Healthy ParticipantsPhase 1NCT06267963
A Study to Understand What the Body Does to the Study Medicine Called PF-07220060 When Taken by Healthy Adults
A Phase 1 study testing Oral [14C]PF-07220060, Oral PF-07220060 and IV [14C] PF-07220060 in people with Healthy Participants, run by Pfizer at 1 site in Netherlands.
Trial summary
The purpose of this study is to learn about how much PF-07220060 will be taken up and processed by healthy male participants. The study is seeking for participants who: are males aged 18 to 65 years and are healthy. 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 Participants
- What is being tested?
- Oral [14C]PF-07220060, Oral PF-07220060 and IV [14C] PF-07220060
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteNetherlands
- Study dates
- 31 Jan 2024to 12 Apr 2024
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Male participants aged 18 to 65 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 17.5-30.5 kg/m2; and a total body weight >50 kg (110 lb).
- Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.
Who cannot join
- Participants with a history of irregular bowel movements (eg, regular episodes of diarrhea or constipation, irritable bowel syndrome [IBS] or lactose intolerance).
- Previous administration with an investigational product (drug or vaccine) within 30 days (or as determined by the local requirement) or 5 half-lives (whichever is longer) preceding the first dose of study intervention used in this study. Previous exposure to PF-07220060 or participation in studies requiring PF-07220060 administration.
- Total 14C radioactivity measured in plasma exceeding 11 mBq/mL.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A PHASE 1, OPEN-LABEL, PARALLEL-GROUP, SINGLE-DOSE STUDY IN HEALTHY ADULT MALE PARTICIPANTS TO INVESTIGATE THE ABSORPTION, DISTRIBUTION, METABOLISM AND EXCRETION OF [14C]-PF-07220060 AND TO ASSESS THE ABSOLUTE BIOAVAILABILITY AND FRACTION ABSORBED OF PF-07220060 USING A 14C-MICROTRACER APPROACH
The purpose of this study is to learn about how much PF-07220060 will be taken up and processed by healthy male participants.
The study is seeking for participants who:
Read more
- are males aged 18 to 65 years and are healthy.
- have Body mass index (BMI) between 17.5 and 30.5 kilograms/meter2
- have a total body weight of at least 50 kilograms.
The study consists of two groups. In group 1, participants will take one amount of PF-07220060 by mouth. In group 2, participants will take one amount by mouth and one amount as an injection through a vein at the study clinic.
In group 1, participants will stay at the clinic site for up to 15 days. In group 2, the duration of participants' stay depends on the results of group 1.
During their stays, participants will have their blood, urine, and feces collected by the study doctors several times. We will measure the level of PF-07220060 in participants' blood, urine, and feces samples. This will help to know how much the study medicine is getting taken up by the body. At the end of the study, participants will be contacted by phone to check in. Participants will be involved in this study for about 9 weeks from the screening until the follow-up.
- Conditions
- Healthy Participants
- Being tested
- Oral [14C]PF-07220060, Oral PF-07220060, IV [14C] PF-07220060
- Keywords
- Absorption, Distribution, Metabolism, Elimination, ADME (Absorption, Distribution, Metabolism and Excretion), Pharmacokinetics, Bioavailability, Fraction absorbed, Mass balance, Healthy Males, Cyclin-Dependent Kinase 4 (CDK4) inhibitor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral [14C]PF-07220060Drug
A single oral dose of [14C]PF-07220060, will be administered as a liquid formulation in Cohort 1.
Oral PF-07220060Drug
A single oral dose of PF-07220060, will be administered as a liquid formulation in Cohort 2.
IV [14C] PF-07220060Drug
A single IV infusion of [14C]PF-07220060 will be administered in Cohort 2 at Tmax after the administration of the unlabeled oral dose.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | Participants will receive one dose of [14C] PF-07220060 by mouth Receives: Drug: Oral [14C]PF-07220060 |
| Cohort 2 | Experimental | Participants will take one dose of PF-07220060 by mouth and one dose as an IV (intravenous) infusion of [14C] PF-07220060. Receives: Drug: Oral PF-07220060; Drug: IV [14C] PF-07220060 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Total Radiocarbon (14C) Excreted in Urine
Percentage of 14C excreted in urine following 14C PF-07220060 dose administration was determined as: (total 14C urine/ 14C dose administered)*100 where, 14C dose was administered dose of 14C PF-07220060.
Measured: From Predose up to 14 days post-dose
Percentage of Total Radiocarbon (14C) Excreted in Feces: Cohort 1
Percentage of 14C excreted in feces following 14C PF-07220060 oral dose administration was determined as: (total 14C feces/ 14C oral dose administered)*100 where, 14C dose was administered dose of 14C PF-07220060.
Measured: From Predose up to 14 days post-dose
Cumulative Percent Recovery of Total Radiocarbon (14C)
Percentage recovery of total radioactivity (14C ) in urine and feces was determined based on total administered dose.
Measured: From Predose up to 14 days post-dose
Percentage of Metabolite Detected in Plasma After Oral Administration of PF-07220060: Cohort 1
The percentage of five major metabolites detected in plasma after oral administration of PF-07220060: 480a, 480b, 496a, M3 and 496b are reported in this outcome measure. The processed samples were analyzed by liquid chromatography mass spectrometry- accelerator mass spectrometry (LC-MS-AMS). For calculation of metabolite percentage of total plasma radioactivity (RA), first composite time-normalized human plasma pools were prepared for each participant from plasma samples collected from 0-96 hours post-dose (i.e., a hamilton pool). Next, a multi-subject pool was created by combining equal volumes of each of the above individual participant pools. Results presented here are the single value output from these individual pooled multi-subject time-normalized samples.
Measured: From Predose up to 96 hours post-dose
Percentage of Metabolite Detected in Urine After Oral Administration of PF-07220060: Cohort 1
The percentage of five major metabolites detected in urine after oral administration of PF-07220060: 480a, 480b, 496a, M3 and 496b are reported in this outcome measure. The processed samples were analyzed by LC-MS-AMS. For calculation of percentage of metabolites, first composite time-normalized human urine pools were prepared for each participant from urine samples collected from 0-144 hours post-dose (i.e., a hamilton pool). Next, a multi-subject pool was created by combining equal volumes of each of the above individual participant pools. Results presented here are the single value output from these individual pooled multi-subject time-normalized samples.
Measured: From Predose up to 144 hours post-dose
Percentage of Metabolite Detected in Feces After Oral Administration of PF-07220060: Cohort 1
The percentage of five major metabolites detected in feces after oral administration of PF-07220060: 480a, 480b, 496a, M3 and 496b are reported in this outcome measure. The processed samples were analyzed by LC-MS-AMS. For calculation of percentage of metabolites, first composite time-normalized human fecal homogenate pools were prepared for each participant from fecal samples collected from 0-196 hours post-dose (i.e., a hamilton pool). Next, a multi-subject pool was created by combining equal volumes of each of the above individual participant pools. Results presented here are the single value output from these individual pooled multi-subject time-normalized samples.
Measured: From Predose up to 196 hours post-dose
Percentage of Metabolite Detected in Feces After IV Administration of PF-07220060: Cohort 2
The percentage of five major metabolites detected in feces after IV administration of PF-07220060: 480a, 480b, 496a, M3 and 496b are reported in this outcome measure. The processed samples were analyzed by LC-MS-AMS. For calculation of percentage of metabolites, first composite time-normalized human fecal homogenate pools were prepared for each participant from fecal samples collected from 0-196 hours post-dose (i.e., a hamilton pool). Next, a multi-subject pool was created by combining equal volumes of each of the above individual participant pools. Results presented here are the single value output from these individual pooled multi-subject time-normalized samples.
Measured: From Predose up to 196 hours post-dose
Secondary outcomes (6)
Absolute Oral Bioavailability for Plasma Dose-Normalized Area Under the Curve (AUC)Infinity: Cohort 2
Dose normalized AUCinf (AUCinf[dn]) was calculated as AUCinf/Dose, where AUCinf was the area under the plasma concentration-time profile from time 0 extrapolated to infinite time. Absolute oral bioavailability was defined as the ratio of geometric mean of AUCinf(dn) following orally administered PF-07220060 (i.e., unlabeled PF-07220060) to AUCinf(dn) following intravenously administered [14C]PF-07220060 and reported in the statistical analysis section.
Measured: From Predose up to 14 days post-dose
Cohort 1 and 2: Fraction of PF-07220060 Dose Absorbed (Fa)
Fraction of dose absorbed (Fa) was estimated as the ratio of total radioactivity (dose normalized) excreted into the urine (from time 0 to the time of last measurable concentration) following oral and IV administration of [14C]PF-07220060 microtracer doses in cohort 1 and 2, respectively. The total radioactivity excreted in urine following oral and IV administration, expressed as percentage of radioactive dose administered is reported in the descriptive section and fraction of dose absorbed is reported in the statistical analysis section.
Measured: From Predose up to 14 days post-dose
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
An adverse event (AE) was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. TEAEs were defined as any AEs that occurred following start of study intervention and during follow-up within the lag time of up to 35 days after the last dose of study intervention.
Measured: Baseline up to 35 days after the last dose of study intervention (up to Day 36)
Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters
Following laboratory parameters were analyzed: clinical chemistry: alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, bicarbonates, total bilirubin, calcium, chloride, creatinine, cystatin C, estimated glomerular filtration rate (eGFR) serum creatinine, glucose, potassium, protein, sodium, uric acid, blood urea nitrogen. Hematology included basophils, eosinophils, erythrocytes, hematocrit, hemoglobin, leukocytes, lymphocytes, monocytes, neutrophils, platelets and reticulocyte count. Urinalysis included: glucose, blood, ketones, leukocytes esterase, nitrite, protein and pH. Clinical significance of laboratory abnormalities was determined by investigator.
Measured: Baseline up to 35 days after the last dose of study intervention (up to Day 36)
Number of Participants With Clinically Significant Abnormalities in Vital Signs
Vital signs included blood pressure and pulse rate. Blood pressure was measured with the participant in a supine position using an automated device after at least 5 minutes rest for the participant. Clinical significance of vital signs was determined based on investigator's discretion.
Measured: Baseline up to 35 days after the last dose of study intervention (up to Day 36)
Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities
Standard 12-lead ECGs were performed after the participant had rested quietly for at least 5 minutes in a supine position using an ECG machine that automatically calculated the heart rate and measured PR, QT and, corrected QT interval using Fridericia's formula (QTcF) and QRS interval. Clinical significance of ECG abnormalities was determined based on investigator's discretion.
Measured: Baseline up to 35 days after the last dose of study intervention (up to Day 36)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2024
- Study start31 Jan 2024
- Primary completion12 Apr 2024
- Study completion12 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 12 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
- NCT06267963
- Sponsor's protocol ID
- C4391010
- Other IDs
- 2023-507074-40-00, 2023
- Status last verified
- Feb 2026
- First submitted
- 17 Jan 2024
- Last updated
- 10 Mar 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- 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 10 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A PHASE 1, OPEN-LABEL, PARALLEL-GROUP, SINGLE-DOSE STUDY IN HEALTHY ADULT MALE PARTICIPANTS TO INVESTIGATE THE ABSORPTION, DISTRIBUTION, METABOLISM AND EXCRETION OF [14C]-PF-07220060 AND TO ASSESS THE ABSOLUTE BIOAVAILABILITY AND FRACTION ABSORBED OF PF-07220060 USING A 14C-MICROTRACER APPROACH
- ClinicalTrials.gov ID
- NCT06267963
- Acronym / sponsor ID
- C4391010
- 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
- 12 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 31 Jan 2024 (actual)
- Primary completion
- 12 Apr 2024 (actual)
- Study completion
- 12 Apr 2024 (actual)
- First posted
- 20 Feb 2024 (actual)
- Results
- Posted 10 Mar 2026
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 PF-07220060 will be taken up and processed by healthy male participants.
The study is seeking for participants who:
- are males aged 18 to 65 years and are healthy.
- have Body mass index (BMI) between 17.5 and 30.5 kilograms/meter2
- have a total body weight of at least 50 kilograms.
The study consists of two groups. In group 1, participants will take one amount of PF-07220060 by mouth. In group 2, participants will take one amount by mouth and one amount as an injection through a vein at the study clinic.
In group 1, participants will stay at the clinic site for up to 15 days. In group 2, the duration of participants' stay depends on the results of group 1.
During their stays, participants will have their blood, urine, and feces collected by the study doctors several times. We will measure the level of PF-07220060 in participants' blood, urine, and feces samples. This will help to know how much the study medicine is getting taken up by the body. At the end of the study, participants will be contacted by phone to check in. Participants will be involved in this study for about 9 weeks from the screening until the follow-up.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: Oral [14C]PF-07220060Participants will receive one dose of [14C] PF-07220060 by mouth |
| Cohort 2 | Experimental | Drug: Oral PF-07220060, Drug: IV [14C] PF-07220060Participants will take one dose of PF-07220060 by mouth and one dose as an IV (intravenous) infusion of [14C] PF-07220060. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male participants aged 18 to 65 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 17.5-30.5 kg/m2; and a total body weight >50 kg (110 lb).
- Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.
Key exclusion criteria (3 listed)
- Participants with a history of irregular bowel movements (eg, regular episodes of diarrhea or constipation, irritable bowel syndrome [IBS] or lactose intolerance).
- Previous administration with an investigational product (drug or vaccine) within 30 days (or as determined by the local requirement) or 5 half-lives (whichever is longer) preceding the first dose of study intervention used in this study. Previous exposure to PF-07220060 or participation in studies requiring PF-07220060 administration.
- Total 14C radioactivity measured in plasma 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-07220060A single oral dose of [14C]PF-07220060, will be administered as a liquid formulation in Cohort 1. | Drug | Cohort 1 |
| Oral PF-07220060A single oral dose of PF-07220060, will be administered as a liquid formulation in Cohort 2. | Drug | Cohort 2 |
| IV [14C] PF-07220060A single IV infusion of [14C]PF-07220060 will be administered in Cohort 2 at Tmax after the administration of the unlabeled oral dose. | Drug | Cohort 2 |
Primary outcome
Percentage of Total Radiocarbon (14C) Excreted in Urine
Time frame: From Predose up to 14 days post-dose
Percentage of 14C excreted in urine following 14C PF-07220060 dose administration was determined as: (total 14C urine/ 14C dose administered)*100 where, 14C dose was administered dose of 14C PF-07220060.
Percentage of Total Radiocarbon (14C) Excreted in Feces: Cohort 1
Time frame: From Predose up to 14 days post-dose
Percentage of 14C excreted in feces following 14C PF-07220060 oral dose administration was determined as: (total 14C feces/ 14C oral dose administered)*100 where, 14C dose was administered dose of 14C PF-07220060.
Cumulative Percent Recovery of Total Radiocarbon (14C)
Time frame: From Predose up to 14 days post-dose
Percentage recovery of total radioactivity (14C ) in urine and feces was determined based on total administered dose.
Percentage of Metabolite Detected in Plasma After Oral Administration of PF-07220060: Cohort 1
Time frame: From Predose up to 96 hours post-dose
The percentage of five major metabolites detected in plasma after oral administration of PF-07220060: 480a, 480b, 496a, M3 and 496b are reported in this outcome measure. The processed samples were analyzed by liquid chromatography mass spectrometry- accelerator mass spectrometry (LC-MS-AMS). For calculation of metabolite percentage of total plasma radioactivity (RA), first composite time-normalized human plasma pools were prepared for each participant from plasma samples collected from 0-96 hours post-dose (i.e., a hamilton pool). Next, a multi-subject pool was created by combining equal volumes of each of the above individual participant pools. Results presented here are the single value output from these individual pooled multi-subject time-normalized samples.
Percentage of Metabolite Detected in Urine After Oral Administration of PF-07220060: Cohort 1
Time frame: From Predose up to 144 hours post-dose
The percentage of five major metabolites detected in urine after oral administration of PF-07220060: 480a, 480b, 496a, M3 and 496b are reported in this outcome measure. The processed samples were analyzed by LC-MS-AMS. For calculation of percentage of metabolites, first composite time-normalized human urine pools were prepared for each participant from urine samples collected from 0-144 hours post-dose (i.e., a hamilton pool). Next, a multi-subject pool was created by combining equal volumes of each of the above individual participant pools. Results presented here are the single value output from these individual pooled multi-subject time-normalized samples.
Percentage of Metabolite Detected in Feces After Oral Administration of PF-07220060: Cohort 1
Time frame: From Predose up to 196 hours post-dose
The percentage of five major metabolites detected in feces after oral administration of PF-07220060: 480a, 480b, 496a, M3 and 496b are reported in this outcome measure. The processed samples were analyzed by LC-MS-AMS. For calculation of percentage of metabolites, first composite time-normalized human fecal homogenate pools were prepared for each participant from fecal samples collected from 0-196 hours post-dose (i.e., a hamilton pool). Next, a multi-subject pool was created by combining equal volumes of each of the above individual participant pools. Results presented here are the single value output from these individual pooled multi-subject time-normalized samples.
Percentage of Metabolite Detected in Feces After IV Administration of PF-07220060: Cohort 2
Time frame: From Predose up to 196 hours post-dose
The percentage of five major metabolites detected in feces after IV administration of PF-07220060: 480a, 480b, 496a, M3 and 496b are reported in this outcome measure. The processed samples were analyzed by LC-MS-AMS. For calculation of percentage of metabolites, first composite time-normalized human fecal homogenate pools were prepared for each participant from fecal samples collected from 0-196 hours post-dose (i.e., a hamilton pool). Next, a multi-subject pool was created by combining equal volumes of each of the above individual participant pools. Results presented here are the single value output from these individual pooled multi-subject time-normalized samples.
6 secondary outcomes
Absolute Oral Bioavailability for Plasma Dose-Normalized Area Under the Curve (AUC)Infinity: Cohort 2
Time frame: From Predose up to 14 days post-dose
Cohort 1 and 2: Fraction of PF-07220060 Dose Absorbed (Fa)
Time frame: From Predose up to 14 days post-dose
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Time frame: Baseline up to 35 days after the last dose of study intervention (up to Day 36)
Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters
Time frame: Baseline up to 35 days after the last dose of study intervention (up to Day 36)
Number of Participants With Clinically Significant Abnormalities in Vital Signs
Time frame: Baseline up to 35 days after the last dose of study intervention (up to Day 36)
Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities
Time frame: Baseline up to 35 days after the last dose of study intervention (up to Day 36)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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-07220060, Oral PF-07220060 and IV [14C] PF-07220060 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 3 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 Mar 2026. 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?
Yes. Results are posted in the registry (first posted 10 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percentage of Total Radiocarbon (14C) Excreted in Urine (time frame: From Predose up to 14 days post-dose). The study lists 7 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 10 Mar 2026.