HealthyPhase 1NCT06777602
A Clinical Study To Understand How Radiolabeled MK-5475 Is Taken Up By The Body, Broken Down And Then Removed From The Body in Healthy Participants (MK-5475-011)
A Phase 1 study testing [14C] MK-5475 in people with Healthy, run by Merck Sharp & Dohme LLC at 1 site in United States.
Trial summary
The goal of this study is to understand how radiolabeled MK-5475 administered intravenously (IV) is taken up by the body, broken down and then removed from the body in healthy male participants. The study also aims to understand how much of the compound is broken down and how much leaves the body unchanged. Read more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- [14C] MK-5475
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Aug 2022to 25 Oct 2022
- 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 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Is in good health.
- Body mass index (BMI) >18 and ≤32 kg/m2, inclusive.
Who cannot join
- Has history of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases.
- Has significant multiple and/or severe allergies, or has had an anaphylactic reaction or significant intolerability to prescription or nonprescription drugs or food.
- Has had a major surgery and/or donated or lost 1 unit of blood (approximately 500 mL) or blood products within 4 weeks prior to the prestudy (screening).
- Has history of exposure to significant diagnostic or therapeutic radiation or current employment in a job requiring radiation exposure monitoring within 12 months prior to check-in.
- Has participated in more than 3 radiolabeled drug studies in the last 12 months.
Trial locations and contacts
1 site in 1 country.
United States1 site
Labcorp Clinical Research Unit Inc. (Site 0001)
Madison, Wisconsin, 53704
About this study
Official title: An Open-label Phase 1 IV Study to Evaluate Metabolism, Excretion, and Mass Balance of [14C]MK-5475 in Healthy Participants
The goal of this study is to understand how radiolabeled MK-5475 administered intravenously (IV) is taken up by the body, broken down and then removed from the body in healthy male participants. The study also aims to understand how much of the compound is broken down and how much leaves the body unchanged.
- Conditions
- Healthy
- Being tested
- [14C] MK-5475
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[14C] MK-5475Drug
[14C] MK-5475 is administered as a single IV bolus dose in healthy male participants on Day 1.
| Study group | Role | What they receive |
|---|---|---|
| [14C] MK-5475 | Experimental | [14C] MK-5475 is administered as single IV bolus dose of 100μg on Day 1. Receives: Drug: [14C] MK-5475 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amount Excreted in Urine (Aeu)
Amount of [14C]MK-5475 and its metabolites excreted in urine (Aeu) derived from urine collections at each sampling interval.
Measured: At designated time points (Up to ~ 23 days)
Cumulative Aeu
Cumulative amount of [14C] MK-5475 and its metabolites excreted in urine derived from urine collections at each sampling interval
Measured: At designated time points (Up to ~ 23 days)
Percentage Excreted in Urine (feu)
Percentage of [14C]MK-5475 and its metabolites excreted in urine derived from urine collections at each sampling interval.
Measured: At designated time points (Up to ~ 23 days)
Cumulative feu
Cumulative percentage of [14C]MK-5475 and its metabolites excreted in urine derived from urine collections at each sampling interval.
Measured: At designated time points (Up to ~ 23 days)
Amount Excreted in Feces (Aef)
Amount of [14C]MK-5475 and its metabolites excreted in feces derived from feces collections at each sampling interval.
Measured: At designated time points (Up to ~ 23 days)
Cumulative Aef
Cumulative amount of [14C]MK-5475 and its metabolites excreted in feces derived from feces collections at each sampling interval.
Measured: At designated time points (Up to ~ 23 days)
Cumulative Fef
Cumulative percentage of [14C]MK-5475 and its metabolites excreted in feces derived from feces collections at each sampling interval.
Measured: At designated time points (Up to ~ 23 days)
AUC0-t
Area under concentration time curve (AUC) from time zero to the last quantifiable concentration derived from the whole blood and plasma concentration-time profiles following IV administration of [14C]MK-5475.
Measured: At designated time points (Up to ~ 23 days)
AUC0-infinity
AUC from time zero extrapolated to infinity derived from the whole blood and plasma concentration-time profiles following IV administration of [14C]MK-5475.
Measured: At designated time points (Up to ~ 23 days)
Maximum Plasma Concentration (Cmax)
Cmax is the measure of the maximum amount of [14C]MK-5475 in the plasma after the dose is given.
Measured: At designated time points (Up to ~ 23 days)
Half-life t1/2
T1/2 is the time required for [14C]MK-5475 concentration in the plasma to decrease by 50%.
Measured: At designated time points (Up to ~ 23 days)
Time to Maximum Plasma Concentration (Tmax),
Tmax is a measure of the time to reach the maximum concentration in the plasma after the [14C]MK-5475 dose.
Measured: At designated time points (Up to ~ 23 days)
Apparent Total Clearance (CL; MK-5475 only)
CL is defined as apparent total clearance of [14C]MK-5475 from plasma after IV administration
Measured: At designated time points (Up to ~ 23 days)
Apparent Volume of Distribution (Vz; MK-5475 only)
Vz is defined as apparent volume of distribution of [14C]MK-5475 during terminal phase after IV administration.
Measured: At designated time points (Up to ~ 23 days)
AUC0-infinity Plasma [14C]MK-5475/Total Radioactivity Ratio
AUC time zero to infinity (0-∞) of [14C]MK-5475 in plasma/AUC0-∞ of total radioactivity in plasma.
Measured: At designated time points (Up to ~ 23 days)
Secondary outcomes (2)
Number of Participants Who Experience an Adverse Event (AE)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who experience an AE will be reported.
Measured: Up to ~ 30 days
Number of Participants Who Discontinue Study Due to an AE
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who discontinue study due to an AE will be reported.
Measured: Up to ~ 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2025
- Study start15 Aug 2022
- Primary completion30 Sep 2022
- Study completion25 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe 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
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06777602
- Sponsor's protocol ID
- 5475-011
- Other IDs
- MK-5475-011
- Status last verified
- Oct 2025
- First submitted
- 10 Jan 2025
- Last updated
- 29 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
Publications
Menzel K, Liang Y, Chen B, Li D, Cislak D, Bajwa EK. An Intravenous Study with the Radiolabeled sGC Stimulator Frespaciguat to Assess PK, Metabolism, and Mass Balance. J Clin Pharmacol. 2025 Nov;65(11):1561-1567. doi: 10.1002/jcph.70066. Epub 2025 Jun 19.
PubMed 40534306
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label Phase 1 IV Study to Evaluate Metabolism, Excretion, and Mass Balance of [14C]MK-5475 in Healthy Participants
- ClinicalTrials.gov ID
- NCT06777602
- Acronym / sponsor ID
- 5475-011
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- 15 Aug 2022 (actual)
- Primary completion
- 30 Sep 2022 (actual)
- Study completion
- 25 Oct 2022 (actual)
- First posted
- 16 Jan 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 goal of this study is to understand how radiolabeled MK-5475 administered intravenously (IV) is taken up by the body, broken down and then removed from the body in healthy male participants. The study also aims to understand how much of the compound is broken down and how much leaves the body unchanged.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| [14C] MK-5475 | Experimental | Drug: [14C] MK-5475[14C] MK-5475 is administered as single IV bolus dose of 100μg on Day 1. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Is in good health.
- Body mass index (BMI) >18 and ≤32 kg/m2, inclusive.
Key exclusion criteria (5 listed)
- Has history of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases.
- Has significant multiple and/or severe allergies, or has had an anaphylactic reaction or significant intolerability to prescription or nonprescription drugs or food.
- Has had a major surgery and/or donated or lost 1 unit of blood (approximately 500 mL) or blood products within 4 weeks prior to the prestudy (screening).
- Has history of exposure to significant diagnostic or therapeutic radiation or current employment in a job requiring radiation exposure monitoring within 12 months prior to check-in.
- Has participated in more than 3 radiolabeled drug studies in the last 12 months.
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] MK-5475[14C] MK-5475 is administered as a single IV bolus dose in healthy male participants on Day 1. | Drug | [14C] MK-5475 |
Primary outcome
Amount Excreted in Urine (Aeu)
Time frame: At designated time points (Up to ~ 23 days)
Amount of [14C]MK-5475 and its metabolites excreted in urine (Aeu) derived from urine collections at each sampling interval.
Cumulative Aeu
Time frame: At designated time points (Up to ~ 23 days)
Cumulative amount of [14C] MK-5475 and its metabolites excreted in urine derived from urine collections at each sampling interval
Percentage Excreted in Urine (feu)
Time frame: At designated time points (Up to ~ 23 days)
Percentage of [14C]MK-5475 and its metabolites excreted in urine derived from urine collections at each sampling interval.
Cumulative feu
Time frame: At designated time points (Up to ~ 23 days)
Cumulative percentage of [14C]MK-5475 and its metabolites excreted in urine derived from urine collections at each sampling interval.
Amount Excreted in Feces (Aef)
Time frame: At designated time points (Up to ~ 23 days)
Amount of [14C]MK-5475 and its metabolites excreted in feces derived from feces collections at each sampling interval.
Cumulative Aef
Time frame: At designated time points (Up to ~ 23 days)
Cumulative amount of [14C]MK-5475 and its metabolites excreted in feces derived from feces collections at each sampling interval.
Cumulative Fef
Time frame: At designated time points (Up to ~ 23 days)
Cumulative percentage of [14C]MK-5475 and its metabolites excreted in feces derived from feces collections at each sampling interval.
AUC0-t
Time frame: At designated time points (Up to ~ 23 days)
Area under concentration time curve (AUC) from time zero to the last quantifiable concentration derived from the whole blood and plasma concentration-time profiles following IV administration of [14C]MK-5475.
AUC0-infinity
Time frame: At designated time points (Up to ~ 23 days)
AUC from time zero extrapolated to infinity derived from the whole blood and plasma concentration-time profiles following IV administration of [14C]MK-5475.
Maximum Plasma Concentration (Cmax)
Time frame: At designated time points (Up to ~ 23 days)
Cmax is the measure of the maximum amount of [14C]MK-5475 in the plasma after the dose is given.
Half-life t1/2
Time frame: At designated time points (Up to ~ 23 days)
T1/2 is the time required for [14C]MK-5475 concentration in the plasma to decrease by 50%.
Time to Maximum Plasma Concentration (Tmax),
Time frame: At designated time points (Up to ~ 23 days)
Tmax is a measure of the time to reach the maximum concentration in the plasma after the [14C]MK-5475 dose.
Apparent Total Clearance (CL; MK-5475 only)
Time frame: At designated time points (Up to ~ 23 days)
CL is defined as apparent total clearance of [14C]MK-5475 from plasma after IV administration
Apparent Volume of Distribution (Vz; MK-5475 only)
Time frame: At designated time points (Up to ~ 23 days)
Vz is defined as apparent volume of distribution of [14C]MK-5475 during terminal phase after IV administration.
AUC0-infinity Plasma [14C]MK-5475/Total Radioactivity Ratio
Time frame: At designated time points (Up to ~ 23 days)
AUC time zero to infinity (0-∞) of [14C]MK-5475 in plasma/AUC0-∞ of total radioactivity in plasma.
2 secondary outcomes
Number of Participants Who Experience an Adverse Event (AE)
Time frame: Up to ~ 30 days
Number of Participants Who Discontinue Study Due to an AE
Time frame: Up to ~ 30 days
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 29 Oct 2025.
- Results publication: PubMed 40534306Menzel K, Liang Y, Chen B, Li D, Cislak D, Bajwa EK. An Intravenous Study with the Radiolabeled sGC Stimulator Frespaciguat to Assess PK, Metabolism, and Mass Balance. J Clin Pharmacol. 2025 Nov;65(11):1561-1567. doi: 10.1002/jcph.70066. Epub 2025 Jun 19.
- Merck Clinical Trials InformationLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
Related trials for Healthy
Not yet recruitingPhase 1
Dynamic Magnetic Resonance Imaging of Human Subarachnoid Space Using Intrathecal Gadolinium Contrast
Healthy Volunteers
RecruitingObservational study
Survey to Determine Incarcerated Persons' Views on Surrogate Decision Making
Healthy Volunteers
Active, not recruitingPhase 1
A Study to Learn How Different Amounts of the Study Medicine Called PF-07985631 Are Tolerated and Act in the Body of Healthy Adults
Healthy
Not yet recruitingObservational study
Collection and Distribution of Blood Components From Healthy Donors for In Vitro Research Use
Blood Donors, Apheresis
Recruiting
Metabolic Impact of VLCPUFA-Rich Fish Oil: A Clinical Study on Omega-3 Index Enhancement in Healthy Individuals
Fatty Acids, Omega-3, Fish Oils
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 Director study director
Merck Sharp & Dohme LLC
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] MK-5475 in people with Healthy, run by Merck Sharp & Dohme LLC at 1 site in United States.
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 2 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 29 Oct 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 United States. 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?
Amount Excreted in Urine (Aeu) (time frame: At designated time points (Up to ~ 23 days)). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06777602, which also lists 1 linked publication.
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 29 Oct 2025.