Healthy ParticipantsPhase 1NCT06392230
A Study to Learn How the Medicine Called [14C] PF-06821497 is Taken up Into and Removed From the Body.
A Phase 1 study testing Oral [14C] PF-06821497, Oral PF-06821497 and IV [14C] PF-06821497 in people with Healthy Participants, run by Pfizer at 1 site in Netherlands.
Trial summary
The purpose of this study is to learn how a certain amount of [14C] PF-06821497 is taken up into the bloodstream and removed from the body. The study is seeking participants who are: Males aged 18 years or older. Are confirmed to be healthy after performing some medical and physical tests. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- Oral [14C] PF-06821497, Oral PF-06821497 and IV [14C] PF-06821497
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteNetherlands
- Study dates
- 30 Aug 2024to 11 Nov 2024
- 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 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male participants aged 18 years at screening who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring.
- Body mass index (BMI) of 16-32 kg/m2; and a total body weight of >50kg (110lb)
- Participants who are willing to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures
Who cannot join
- Any condition possibly affecting drug absorption (eg, gastrectomy, cholecystectomy, prior bariatric surgery, ileal resection, inflammatory gastrointestinal disease, chronic diarrhea, known diverticular disease).
- Chronic liver diseases including alcoholic liver disease, viral hepatitis, primary biliary cirrhosis, primary sclerosing cholangitis, autoimmune hepatitis, Wilson's disease, hemochromatosis, alpha-1 antitrypsin deficiency, human immunodeficiency virus, or other chronic liver disease.
- Previous administration with an investigational product (drug or vaccine) within 30 days (or as determined by the local requirement) or 5 half lives preceding the first dose of study intervention used in this study (whichever is longer). Participation in studies of other investigational products (drug or vaccine) at any time during their participation in this study.
- Total [14C] radioactivity measured in plasma at screening exceeding 11 mBq/mL
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A PHASE 1, OPEN-LABEL, FIXED-SEQUENCE, 2-PERIOD STUDY IN HEALTHY ADULT MALE PARTICIPANTS TO ASSESS THE MASS BALANCE, ABSOLUTE BIOAVAILABILITY, FRACTION ABSORBED, AND PHARMACOKINETICS OF [14C]PF-06821497 USING A 14C-MICROTRACER APPROACH
The purpose of this study is to learn how a certain amount of [14C] PF-06821497 is taken up into the bloodstream and removed from the body.
The study is seeking participants who are:
Read more
- Males aged 18 years or older.
- Are confirmed to be healthy after performing some medical and physical tests.
- Weigh more than 50 kilograms and have a body mass index of 16 to 32 kg per meter squared.
The study consists of two parts. In part one, all participants will receive one full dose of [14C]PF-06821497 by mouth. Part two will begin at least 14 days after the dose in part one. In part two participants will receive one full dose of PF-06821497 by mouth and one small dose of [14C]PF-06821497 by intravenous (IV) infusion. IV infusion will be directly injected into the veins.
To understand how the medicine is processed in the body, samples of blood, urine, and feces will be collected after each dose is given. This will help understand:
- How much PF-06821497 is taken up into the bloodstream when taken by mouth compared to the dose given by IV
- How the body removes it from the bloodstream.
Participants will take part in the study for about 11 weeks, including the initial evaluation and follow-up periods.
- Conditions
- Healthy Participants
- Being tested
- Oral [14C] PF-06821497, Oral PF-06821497, IV [14C] PF-06821497
- Keywords
- Absorption, Distribution, Metabolism, Elimination, ADME (Absorption, Distribution, Metabolism, and Excretion), Pharmacokinetics, Bioavailability, Fraction absorbed, Mass balance, Healthy Males, Enhancer of zeste homolog 2 (EZH2) inhibitor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral [14C] PF-06821497Drug
A single oral dose of [14C] PF-06821497 will be administered as an extemporaneous suspension in Period 1
Oral PF-06821497Drug
A single oral dose of PF-06821497 will be administered as an extemporaneous oral suspension in Period 2
IV [14C] PF-06821497Drug
A single IV infusion of [14C] PF-06821497 will be administered at the Tmax after administration of the unlabeled oral dose of PF-06821497 in Period 2
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | Participants will receive one dose of [14C] PF-06821497 by mouth in Period 1. After a washout, participants will receive one dose of PF-06821497 by mouth and one intravenous (IV) infusion of [14C] PF-06821497 in Period 2 Receives: Drug: Oral [14C] PF-06821497; Drug: Oral PF-06821497; Drug: IV [14C] PF-06821497 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total recovery of radioactivity in urine, feces, and total excreta (urine + feces) as percentage of total radioactive dose administered
To characterize the extent of excretion of total radioactivity in urine and feces following administration of a single oral dose of [14C]PF-06821497
Measured: Period 1 pre-dose to maximum Day 14
Metabolic profiling/identification and determination of relative abundance of [14C]PF-06821497 and the metabolites of [14C]PF-06821497 in plasma, urine, and feces
Amount of metabolites of [14C]PF-06821497 in plasma, urine, and feces
Measured: Period 1 pre-dose to maximum Day 14
Secondary outcomes (19)
Absolute oral bioavailability (F) of [14C]PF-06821497
To determine the absolute oral bioavailability (F) of PF-06821497 by comparing AUCinf following administration of a single oral dose of PF-06821497 to a single IV microtracer of [14C]PF 06821497
Measured: Period 2 pre-dose to maximum Day 5
Fraction of [14C]PF 06821497 dose absorbed (Fa)
To determine the fraction of the dose absorbed (Fa) following administration of a single oral dose of [14C]PF 06821497 from total urinary radioactivity of [14C]PF 06821497 in Period 1 and IV microtracer microdose administration of [14C]PF 06821497 in Period 2
Measured: Period 1 pre-dose to maximum Day 14; Period 2 pre-IV dose to maximum Day 5
AUClast of total radioactivity and PF-06821497 in plasma
To quantify plasma area under the concentration versus time curve (AUClast) of PF-06821497 and total radioactivity following administration of a single oral dose of [14C]PF-06821497.
Measured: Period 1 pre-dose to maximum Day 14
Cmax of total radioactivity and PF-06821497 in plasma
To quantify plasma peak concentration (Cmax) of PF-06821497 and total radioactivity following administration of a single oral dose of [14C]PF-06821497.
Measured: Period 1 pre-dose to maximum Day 14
Tmax of total radioactivity and PF-06821497 in plasma
To quantify plasma time of peak concentration (Tmax) of PF-06821497 and total radioactivity following administration of a single oral dose of [14C]PF-06821497.
Measured: Period 1 pre-dose to maximum Day 14
AUCinf of total radioactivity and PF-06821497 in plasma
If data permits, to quantify plasma area under the concentration versus time curve extrapolated to infinity (AUCinf) of PF-06821497 and total radioactivity following administration of a single oral dose of [14C]PF-06821497.
Measured: Period 1 pre-dose to maximum Day 14
t½ of total radioactivity and PF-06821497 in plasma
If data permits, to quantify plasma half-life (t½) of PF-06821497 and total radioactivity following administration of a single oral dose of [14C]PF-06821497.
Measured: Period 1 pre-dose to maximum Day 14
AUClast of [14C]PF-06821497 in plasma
To quantify plasma area under the concentration versus time curve (AUClast) of PF-06821497 following administration of a single, IV, microtracer of [14C]PF-06821497.
Measured: Period 2 pre-dose to maximum Day 5
Cmax of [14C]PF-06821497 in plasma
To quantify plasma peak concentration (Cmax) of PF-06821497 following administration of a single, IV, microtracer of [14C]PF-06821497.
Measured: Period 2 pre-dose to maximum Day 5
Tmax of [14C]PF-06821497 in plasma
To quantify plasma time of peak concentration (Tmax) of PF-06821497 following administration of a single, IV, microtracer of [14C]PF-06821497.
Measured: Period 2 pre-dose to maximum Day 5
t½ of [14C]PF-06821497 in plasma
If data permits, to quantify plasma half-life (t½) of PF-06821497 following administration of a single, IV, microtracer of [14C]PF-06821497.
Measured: Period 2 pre-dose to maximum Day 5
AUCinf of [14C]PF-06821497 in plasma
If data permits, to quantify plasma area under the concentration versus time curve extrapolated to infinity (AUCinf) of PF-06821497 following administration of a single, IV, microtracer of [14C]PF-06821497.
Measured: Period 2 pre-dose to maximum Day 5
CL of [14C]PF-06821497 in plasma
If data permits, to quantify plasma clearance (CL) of PF-06821497 following administration of a single, IV, microtracer of [14C]PF-06821497.
Measured: Period 2 pre-dose to maximum Day 5
Vss of [14C]PF-06821497 in plasma
If data permits, to quantify plasma volume of distribution at steady-state (Vss) of PF-06821497 following administration of a single, IV, microtracer of [14C]PF-06821497.
Measured: Period 2 pre-dose to maximum Day 5
Number of participants with treatment emergent clinically significant laboratory abnormalities
Measured: Both cohorts from pre-dose to 28 days post-dose
Number of participants with treatment emergent clinically significant abnormal ECG measurements
Measured: Both cohorts from pre-dose to 28 days post-dose
Number of participants with treatment emergent clinically significant abnormal vital measurements
Measured: Both cohorts from pre-dose to 28 days post-dose
Number of participants with treatment emergent clinically significant abnormal physical examination
Measured: Both cohorts from pre-dose to 28 days post-dose
Number of participants with treatment-emergent adverse events (AEs) or serious adverse events (SAEs)
Measured: Both cohorts from pre-dose to 28 days post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2024
- Study start30 Aug 2024
- Primary completion11 Nov 2024
- Study completion11 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy ParticipantsStudies 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
- 6 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
- NCT06392230
- Sponsor's protocol ID
- C2321007
- Other IDs
- 2023-508371-36-00, 2023
- Status last verified
- Jan 2025
- First submitted
- 12 Apr 2024
- Last updated
- 23 Jan 2025
- Results posted
- No
- FDA-regulated drug
- No
- 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 23 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A PHASE 1, OPEN-LABEL, FIXED-SEQUENCE, 2-PERIOD STUDY IN HEALTHY ADULT MALE PARTICIPANTS TO ASSESS THE MASS BALANCE, ABSOLUTE BIOAVAILABILITY, FRACTION ABSORBED, AND PHARMACOKINETICS OF [14C]PF-06821497 USING A 14C-MICROTRACER APPROACH
- ClinicalTrials.gov ID
- NCT06392230
- Acronym / sponsor ID
- C2321007
- Conditions
- Healthy Participants
- Keywords
- Absorption, Distribution, Metabolism, Elimination, ADME (Absorption, Distribution, Metabolism, and Excretion), Pharmacokinetics, Bioavailability, Fraction absorbed
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 30 Aug 2024 (actual)
- Primary completion
- 11 Nov 2024 (actual)
- Study completion
- 11 Nov 2024 (actual)
- First posted
- 30 Apr 2024 (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 how a certain amount of [14C] PF-06821497 is taken up into the bloodstream and removed from the body.
The study is seeking participants who are:
- Males aged 18 years or older.
- Are confirmed to be healthy after performing some medical and physical tests.
- Weigh more than 50 kilograms and have a body mass index of 16 to 32 kg per meter squared.
The study consists of two parts. In part one, all participants will receive one full dose of [14C]PF-06821497 by mouth. Part two will begin at least 14 days after the dose in part one. In part two participants will receive one full dose of PF-06821497 by mouth and one small dose of [14C]PF-06821497 by intravenous (IV) infusion. IV infusion will be directly injected into the veins.
To understand how the medicine is processed in the body, samples of blood, urine, and feces will be collected after each dose is given. This will help understand:
- How much PF-06821497 is taken up into the bloodstream when taken by mouth compared to the dose given by IV
- How the body removes it from the bloodstream.
Participants will take part in the study for about 11 weeks, including the initial evaluation and follow-up periods.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: Oral [14C] PF-06821497, Drug: Oral PF-06821497, Drug: IV [14C] PF-06821497Participants will receive one dose of [14C] PF-06821497 by mouth in Period 1. After a washout, participants will receive one dose of PF-06821497 by mouth and one intravenous (IV) infusion of [14C] PF-06821497 in Period 2 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male participants aged 18 years at screening who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring.
- Body mass index (BMI) of 16-32 kg/m2; and a total body weight of >50kg (110lb)
- Participants who are willing to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures
Key exclusion criteria (4 listed)
- Any condition possibly affecting drug absorption (eg, gastrectomy, cholecystectomy, prior bariatric surgery, ileal resection, inflammatory gastrointestinal disease, chronic diarrhea, known diverticular disease).
- Chronic liver diseases including alcoholic liver disease, viral hepatitis, primary biliary cirrhosis, primary sclerosing cholangitis, autoimmune hepatitis, Wilson's disease, hemochromatosis, alpha-1 antitrypsin deficiency, human immunodeficiency virus, or other chronic liver disease.
- Previous administration with an investigational product (drug or vaccine) within 30 days (or as determined by the local requirement) or 5 half lives preceding the first dose of study intervention used in this study (whichever is longer). Participation in studies of other investigational products (drug or vaccine) at any time during their participation in this study.
- Total [14C] radioactivity measured in plasma at screening exceeding 11 mBq/mL
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 |
|---|---|---|
| Oral [14C] PF-06821497A single oral dose of [14C] PF-06821497 will be administered as an extemporaneous suspension in Period 1 | Drug | Cohort 1 |
| Oral PF-06821497A single oral dose of PF-06821497 will be administered as an extemporaneous oral suspension in Period 2 | Drug | Cohort 1 |
| IV [14C] PF-06821497A single IV infusion of [14C] PF-06821497 will be administered at the Tmax after administration of the unlabeled oral dose of PF-06821497 in Period 2 | Drug | Cohort 1 |
Primary outcome
Total recovery of radioactivity in urine, feces, and total excreta (urine + feces) as percentage of total radioactive dose administered
Time frame: Period 1 pre-dose to maximum Day 14
To characterize the extent of excretion of total radioactivity in urine and feces following administration of a single oral dose of [14C]PF-06821497
Metabolic profiling/identification and determination of relative abundance of [14C]PF-06821497 and the metabolites of [14C]PF-06821497 in plasma, urine, and feces
Time frame: Period 1 pre-dose to maximum Day 14
Amount of metabolites of [14C]PF-06821497 in plasma, urine, and feces
19 secondary outcomes
Absolute oral bioavailability (F) of [14C]PF-06821497
Time frame: Period 2 pre-dose to maximum Day 5
Fraction of [14C]PF 06821497 dose absorbed (Fa)
Time frame: Period 1 pre-dose to maximum Day 14; Period 2 pre-IV dose to maximum Day 5
AUClast of total radioactivity and PF-06821497 in plasma
Time frame: Period 1 pre-dose to maximum Day 14
Cmax of total radioactivity and PF-06821497 in plasma
Time frame: Period 1 pre-dose to maximum Day 14
Tmax of total radioactivity and PF-06821497 in plasma
Time frame: Period 1 pre-dose to maximum Day 14
AUCinf of total radioactivity and PF-06821497 in plasma
Time frame: Period 1 pre-dose to maximum Day 14
t½ of total radioactivity and PF-06821497 in plasma
Time frame: Period 1 pre-dose to maximum Day 14
AUClast of [14C]PF-06821497 in plasma
Time frame: Period 2 pre-dose to maximum Day 5
Cmax of [14C]PF-06821497 in plasma
Time frame: Period 2 pre-dose to maximum Day 5
Tmax of [14C]PF-06821497 in plasma
Time frame: Period 2 pre-dose to maximum Day 5
t½ of [14C]PF-06821497 in plasma
Time frame: Period 2 pre-dose to maximum Day 5
AUCinf of [14C]PF-06821497 in plasma
Time frame: Period 2 pre-dose to maximum Day 5
CL of [14C]PF-06821497 in plasma
Time frame: Period 2 pre-dose to maximum Day 5
Vss of [14C]PF-06821497 in plasma
Time frame: Period 2 pre-dose to maximum Day 5
Number of participants with treatment emergent clinically significant laboratory abnormalities
Time frame: Both cohorts from pre-dose to 28 days post-dose
Number of participants with treatment emergent clinically significant abnormal ECG measurements
Time frame: Both cohorts from pre-dose to 28 days post-dose
Number of participants with treatment emergent clinically significant abnormal vital measurements
Time frame: Both cohorts from pre-dose to 28 days post-dose
Number of participants with treatment emergent clinically significant abnormal physical examination
Time frame: Both cohorts from pre-dose to 28 days post-dose
Number of participants with treatment-emergent adverse events (AEs) or serious adverse events (SAEs)
Time frame: Both cohorts from pre-dose to 28 days post-dose
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 23 Jan 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.
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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 Oral [14C] PF-06821497, Oral PF-06821497 and IV [14C] PF-06821497 in people with Healthy Participants, 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 4 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 23 Jan 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 in urine, feces, and total excreta (urine + feces) as percentage of total radioactive dose administered (time frame: Period 1 pre-dose to maximum Day 14). 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?
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 23 Jan 2025.