Healthy Male VolunteersPhase 1NCT07015918
A Study to Understand How the Study Medicine (PF-07976016) is Processed and Eliminated in Healthy Men
A Phase 1 study testing [14C] PF-07976016 and PF-07976016 in people with Healthy Male Volunteers, run by Pfizer at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Male Volunteers
- What is being tested?
- [14C] PF-07976016 and PF-07976016
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteNetherlands
- Study dates
- 4 Jun 2025to 14 Aug 2025
- 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 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A PHASE 1, OPEN-LABEL, 2-PERIOD, FIXED-SEQUENCE STUDY TO INVESTIGATE THE ABSORPTION, DISTRIBUTION, METABOLISM, AND EXCRETION OF [14C]PF-07976016 AND TO ASSESS THE ABSOLUTE BIOAVAILABILITY AND FRACTION ABSORBED OF PF-07976016 IN HEALTHY MALE PARTICIPANTS USING A [14C]-MICROTRACER APPROACH
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.
- Conditions
- Healthy Male Volunteers
- Being tested
- [14C] PF-07976016, PF-07976016
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[14C] PF-07976016Drug
[14C] PF-07976016 liquid (oral) formulation
PF-07976016Drug
PF-07976016 liquid (oral) formulation
[14C] PF-07976016Drug
[14C] PF-07976016 intravenous (IV) formulation
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Participants will receive doses of PF-07976016 with and without radiolabel. Receives: Drug: [14C] PF-07976016; Drug: PF-07976016 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total recovery of radioactivity expressed as a percent of total oral radioactive dose administered.
Measured: From dose (Day 1) and for up to 21 days thereafter
Secondary outcomes (1)
Number of participants with treatment emergent adverse events
Measured: First dose (Day 1) through 28 to 35 days after final dose (approximately 12 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2025
- Study start4 Jun 2025
- Primary completion16 Jul 2025
- Study completion14 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Male VolunteersStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07015918
- Sponsor's protocol ID
- C5541002
- Other IDs
- 2024-518535-11-00
- Status last verified
- Sep 2025
- First submitted
- 3 Jun 2025
- Last updated
- 10 Sep 2025
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A PHASE 1, OPEN-LABEL, 2-PERIOD, FIXED-SEQUENCE STUDY TO INVESTIGATE THE ABSORPTION, DISTRIBUTION, METABOLISM, AND EXCRETION OF [14C]PF-07976016 AND TO ASSESS THE ABSOLUTE BIOAVAILABILITY AND FRACTION ABSORBED OF PF-07976016 IN HEALTHY MALE PARTICIPANTS USING A [14C]-MICROTRACER APPROACH
- ClinicalTrials.gov ID
- NCT07015918
- Acronym / sponsor ID
- C5541002
- Conditions
- Healthy Male Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 4 Jun 2025 (actual)
- Primary completion
- 16 Jul 2025 (actual)
- Study completion
- 14 Aug 2025 (actual)
- First posted
- 11 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: [14C] PF-07976016, Drug: PF-07976016Participants will receive doses of PF-07976016 with and without radiolabel. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| [14C] PF-07976016[14C] PF-07976016 liquid (oral) formulation | Drug | Arm 1 |
| PF-07976016PF-07976016 liquid (oral) formulation | Drug | Arm 1 |
| [14C] PF-07976016[14C] PF-07976016 intravenous (IV) formulation | Drug | Arm 1 |
Primary outcome
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
1 secondary outcome
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2025.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
- Individual participant dataSharing planned: 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.
Related trials for Healthy Male Volunteers
RecruitingObservational study
Urinary Vitamin C Loss in Diabetic Subjects
Diabetes
Not yet recruitingPhase 2
Effects of Meal Macronutrients on Postprandial Lipids
Nephrotic Syndrome, Lipodystrophy
Not yet recruitingPhase 1
The Mass Balance Recovery, Metabolite Profile and Metabolite Identification of [14C]OD-001 in Healthy Male Participants
Health Volunteers
RecruitingPhase 1/2
Vasopressin and Pain Perception in the Brain
Acute Pain
RecruitingPhase 1/2
Study of ABS-201 Evaluating Single and Multiple Ascending Doses in Adults With and Without Androgenetic Alopecia
Androgenetic Alopecia (AGA), Healthy Volunteers - Male and Female
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing [14C] PF-07976016 and PF-07976016 in people with Healthy Male Volunteers, run by Pfizer at 1 site 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 3 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 10 Sep 2025. 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 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?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Sep 2025.