HealthyPhase 1NCT06826989
A Study of MK-8527 in Healthy Adult Participants (MK-8527-013)
A Phase 1 study testing [14C]MK-8527 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 learn how [14C]MK-8527 moves through a healthy person's body over time. Researchers will study how [14C]MK-8527 is absorbed by the body, broken down by the body, and how it leaves the body. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- [14C]MK-8527
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Mar 2025to 4 Jun 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Is in good health
- Has a body mass index (BMI) of 18 to 32 kg/m^2
Who cannot join
- Has a history of cancer
- Has positive tests for hepatitis B surface antigen, hepatitis C antibodies or human immunodeficiency virus
Trial locations and contacts
1 site in 1 country.
United States1 site
Fortea CRU Madison ( 0001)
Madison, Wisconsin, 53704
About this study
Official title: A Phase 1 Study to Evaluate the Absorption, Metabolism, and Excretion of [14C]MK-8527 in Healthy Adult Participants
The goal of this study is to learn how [14C]MK-8527 moves through a healthy person's body over time. Researchers will study how [14C]MK-8527 is absorbed by the body, broken down by the body, and how it leaves the body.
- Conditions
- Healthy
- Being tested
- [14C]MK-8527
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[14C]MK-8527Drug
Oral Dose
| Study group | Role | What they receive |
|---|---|---|
| [14C]MK-8527 | Experimental | Participants will receive a single oral dose of [14C]MK-8527 on Day 1 Receives: Drug: [14C]MK-8527 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative Percentage of Total Radioactivity Recovered (fe) from Urine and Feces
Urine and fecal samples will be collected to determine the cumulative percentage of radioactivity recovered from both urine and feces.
Measured: At designated timepoints (up to approximately 5 weeks post-dose)
Fe from Urine
Urine samples will be collected to determine the percent of total radioactivity recovered from urine.
Measured: At designated timepoints (up to approximately 5 weeks post-dose)
Fe from Feces
Fecal samples will be collected to determine the percent of total radioactivity recovered from feces.
Measured: At designated timepoints (up to approximately 5 weeks post-dose)
Plasma MK-8527: Area Under the Concentration-Time Curve from Time 0 to 24 Hours Post-dose (AUC0-24)
Plasma samples will be collected to determine the AUC0-24 of MK-8527.
Measured: At designated timepoints (up to 24 hours post-dose)
Plasma MK-8527: Maximum Observed Concentration (Cmax)
Plasma samples will be collected to determine the Cmax of MK-8527.
Measured: At designated timepoints (up to approximately 14 days post-dose)
Plasma MK-8527: Concentration at 24 Hours Post-dose (C24)
Plasma samples will be collected to determine the C24 of MK-8527.
Measured: At designated timepoints (up to 24 hours post-dose)
Plasma MK-8527: Time of the Maximum Observed Concentration (Tmax)
Plasma samples will be collected to determine the Tmax of MK-8527.
Measured: At designated timepoints (up to approximately 14 days post-dose)
Plasma Total Radioactivity: AUC0-24
Plasma samples will be collected to determine the AUC0-24 of total radioactivity.
Measured: At designated timepoints (up to 24 hours post-dose)
Plasma Total Radioactivity: Cmax
Plasma samples will be collected to determine the Cmax of total radioactivity.
Measured: At designated timepoints (up to approximately 5 weeks post-dose)
Plasma Total Radioactivity: C24
Plasma samples will be collected to determine the C24 of total radioactivity.
Measured: At designated timepoints (up to 24 hours post-dose)
Plasma Total Radioactivity: Tmax
Plasma samples will be collected to determine the Tmax of total radioactivity.
Measured: At designated timepoints (up to approximately 5 weeks post-dose)
Whole Blood Total Radioactivity: AUC0-24
Whole blood samples will be collected to determine the AUC0-24 of total radioactivity.
Measured: At designated timepoints (up to 24 hours post-dose)
Whole Blood Total Radioactivity: Cmax
Whole blood samples will be collected to determine the Cmax of total radioactivity.
Measured: At designated timepoints (up to approximately 5 weeks post-dose)
Whole Blood Total Radioactivity: C24
Whole blood samples will be collected to determine the C24 of total radioactivity.
Measured: At designated timepoints (up to 24 hours post-dose)
Whole blood Total Radioactivity: Tmax
Whole blood samples will be collected to determine the Tmax of total radioactivity.
Measured: At designated timepoints (up to approximately 5 weeks post-dose)
Cumulative Amount of Radioactivity Recovered from Urine
Urine samples will be collected to determine the cumulative amount of radioactivity recovered from urine.
Measured: At designated timepoints (up to approximately 5 weeks post-dose)
Percent of Total Radioactive Dose Recovered from Urine
Urine samples will be collected to determine the percent of the total radioactive dose recovered from urine.
Measured: At designated timepoints (up to approximately 5 weeks post-dose)
Cumulative Amount of Radioactivity Recovered from Feces
Fecal samples will be collected to determine the cumulative amount of radioactivity recovered from feces.
Measured: At designated timepoints (up to approximately 5 weeks post-dose)
Percent of Total Radioactive Dose Recovered from Feces
Fecal samples will be collected to determine the percent of the total radioactive dose recovered from feces.
Measured: At designated timepoints (up to approximately 5 weeks post-dose)
Total Number of Metabolites in Plasma that Represent at least 10% of the Dose of Radioactivity
Plasma samples will be collected at pre-specified timepoints and used to determine the total number of metabolites that represent at least 10% of the dose of radioactivity. Metabolites will be determined using liquid scintillation and high-resolution mass spectrometry.
Measured: At designated timepoints (up to approximately 5 weeks post-dose)
Total Number of Metabolites in Urine that Represent at least 10% of the Dose of Radioactivity
Urine samples will be collected at pre-specified timepoints and used to determine the total number of metabolites that represent at least 10% of the dose of radioactivity. Metabolites will be determined using liquid scintillation and high-resolution mass spectrometry.
Measured: At designated timepoints (up to approximately 5 weeks post-dose)
Total Number of Metabolites in Feces that Represent at least 10% of the Dose of Radioactivity
Fecal samples will be collected at pre-specified timepoints and used to determine the total number of metabolites that represent at least 10% of the dose of radioactivity. Metabolites will be determined using liquid scintillation and high-resolution mass spectrometry.
Measured: At designated timepoints (up to approximately 5 weeks post-dose)
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 the study intervention, whether or not considered related to the study intervention.
Measured: Up to approximately 7 weeks
Number of Participants Who Discontinue the Study Due to an AE
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of the study intervention, whether or not considered related to the study intervention.
Measured: Up to approximately 7 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2025
- Study start19 Mar 2025
- Primary completion4 Jun 2025
- Study completion4 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- NCT06826989
- Sponsor's protocol ID
- 8527-013
- Other IDs
- MK-8527-013
- Status last verified
- Jun 2025
- First submitted
- 10 Feb 2025
- Last updated
- 11 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study to Evaluate the Absorption, Metabolism, and Excretion of [14C]MK-8527 in Healthy Adult Participants
- ClinicalTrials.gov ID
- NCT06826989
- Acronym / sponsor ID
- 8527-013
- 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
- 19 Mar 2025 (actual)
- Primary completion
- 4 Jun 2025 (actual)
- Study completion
- 4 Jun 2025 (actual)
- First posted
- 14 Feb 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 learn how [14C]MK-8527 moves through a healthy person's body over time. Researchers will study how [14C]MK-8527 is absorbed by the body, broken down by the body, and how it leaves the body.
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-8527 | Experimental | Drug: [14C]MK-8527Participants will receive a single oral dose of [14C]MK-8527 on Day 1 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Is in good health
- Has a body mass index (BMI) of 18 to 32 kg/m^2
Key exclusion criteria (2 listed)
- Has a history of cancer
- Has positive tests for hepatitis B surface antigen, hepatitis C antibodies or human immunodeficiency virus
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-8527Oral Dose | Drug | [14C]MK-8527 |
Primary outcome
Cumulative Percentage of Total Radioactivity Recovered (fe) from Urine and Feces
Time frame: At designated timepoints (up to approximately 5 weeks post-dose)
Urine and fecal samples will be collected to determine the cumulative percentage of radioactivity recovered from both urine and feces.
Fe from Urine
Time frame: At designated timepoints (up to approximately 5 weeks post-dose)
Urine samples will be collected to determine the percent of total radioactivity recovered from urine.
Fe from Feces
Time frame: At designated timepoints (up to approximately 5 weeks post-dose)
Fecal samples will be collected to determine the percent of total radioactivity recovered from feces.
Plasma MK-8527: Area Under the Concentration-Time Curve from Time 0 to 24 Hours Post-dose (AUC0-24)
Time frame: At designated timepoints (up to 24 hours post-dose)
Plasma samples will be collected to determine the AUC0-24 of MK-8527.
Plasma MK-8527: Maximum Observed Concentration (Cmax)
Time frame: At designated timepoints (up to approximately 14 days post-dose)
Plasma samples will be collected to determine the Cmax of MK-8527.
Plasma MK-8527: Concentration at 24 Hours Post-dose (C24)
Time frame: At designated timepoints (up to 24 hours post-dose)
Plasma samples will be collected to determine the C24 of MK-8527.
Plasma MK-8527: Time of the Maximum Observed Concentration (Tmax)
Time frame: At designated timepoints (up to approximately 14 days post-dose)
Plasma samples will be collected to determine the Tmax of MK-8527.
Plasma Total Radioactivity: AUC0-24
Time frame: At designated timepoints (up to 24 hours post-dose)
Plasma samples will be collected to determine the AUC0-24 of total radioactivity.
Plasma Total Radioactivity: Cmax
Time frame: At designated timepoints (up to approximately 5 weeks post-dose)
Plasma samples will be collected to determine the Cmax of total radioactivity.
Plasma Total Radioactivity: C24
Time frame: At designated timepoints (up to 24 hours post-dose)
Plasma samples will be collected to determine the C24 of total radioactivity.
Plasma Total Radioactivity: Tmax
Time frame: At designated timepoints (up to approximately 5 weeks post-dose)
Plasma samples will be collected to determine the Tmax of total radioactivity.
Whole Blood Total Radioactivity: AUC0-24
Time frame: At designated timepoints (up to 24 hours post-dose)
Whole blood samples will be collected to determine the AUC0-24 of total radioactivity.
Whole Blood Total Radioactivity: Cmax
Time frame: At designated timepoints (up to approximately 5 weeks post-dose)
Whole blood samples will be collected to determine the Cmax of total radioactivity.
Whole Blood Total Radioactivity: C24
Time frame: At designated timepoints (up to 24 hours post-dose)
Whole blood samples will be collected to determine the C24 of total radioactivity.
Whole blood Total Radioactivity: Tmax
Time frame: At designated timepoints (up to approximately 5 weeks post-dose)
Whole blood samples will be collected to determine the Tmax of total radioactivity.
Cumulative Amount of Radioactivity Recovered from Urine
Time frame: At designated timepoints (up to approximately 5 weeks post-dose)
Urine samples will be collected to determine the cumulative amount of radioactivity recovered from urine.
Percent of Total Radioactive Dose Recovered from Urine
Time frame: At designated timepoints (up to approximately 5 weeks post-dose)
Urine samples will be collected to determine the percent of the total radioactive dose recovered from urine.
Cumulative Amount of Radioactivity Recovered from Feces
Time frame: At designated timepoints (up to approximately 5 weeks post-dose)
Fecal samples will be collected to determine the cumulative amount of radioactivity recovered from feces.
Percent of Total Radioactive Dose Recovered from Feces
Time frame: At designated timepoints (up to approximately 5 weeks post-dose)
Fecal samples will be collected to determine the percent of the total radioactive dose recovered from feces.
Total Number of Metabolites in Plasma that Represent at least 10% of the Dose of Radioactivity
Time frame: At designated timepoints (up to approximately 5 weeks post-dose)
Plasma samples will be collected at pre-specified timepoints and used to determine the total number of metabolites that represent at least 10% of the dose of radioactivity. Metabolites will be determined using liquid scintillation and high-resolution mass spectrometry.
Total Number of Metabolites in Urine that Represent at least 10% of the Dose of Radioactivity
Time frame: At designated timepoints (up to approximately 5 weeks post-dose)
Urine samples will be collected at pre-specified timepoints and used to determine the total number of metabolites that represent at least 10% of the dose of radioactivity. Metabolites will be determined using liquid scintillation and high-resolution mass spectrometry.
Total Number of Metabolites in Feces that Represent at least 10% of the Dose of Radioactivity
Time frame: At designated timepoints (up to approximately 5 weeks post-dose)
Fecal samples will be collected at pre-specified timepoints and used to determine the total number of metabolites that represent at least 10% of the dose of radioactivity. Metabolites will be determined using liquid scintillation and high-resolution mass spectrometry.
2 secondary outcomes
Number of Participants Who Experience an Adverse Event (AE)
Time frame: Up to approximately 7 weeks
Number of Participants Who Discontinue the Study Due to an AE
Time frame: Up to approximately 7 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2025.
- Merck Clinical Trials InformationLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
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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 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-8527 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 2 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 11 Jun 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?
Cumulative Percentage of Total Radioactivity Recovered (fe) from Urine and Feces (time frame: At designated timepoints (up to approximately 5 weeks post-dose)). The study lists 22 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 11 Jun 2025.