatric condition or laboratory abnormality or other condition that may increase the risk of study participation
  • Use of any prohibited or concomitant medication(s)
  • Presence of specified abnormalities on diagnostic assessments including clinical laboratory tests
  • Positive urine drug test
  • History of alcohol abuse or repeated binge drinking and/or any other illicit drug use or dependence
  • Use of tobacco/nicotine containing products in excess of the equivalent of 5 cigarettes/day
  • Previous administration of an investigational product within 30 days preceding the first dose of study medicine in this study.
05

Study design

Phase
Phase 1
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
8 participants (actual)

Study arms

  • Experimental
    Arm 1

    Participants will receive doses of PF-07976016 with and without radiolabel.

    Drug: [14C] PF-07976016 · Drug: PF-07976016

Interventions

  • Drug[14C] PF-07976016

    \[14C\] PF-07976016 liquid (oral) formulation

  • DrugPF-07976016

    PF-07976016 liquid (oral) formulation

  • Drug[14C] PF-07976016

    \[14C\] PF-07976016 intravenous (IV) formulation

06

What researchers measure

Primary outcomes

  1. Total recovery of radioactivity expressed as a percent of total oral radioactive dose administered.

    Time frame: From dose (Day 1) and for up to 21 days thereafter

Secondary outcomes

  1. Number of participants with treatment emergent adverse events

    Time frame: First dose (Day 1) through 28 to 35 days after final dose (approximately 12 weeks)

07

Study locations

1 site
  • ICON
    Groningen, 9728 NZ, Netherlands
08

References and documents

Individual participant data

Plan to share: 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.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 10, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07015918
Lead sponsor
Pfizer
Responsible party
Sponsor
First posted
Jun 11, 2025
Start date
Jun 4, 2025
Primary completion
Jul 16, 2025
Completion
Aug 14, 2025
Last update
Sep 10, 2025

Study contacts

Pfizer CT.gov Call Center
study director · Pfizer

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.

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