Solid TumorPhase 1NCT06308263
Tuvusertib (M1774) Human Mass Balance and Absolute Bioavailability Study (DDRIVER Solid Tumors 303)
A Phase 1 study testing Tuvusertib [14C]Tuvusertib microtracer, Tuvusertib and Tuvusertib + [14C]Tuvusertib microdose bolus injection in people with Solid Tumor, run by Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany at 1 site in Hungary.
Trial summary
This is a single sequence 2-period open label study in participants with advanced solid tumors. The purpose of Period 1 of this study is to assess the mass balance to determine drug-related entities present in circulation and excreta and provide a comprehensive understanding of biotransformation pathways and clearance… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor
- What is being tested?
- Tuvusertib [14C]Tuvusertib microtracer, Tuvusertib and Tuvusertib + [14C]Tuvusertib microdose bolus injection
- 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 siteHungary
- Study dates
- 25 Mar 2024to 14 Apr 2026
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Are histologically proven advanced solid tumors that are considered appropriate for treatment in Period 2 of this study, for which no effective standard therapy exists, or standard therapy has failed or cannot be tolerated
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) less than or equal to 1 (<=) 1
- Have evaluable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 at Screening
- Are capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and this protocol
- Other protocol defined inclusion criteria could apply
Who cannot join
- Uncontrolled or poorly controlled arterial hypertension, symptomatic congestive heart failure (New York Heart Association Classification more than equal to (>=) Class III), uncontrolled cardiac arrhythmia, calculated Corrected QT interval (QTc) average using the QT Interval Corrected Using Fridericia's Formula (QTcF) more than (>) 480 msec; unstable angina pectoris, myocardial infarction, or a coronary revascularization procedure, cerebral vascular accident, transient ischemic attack, or any other significant vascular disease within 180 days of study intervention start
- Presence of toxicities due to prior anticancer therapies (e.g. radiotherapy, chemotherapy, immunotherapies, Et cetera (etc.)) that do not recover to (<=) Grade 1 with the exception of toxicities that do not pose a safety risk to the participant in the judgment of the Investigator (e.g. ongoing Grade 2 alopecia)
- Treatment with live or live attenuated vaccine within 30 days of dosing (non-replicating vector vaccines are permitted)
- Participation in a study involving administration of 14C-labeled compound(s) within last 6 months prior to start of study intervention
- Other protocol defined exclusion criteria could apply
Trial locations and contacts
1 site in 1 country.
Hungary1 site
Pharmaceutical Research Associates Magyarország Kutatás - Fejlesztési Kft., Klinikai Farmakológiai Vizsgálóhely
Budapest
About this study
Official title: Phase 1 Study to Evaluate the Mass Balance, Pharmacokinetics, Metabolism, Excretion and Absolute Bioavailability of Tuvusertib (M1774) Containing Microtracer 14C Tuvusertib in Participants With Advanced Solid Tumors (DDRIVER Solid Tumors 303)
This is a single sequence 2-period open label study in participants with advanced solid tumors. The purpose of Period 1 of this study is to assess the mass balance to determine drug-related entities present in circulation and excreta and provide a comprehensive understanding of biotransformation pathways and clearance mechanisms in participants with advanced solid tumors. The purpose of Period 1a is to assess the extent of ABA of tuvusertib and the mass balance, PK, metabolism, and elimination of 14C-tuvusertib after iv dosing in participants with advanced solid tumors. After either Period 1 or Period 1a; participants may enter an optional extension phase (Period 2) where participants will receive tuvusertib until disease progression or other criteria for study intervention discontinuation are met.
- Conditions
- Solid Tumor
- Being tested
- Tuvusertib [14C]Tuvusertib microtracer, Tuvusertib, Tuvusertib + [14C]Tuvusertib microdose bolus injection
- Keywords
- Ataxia telangiectasia mutated and Rad3-related (ATR) inhibitor, ADME, Tuvusertib (M1774)
- Medical subject headings
- Hereditary Sensory and Autonomic Neuropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tuvusertib [14C]Tuvusertib microtracerDrug
Also called M1774
Participants will receive single oral dose of Tuvusertib containing a [14C] Tuvusertib microtracer solution on Day 1 of period 1 under fasted conditions.
TuvusertibDrug
Also called M1774
Participants will also receive a single oral dose of Tuvusertib on Day 1 of Period 1 or Period 1a, and daily single oral dose of Tuvusertib for 2 weeks in 21 days cycle of Period 2.
Tuvusertib + [14C]Tuvusertib microdose bolus injectionDrug
Also called M1774
In Period 1a, participants will receive on Day 1 of Period 1 a single oral dose of tuvusertib and an intravenous (IV) (14C) tuvusertib microdose as bolus injection.
| Study group | Role | What they receive |
|---|---|---|
| Period 1: Mass Balance: Tuvusertib + [14C]Tuvusertib microtracer | Experimental | Not described Receives: Drug: Tuvusertib [14C]Tuvusertib microtracer; Drug: Tuvusertib |
| Period 1a: Absolute Bioavailability: Tuvusertib + [14C]Tuvusertib microdose bolus injection | Experimental | Not described Receives: Drug: Tuvusertib; Drug: Tuvusertib + [14C]Tuvusertib microdose bolus injection |
| Period 2: Tuvusertib | Experimental | Not described Receives: Drug: Tuvusertib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Period 1: Percent Urinary Recovery (feurine) Of Total Radioactivity (TRA) Over the Entire Period Of Collection
Measured: Pre-dose up to 312-336 hours post dose
Period 1: Percent Fecal Recovery (fefeces) Of TRA Over the Entire Period Of Collection
Measured: Pre-dose up to 312-336 hours post-dose
Period 1: Percent Total Recovery in Urine and Feces (fetotal) Of TRA Over the Entire Period of Collection
Measured: Pre-dose up to 312-336 hours post-dose
Period 1 and 1a: Maximum Observed Plasma Concentration (Cmax) Of Tuvusertib
Measured: Pre-dose up to 336 hours post-dose
Period 1 and 1a: Time to Reach Maximum Plasma Concentration (Tmax) Of Tuvusertib
Measured: Pre-dose up to 336 hours post-dose
Period 1 and 1a: Area Under the Plasma Concentration-Time Curve from Time Zero to the Time of the Last Quantifiable Concentration (AUC0-tlast) Of Tuvusertib
Measured: Pre-dose up to 336 hours post-dose
Period 1 and 1a: Area Under the Plasma Concentration-Time Curve (AUC) from Time Zero Extrapolated to Infinity (AUC0-inf) Of Tuvusertib
Measured: Pre-dose up to 336 hours post-dose
Period 1 and 1a: Apparent Terminal Half-Life (t1/2) Of Tuvusertib
Measured: Pre-dose up to 336 hours post-dose
Period 1 and 1a: Apparent Total Body Clearance (CL/F) Of Tuvusertib
Measured: Pre-dose up to 336 hours post-dose
Period 1 and 1a: Apparent Volume of Distribution (Vz/F) Of Tuvusertib
Measured: Pre-dose up to 336 hours post-dose
Period 1: Maximum Observed Concentration (Cmax) of TRA in Plasma and Whole Blood
Measured: Pre-dose up to 336 hours post-dose
Period 1: Time to Reach Maximum Concentration (tmax) of TRA in Plasma and Whole blood
Measured: Pre-dose up to 336 hours post-dose
Period 1: Area Under Concentration-Time Curve from Time Zero to the Time of the Last Quantifiable Concentration (AUC0-tlast) of TRA in Plasma and Whole Blood
Measured: Pre-dose up to 336 hours post-dose
Period 1: Area Under the Concentration-Time Curve from Time Zero Extrapolated to Infinity (AUC0-inf) of TRA in Plasma and Whole Blood
Measured: Pre-dose up to 336 hours post-dose
Period 1: Apparent Terminal Half-Life (t1/2) of TRA in Plasma and Whole Blood
Measured: Pre-dose up to 336 hours post-dose
Period 1a: Ratio of Dose Normalized AUC0-infinity of Tuvusertib and 14C Tuvusertib in Plasma
Measured: Pre-dose up to 336 hours post-dose
Period 1a: Initial Concentration (C0) at Time Zero After Bolus Intervention Administration of 14[C] Tuvusertib
Measured: Pre-dose up to 336 hours post-dose
Period 1a: Maximum Observed Concentration (Cmax) at Intravenous Administration of 14 [C] Tuvusertib
Measured: Pre-dose up to 336 hours post-dose
Period 1a: Total Body Clearance (CL) Following at Intravenous Administration of 14[C] Tuvusertib
Measured: Pre-dose up to 336 hours post-dose
Period 1a: Volume of Distribution (Vz) during the terminal phase following intravenous administration of 14[C] Tuvusertib
Measured: Pre-dose upto 336 hours post-dose
Period 1a: Volume of Distribution at Steady State (Vss) Following at Intravenous Administration of 14[C] Tuvusertib
Measured: Pre-dose up to 336 hours post-dose
Period 1a: Area Under the Plasma Concentration-Time Curve from Time Zero to the Time of the Last Quantifiable Concentration (AUC0-tlast) at Intravenous Administration of 14[C] Tuvusertib
Measured: Pre-dose up to 336 hours post-dose
Period 1a: Area Under the Plasma Concentration-Time Curve (AUC) from Time Zero Extrapolated to Infinity (AUC0-inf) at Intravenous Administration of 14[C] Tuvusertib
Measured: Pre-dose up to 336 hours post-dose
Period 1a: Apparent Terminal Half-Life (t1/2) at Intravenous Administration of 14[C] Tuvusertib
Measured: Pre-dose up to 336 hours post-dose
Secondary outcomes (1)
Period 1,1a,2: Number of Participants with Treatment-Emergent Adverse Events (TEAEs), Treatment-Related AEs, Abnormal Laboratory Parameters, abnormal Vital Signs and abnormal 12-Lead Electrocardiogram (ECG) Findings
Measured: Baseline up to safety follow up (assessed up to approximately 21 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2024
- Study start25 Mar 2024
- Primary completion14 Apr 2026
- Study completion14 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Responsible, Study director, Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06308263
- Sponsor's protocol ID
- MS201924_0003
- Other IDs
- 2022-502940-10-00
- Status last verified
- Apr 2026
- First submitted
- 6 Mar 2024
- Last updated
- 23 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We are committed to enhancing public health through responsible sharing of clinical trial data. Following approval of a new product or a new indication for an approved product in both the US and European Union, the study sponsor and/or its affiliated companies will share study protocols, anonymized patient data and study level data, and redacted clinical study reports with qualified scientific and medical researchers, upon request, as necessary for conducting legitimate research. Further information on how to request data can be found on our website bit.ly/IPD21.
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Study to Evaluate the Mass Balance, Pharmacokinetics, Metabolism, Excretion and Absolute Bioavailability of Tuvusertib (M1774) Containing Microtracer 14C Tuvusertib in Participants With Advanced Solid Tumors (DDRIVER Solid Tumors 303)
- ClinicalTrials.gov ID
- NCT06308263
- Acronym / sponsor ID
- MS201924_0003
- Conditions
- Solid Tumor
- Keywords
- Ataxia telangiectasia mutated and Rad3-related (ATR) inhibitor, ADME, Tuvusertib (M1774)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, GermanyIndustry (pharma, biotech, devices)
- Study start
- 25 Mar 2024 (actual)
- Primary completion
- 14 Apr 2026 (actual)
- Study completion
- 14 Apr 2026 (actual)
- First posted
- 13 Mar 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.
This is a single sequence 2-period open label study in participants with advanced solid tumors. The purpose of Period 1 of this study is to assess the mass balance to determine drug-related entities present in circulation and excreta and provide a comprehensive understanding of biotransformation pathways and clearance mechanisms in participants with advanced solid tumors. The purpose of Period 1a is to assess the extent of ABA of tuvusertib and the mass balance, PK, metabolism, and elimination of 14C-tuvusertib after iv dosing in participants with advanced solid tumors. After either Period 1 or Period 1a; participants may enter an optional extension phase (Period 2) where participants will receive tuvusertib until disease progression or other criteria for study intervention discontinuation are met.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Period 1: Mass Balance: Tuvusertib + [14C]Tuvusertib microtracer | Experimental | Drug: Tuvusertib [14C]Tuvusertib microtracer, Drug: Tuvusertib |
| Period 1a: Absolute Bioavailability: Tuvusertib + [14C]Tuvusertib microdose bolus injection | Experimental | Drug: Tuvusertib, Drug: Tuvusertib + [14C]Tuvusertib microdose bolus injection |
| Period 2: Tuvusertib | Experimental | Drug: Tuvusertib |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Are histologically proven advanced solid tumors that are considered appropriate for treatment in Period 2 of this study, for which no effective standard therapy exists, or standard therapy has failed or cannot be tolerated
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) less than or equal to 1 (<=) 1
- Have evaluable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 at Screening
- Are capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and this protocol
- Other protocol defined inclusion criteria could apply
Key exclusion criteria (5 listed)
- Uncontrolled or poorly controlled arterial hypertension, symptomatic congestive heart failure (New York Heart Association Classification more than equal to (>=) Class III), uncontrolled cardiac arrhythmia, calculated Corrected QT interval (QTc) average using the QT Interval Corrected Using Fridericia's Formula (QTcF) more than (>) 480 msec; unstable angina pectoris, myocardial infarction, or a coronary revascularization procedure, cerebral vascular accident, transient ischemic attack, or any other significant vascular disease within 180 days of study intervention start
- Presence of toxicities due to prior anticancer therapies (e.g. radiotherapy, chemotherapy, immunotherapies, Et cetera (etc.)) that do not recover to (<=) Grade 1 with the exception of toxicities that do not pose a safety risk to the participant in the judgment of the Investigator (e.g. ongoing Grade 2 alopecia)
- Treatment with live or live attenuated vaccine within 30 days of dosing (non-replicating vector vaccines are permitted)
- Participation in a study involving administration of 14C-labeled compound(s) within last 6 months prior to start of study intervention
- Other protocol defined exclusion criteria could apply
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 |
|---|---|---|
| Tuvusertib [14C]Tuvusertib microtracerAlso: M1774Participants will receive single oral dose of Tuvusertib containing a [14C] Tuvusertib microtracer solution on Day 1 of period 1 under fasted conditions. | Drug | Period 1: Mass Balance: Tuvusertib + [14C]Tuvusertib microtracer |
| TuvusertibAlso: M1774Participants will also receive a single oral dose of Tuvusertib on Day 1 of Period 1 or Period 1a, and daily single oral dose of Tuvusertib for 2 weeks in 21 days cycle of Period 2. | Drug | Period 1: Mass Balance: Tuvusertib + [14C]Tuvusertib microtracer, Period 1a: Absolute Bioavailability: Tuvusertib + [14C]Tuvusertib microdose bolus injection, Period 2: Tuvusertib |
| Tuvusertib + [14C]Tuvusertib microdose bolus injectionAlso: M1774In Period 1a, participants will receive on Day 1 of Period 1 a single oral dose of tuvusertib and an intravenous (IV) (14C) tuvusertib microdose as bolus injection. | Drug | Period 1a: Absolute Bioavailability: Tuvusertib + [14C]Tuvusertib microdose bolus injection |
Primary outcome
Period 1: Percent Urinary Recovery (feurine) Of Total Radioactivity (TRA) Over the Entire Period Of Collection
Time frame: Pre-dose up to 312-336 hours post dose
Period 1: Percent Fecal Recovery (fefeces) Of TRA Over the Entire Period Of Collection
Time frame: Pre-dose up to 312-336 hours post-dose
Period 1: Percent Total Recovery in Urine and Feces (fetotal) Of TRA Over the Entire Period of Collection
Time frame: Pre-dose up to 312-336 hours post-dose
Period 1 and 1a: Maximum Observed Plasma Concentration (Cmax) Of Tuvusertib
Time frame: Pre-dose up to 336 hours post-dose
Period 1 and 1a: Time to Reach Maximum Plasma Concentration (Tmax) Of Tuvusertib
Time frame: Pre-dose up to 336 hours post-dose
Period 1 and 1a: Area Under the Plasma Concentration-Time Curve from Time Zero to the Time of the Last Quantifiable Concentration (AUC0-tlast) Of Tuvusertib
Time frame: Pre-dose up to 336 hours post-dose
Period 1 and 1a: Area Under the Plasma Concentration-Time Curve (AUC) from Time Zero Extrapolated to Infinity (AUC0-inf) Of Tuvusertib
Time frame: Pre-dose up to 336 hours post-dose
Period 1 and 1a: Apparent Terminal Half-Life (t1/2) Of Tuvusertib
Time frame: Pre-dose up to 336 hours post-dose
Period 1 and 1a: Apparent Total Body Clearance (CL/F) Of Tuvusertib
Time frame: Pre-dose up to 336 hours post-dose
Period 1 and 1a: Apparent Volume of Distribution (Vz/F) Of Tuvusertib
Time frame: Pre-dose up to 336 hours post-dose
Period 1: Maximum Observed Concentration (Cmax) of TRA in Plasma and Whole Blood
Time frame: Pre-dose up to 336 hours post-dose
Period 1: Time to Reach Maximum Concentration (tmax) of TRA in Plasma and Whole blood
Time frame: Pre-dose up to 336 hours post-dose
Period 1: Area Under Concentration-Time Curve from Time Zero to the Time of the Last Quantifiable Concentration (AUC0-tlast) of TRA in Plasma and Whole Blood
Time frame: Pre-dose up to 336 hours post-dose
Period 1: Area Under the Concentration-Time Curve from Time Zero Extrapolated to Infinity (AUC0-inf) of TRA in Plasma and Whole Blood
Time frame: Pre-dose up to 336 hours post-dose
Period 1: Apparent Terminal Half-Life (t1/2) of TRA in Plasma and Whole Blood
Time frame: Pre-dose up to 336 hours post-dose
Period 1a: Ratio of Dose Normalized AUC0-infinity of Tuvusertib and 14C Tuvusertib in Plasma
Time frame: Pre-dose up to 336 hours post-dose
Period 1a: Initial Concentration (C0) at Time Zero After Bolus Intervention Administration of 14[C] Tuvusertib
Time frame: Pre-dose up to 336 hours post-dose
Period 1a: Maximum Observed Concentration (Cmax) at Intravenous Administration of 14 [C] Tuvusertib
Time frame: Pre-dose up to 336 hours post-dose
Period 1a: Total Body Clearance (CL) Following at Intravenous Administration of 14[C] Tuvusertib
Time frame: Pre-dose up to 336 hours post-dose
Period 1a: Volume of Distribution (Vz) during the terminal phase following intravenous administration of 14[C] Tuvusertib
Time frame: Pre-dose upto 336 hours post-dose
Period 1a: Volume of Distribution at Steady State (Vss) Following at Intravenous Administration of 14[C] Tuvusertib
Time frame: Pre-dose up to 336 hours post-dose
Period 1a: Area Under the Plasma Concentration-Time Curve from Time Zero to the Time of the Last Quantifiable Concentration (AUC0-tlast) at Intravenous Administration of 14[C] Tuvusertib
Time frame: Pre-dose up to 336 hours post-dose
Period 1a: Area Under the Plasma Concentration-Time Curve (AUC) from Time Zero Extrapolated to Infinity (AUC0-inf) at Intravenous Administration of 14[C] Tuvusertib
Time frame: Pre-dose up to 336 hours post-dose
Period 1a: Apparent Terminal Half-Life (t1/2) at Intravenous Administration of 14[C] Tuvusertib
Time frame: Pre-dose up to 336 hours post-dose
1 secondary outcome
Period 1,1a,2: Number of Participants with Treatment-Emergent Adverse Events (TEAEs), Treatment-Related AEs, Abnormal Laboratory Parameters, abnormal Vital Signs and abnormal 12-Lead Electrocardiogram (ECG) Findings
Time frame: Baseline up to safety follow up (assessed up to approximately 21 months)
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 Apr 2026.
- Trial Awareness and Transparency websiteLink provided by the sponsor.
- US Medical Information website, Medical ResourcesLink provided by the sponsor.
- Individual participant dataSharing planned: No. We are committed to enhancing public health through responsible sharing of clinical trial data. Following approval of a new product or a new indication for an approved product in both the US and European Union, the study sponsor and/or its affiliated companies will share study protocols, anonymized patient data and study level data, and redacted clinical study reports with qualified scientific and medical researchers, upon request, as necessary for conducting legitimate research. Further information on how to request data can be found on our website bit.ly/IPD21.
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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.
Medical Responsible study director
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
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 Tuvusertib [14C]Tuvusertib microtracer, Tuvusertib and Tuvusertib + [14C]Tuvusertib microdose bolus injection in people with Solid Tumor, run by Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany at 1 site in Hungary.
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 5 inclusion and 5 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 Apr 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 Hungary. 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?
Period 1: Percent Urinary Recovery (feurine) Of Total Radioactivity (TRA) Over the Entire Period Of Collection (time frame: Pre-dose up to 312-336 hours post dose). The study lists 24 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 Apr 2026; AzTrials last refreshed its copy on 31 Oct 2026.